E048042.Draft-Revisions.Pdf

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Risk factors, symptom reporting, healthcare-seeking behaviour and adherence to public health guidance: protocol for Virus Watch, a prospective community cohort study

ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-048042

Article Type: Protocol

Date Submitted by the 22-Dec-2020 Author:

Complete List of Authors: Hayward, Andrew; University College London, Institute of Epidemiology and Health Care Fragaszy, Ellen; University College London, Centre for Public Health Data Science, Institute of Health Informatics; LSHTM, Department of Infectious Disease Epidemiology Kovar, Jana; University College London, Institute of Epidemiology and Health Care Nguyen, Vincent; University College London, Institute of Epidemiology and Health Care; University College London, Centre for Public Health Data Science, Institute of Health Informatics

Beale, Sarah; University College London, Institute of Epidemiology and http://bmjopen.bmj.com/ Health Care; University College London, Centre for Public Health Data Science, Institute of Health Informatics Byrne, Thomas; University College London, Centre for Public Health Data Science, Institute of Health Informatics Aryee, Anna; University College London, Centre for Public Health Data Science, Institute of Health Informatics Hardelid, Pia; University College London, Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health

Wijlaars, Linda; UCL, Population, Policy and Practice; University College on September 29, 2021 by guest. Protected copyright. London, Primary Care and Population Health Fong, Wing Lam Erica; University College London, Centre for Public Health Data Science, Institute of Health Informatics Geismar, Cyril; University College London, Institute of Epidemiology and Health Care; University College London, Centre for Public Health Data Science, Institute of Health Informatics Patel, Parth; University College London, Centre for Public Health Data Science, Institute of Health Informatics Shrotri, Madhumita; University College London, Centre for Public Health Data Science, Institute of Health Informatics Navaratnam, Annalan M D; University College London, Institute of Epidemiology and Health Care; University College London, Centre for Public Health Data Science, Institute of Health Informatics Nastouli, Eleni ; Francis Crick Institute; University College London, Department of Population, Policy and Practice Spyer, Moira; Francis Crick Institute Killingley, Ben; University of Nottingham School of Medicine; University College London Hospital

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Cox, Ingemar; University College London, Department of Computer 4 Science 5 Lampos, Vasileios; University College London, Department of Computer 6 Science 7 McKendry, Rachel; University College London, London Centre for 8 Nanotechnology and Division of Medicine 9 Liu, Yunzhe; University College London, SpaceTimeLab, Civil, Environmental and Geomatic Engineering. 10 Cheng, Tao; University College London, SpaceTimeLab, Department of 11 Civil, Environmental and Geomatic Engineering 12 Johnson, Anne; University College London, Institute for Global Health 13 Michie, Susan; University College London, Centre for Behaviour Change 14 Gibbs, Jo; University College London, Institute for Global Health 15 Gilson, Richard; University College London, Institute for Global Health 16 Rodger, Alison; University College London, Department of Infection and For peerPopulation Health; review Royal Free London only NHS Foundation Trust 17 Aldridge, Robert; University College London, Centre for Public Health 18 Data Science, Institute of Health Informatics 19 COVID-19, Public health < INFECTIOUS DISEASES, Epidemiology < 20 Keywords: 21 INFECTIOUS DISEASES 22 23 24 25 26 27 28 29 30 31

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4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 7 8 9 I, the Submitting Author has the right to grant and does grant on behalf of all authors of the Work (as defined 10 in the below author licence), an exclusive licence and/or a non-exclusive licence for contributions from authors 11 who are: i) UK Crown employees; ii) where BMJ has agreed a CC-BY licence shall apply, and/or iii) in accordance 12 with the terms applicable for US Federal Government officers or employees acting as part of their official 13 duties; on a worldwide, perpetual, irrevocable, royalty-free basis to BMJ Publishing Group Ltd (“BMJ”) its 14 licensees and where the relevant Journal is co-owned by BMJ to the co-owners of the Journal, to publish the 15 Work in this journal and any other BMJ products and to exploit all rights, as set out in our licence. 16 17 The Submitting Author accepts and understands that any supply made under these terms is made by BMJ to 18 the Submitting Author Forunless you peer are acting as review an employee on behalf only of your employer or a postgraduate 19 student of an affiliated institution which is paying any applicable article publishing charge (“APC”) for Open 20 Access articles. Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 4 Risk factors, symptom reporting, healthcare-seeking 5 6 behaviour and adherence to public health guidance: protocol 7 8 for Virus Watch, a prospective community cohort study 9 10 11 Andrew Hayward1, Ellen Fragaszy2,3, Jana Kovar1, Vincent Nguyen1,2, Sarah Beale1,2, Thomas 12 Byrne2, Anna Aryee2, Pia Hardelid4, Linda Wijlaars4, Wing Lam Erica Fong2, Cyril Geismar1,2, 13 14 Parth Patel2, Madhumita Shrotri2, Annalan M D Navaratnam1,2, Eleni Nastouli5,6, Moira Spyer6,, 15 7,8 9 9 10 11 16 Ben Killingley , IngemarFor Cox peer, Vasileios Lamposreview,Rachel A onlyMcKendry , Yunzhe Liu , Tao 17 Cheng11, Anne M Johnson13, Susan Michie12, Jo Gibbs13, Richard Gilson13, Alison Rodger13,14, 18 19 Robert W Aldridge2 20 21 22 Affiliations 23 24 25 26 1 Institute of Epidemiology and Health Care, University College London, London, UK 27 2 Centre for Public Health Data Science, Institute of Health Informatics, University College 28 29 London, UK. 30 3 Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical 31

32 Medicine, Keppel Street, London, UK. http://bmjopen.bmj.com/ 33 34 4 UCL Great Ormond Street Institute of Child Health, London, UK. 35 5 Department of Population, Policy and Practice, UCL Great Ormond Street Institute of Child 36 37 Health, London, UK. 38 6 Francis Crick Institute, London, UK. 39

40 7 Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, on September 29, 2021 by guest. Protected copyright. 41 42 University of Nottingham School of Medicine, Nottingham, United Kingdom. 43 8 University College London Hospital, London, United Kingdom. 44 45 9 Department of Computer Science, University College London, London, UK. 46 10 London Centre for Nanotechnology and Division of Medicine, London, UCL. 47 48 11 SpaceTimeLab, Department of Civil, Environmental and Geomatic Engineering, University 49 College London, London, UK. 50 51 12 Centre for Behaviour Change, University College London, London, UK. 52 53 13 Institute for Global Health, University College London, London, UK. 54 14 Royal Free London NHS Foundation Trust, London, UK. 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Corresponding Author: 4 5 Andrew Hayward, Institute of Epidemiology and Health Care, University College London, 6 London, WC1E 7HB, UK 7 8 9 10 Emails: 11 12 13 Andrew Hayward [email protected], Ellen Fragaszy [email protected] , Jana Kovar 14 [email protected], Vincent Nguyen [email protected], Sarah Beale 15 16 [email protected], Thomas peer Byrne review [email protected] only, Anna Aryee [email protected], 17 Pia Hardelid [email protected], Linda Wijlaars [email protected], Wing Lam Erica 18 19 Fong [email protected], Cyril Geismar [email protected], Parth Patel 20 21 [email protected], Madhumita Shrotri [email protected], Annalan M D 22 Navaratnam [email protected], Eleni Nastouli [email protected], Moira Spyer 23 24 [email protected], Ben Killingley [email protected], Ingemar Cox [email protected], 25 Vasileios Lampos [email protected], Rachel A McKendry [email protected] Tao 26 27 Cheng [email protected], Anne M Johnson [email protected], Susan Michie 28 [email protected], Jo Gibbs [email protected], Richard Gilson [email protected], Alison 29 30 Rodger [email protected], Robert W Aldridge [email protected] 31

32 http://bmjopen.bmj.com/ 33 Word count: 3975 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 4 Abstract 5 6 Introduction: The Coronavirus (COVID-19) Pandemic has caused significant global mortality 7 and impacted lives around the world. Virus Watch aims to provide evidence on which public 8 9 health approaches are most likely to be effective in reducing transmission and impact of the 10 11 virus, and will investigate community incidence, symptom profiles, and transmission of COVID- 12 19 in relation to population movement and behaviours. 13 14 Methods and analysis: Virus Watch is a household community cohort study of acute 15 respiratory infections in England & Wales and will run from June 2020 to Sept 2021. The study 16 For peer review only 17 aims to recruit 42,500 people, including 12,500 from minority ethnic backgrounds, for an online 18 19 survey cohort. Nested within this larger study will be a sub-cohort of 10,000 individuals, 20 including 3,000 people from minority ethnic backgrounds. This cohort of 10,000 people will have 21 22 full blood serology taken between October 2020 and January 2021 and repeat serology 23 between May 2021 and August 2021. Participants will also post self-administered nasal swabs 24 25 for PCR assays of SARS-CoV-2 and will follow one of three different PCR testing schedules 26 based upon symptoms. 27 28 Ethics and dissemination: This study has been approved by the Hampstead NHS Health 29 30 Research Authority Ethics Committee. Ethics approval number – 20/HRA/2320. We are 31 monitoring participant queries and using these to refine methodology where necessary, and are

32 http://bmjopen.bmj.com/ 33 providing summaries of our preliminary findings to inform public health action by working 34 through our partnerships with our study advisory group, Public Health England, NHS and 35 36 Government Scientific Advisory panels. 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 Keywords: COVID-19; UK; cohort study; epidemiology 42 43 44 45 Strengths and limitations of this study 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 1. Virus Watch is a large national household community cohort study of the 4 5 occurrence and risk factors for COVID-19 infection that aims to recruit 42,500 6 7 people, including 12,500 from minority ethnic backgrounds. 8 2. Virus Watch is designed to estimate incidence of PCR confirmed COVID-19 in 9 10 those with respiratory and non-respiratory presentations and the incidence of 11 12 hospitalisation among PCR confirmed COVID-19 cases. 13 14 3. Virus Watch will measure effectiveness and impact of recommended COVID-19 15 control measures including testing, isolation, social distancing, respiratory and 16 For peer review only 17 hand hygiene measures on risk of respiratory infection. 18 19 4. Only households with a lead householder able to speak English were able to take 20 21 part in the study up until December 2020. From Jan 2021, translations of the 22 online survey will be implemented for individuals recruited from this point 23 24 onwards. 25 26 5. Only households of up to six people were eligible for inclusion. 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 Introduction 34 35 The Coronavirus disease 2019 (COVID-19) pandemic has caused millions of deaths 36 37 and impacted lives around the world with the closure of schools, workplaces, and 38 39 limitations on freedom of movement. Vaccines and effective scalable treatments for

40 on September 29, 2021 by guest. Protected copyright. 41 COVID-19 are being discovered, but whilst these are still being approved and further 42 refined, we will need to rely on other measures to stop the spread of COVID-19. We will 43 44 also require studies to examine their effectiveness as they are implemented across 45 46 England and Wales. 47 COVID-19 transmission in the UK has started to increase since the end of August 2020. 48 49 Governments, including those of the UK devolved nations, are adopting a wide range of 50 51 control measures to limit the spread of infection. These include isolation of people with 52 53 COVID-19 symptoms and their household contacts, widespread testing and contact 54 tracing, digital contact tracing using mobile phone apps, broad social distancing 55 56 measures, and local control measures. Environmental cleaning, hand hygiene and face 57 58 mask use are also advised. 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Much of our current knowledge of COVID-19 comes from observations at the more 4 5 severe end of the disease spectrum, in hospitalised patients and individuals who die 6 7 having tested positive for the disease.[1–3] Although large-scale studies of prevalence 8 of PCR positive infection and seroprevalence have been established, there is currently 9 10 limited information on symptom profiles through the course of illness in non hospitalised 11 12 populations, children, social and behavioural risk factors for infection, strength and 13 14 duration of immunity, household and community transmission risk, and population 15 behaviours during periods of wellness and illness (including social contacts, use of 16 For peer review only 17 public spaces, testing behaviours, isolation, mask use, hand and respiratory hygiene). 18 19 This information can only be gathered accurately through prospective large-scale 20 21 community cohorts. Our experience of the MRC/Wellcome Flu Watch study[4,5] and 22 ESRC Bug Watch[6] study has allowed us to rapidly establish a national household 23 24 cohort study of 42,500 individuals. 25 26 Virus Watch aims to provide evidence on which public health approaches are most 27 likely to be effective in reducing the spread and impact of the virus and will investigate 28 29 community incidence, symptom profiles, and transmission of COVID-19 in relation to 30 31 population movement and behaviour.

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

32 Figure 1. Overview of cohort recruitment and data collection for the Virus Watch http://bmjopen.bmj.com/ 33 34 household community cohort study. 35 36 37 Households self-select into the study if they live in England and Wales and all members 38 of a household need to consent to take part in the study to meet our inclusion criteria. 39

40 Households need to have an internet connection on a phone, tablet or computer, email, on September 29, 2021 by guest. Protected copyright. 41 42 and, up until the end of November 2020, at least one adult household member that can 43 44 read English. From December 2020 onwards, online surveys will be translated into 45 multiple languages. A household is defined as one or more people (not necessarily 46 47 related) whose usual residence (4 days/week or more) is at the same address. These 48 49 householders share cooking facilities, a living room or sitting room or dining area. 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Primary outcomes 4 5 6 Study 1: Online Survey Cohort 7 8 1. Incidence of respiratory infection symptoms, including COVID-19 disease case 9 10 definitions. 11 12 2. Effectiveness and impact of recommended COVID-19 control measures including 13 testing, isolation, social distancing, respiratory and hand hygiene measures on 14 15 risk of respiratory infection. 16 For peer review only 17 3. Frequency of adherence with public-health recommendations for these control 18 19 measures. 20 4. Proportion of community infections that result in hospital admissions and death. 21 22 23 24 25 26 Study 2: Laboratory testing sub-cohort 27 1. Incidence of PCR confirmed COVID-19. 28 29 2. Incidence of PCR confirmed COVID-19 in those with non-respiratory 30 31 presentations.

32 http://bmjopen.bmj.com/ 33 3. Incidence of hospitalisation among PCR confirmed COVID-19 cases. 34 4. Proportion of individuals with SARS-CoV-2 antibodies acquired through natural 35 36 infection to pandemic coronavirus. 37 38 5. Proportion of individuals with cross-reacting antibodies to seasonal 39 coronaviruses acquiring (or not) SARS-CoV-2.

40 on September 29, 2021 by guest. Protected copyright. 41 6. Household secondary attack rates. 42 43 7. Protective effect of antibodies on infection and re-infection as well as the severity 44 45 and spectrum of presentation. 46 47 48 49 50 Recruitment 51 52 53 We will use the Royal Mail Post Office Address File to generate a list of residential 54 address lists from which households can be sampled and sent Virus Watch recruitment 55 56 postcards to. The proposed initial sample design is a single-stage stratified probability 57 58 sample where implicit stratification is employed to benefit from the precision gains that 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 10 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 stratified sampling can bring. Within each region, residential addresses are sorted by (a) 4 5 quintiles of Index of Multiple Deprivation 2019 (IMD), (b) within quintiles by Local 6 7 Authorities, (c) postcodes and (d) address. We will perform this in the 9 Government 8 Office Regions of England as well as Wales (10 study regions in total). 9 10 11 12 We will assess recruitment rates and the representativeness of this initial sample 13 14 following the mail out of 50,000 postcards. If recruitment is lower than expected or 15 under-representative of the national population, we will redesign our recruitment 16 For peer review only 17 campaign to include a range of methods in order to build the cohort. This mixed 18 19 recruitment strategy will be flexible and use a variety of methods including social media, 20 21 study leaflet drops, text messaging, personalised letters and incentives. Social media 22 adverts will be used to inform individuals about the study and direct them to our website 23 24 http://ucl-virus-watch.net/ where they can read the participant information sheets and 25 26 consent to taking part. Digital invitations will also be created for sharing via WhatsApp. 27 Text messages and postal letters inviting patients from their General Practitioner clinics 28 29 will be organised via Local Clinical Research Networks.[7] We will also work with trusted 30 31 community partners and religious organisations to promote recruitment into the study.

32 http://bmjopen.bmj.com/ 33 34 In order for a household to be enrolled, they will require an internet connection (Wi-Fi, 35 36 fixed or on a mobile phone), email address, and all household members must agree to 37 38 take part. Households will nominate a lead householder who will submit study 39 questionnaires. Up until December 2020, the lead householder will need to be able to

40 on September 29, 2021 by guest. Protected copyright. 41 read English to support other household members in survey completion. From 42 43 December 2020 onwards, online surveys will be translated into multiple languages and 44 45 this will no longer be an inclusion criteria. A household is defined as one or more people 46 (not necessarily related) whose usual residence (4 days/week or more) is at the same 47 48 address. These householders share cooking facilities, and may share a living room or 49 50 sitting room or dining area if available. Households with more than six members will not 51 52 be eligible for the study - this criteria was set due to limitations of the REDCap survey 53 infrastructure which did not function correctly when attempting to work with household 54 55 sizes of greater than six during our pilot testing of the survey. 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Virus Watch is powered for our primary aims in study 2 and the estimation of 4 5 population-level symptomatic COVID-19 attack rate over time. Based on an estimated 6 7 clinical attack rate of 30% of whom 20% need hospitalisation, and 0.5% die we expect 8 the following number of outcome events in our cohort of 10,000 individuals in study 2: 9 10 3000 COVID-19 illnesses, 600 hospitalised cases, and 15 deaths. At one month into the 11 12 outbreak we would be able to detect a 1.7-fold greater risk of disease in a population 13 14 subgroup that constitutes 1/5 of the population, and by 2 months the detectable relative 15 risk would be only 1.2. At one month we could detect a 4% hospital admission rate 16 For peer review only 17 amongst cases with 95% CI of 0.5-6.8, and by 2 months the confidence intervals would 18 19 narrow to 3.1-4.1. We have used estimates of the expected number of events over time 20 21 to provide an indication of the fact that the cohort is sufficiently large to provide valuable 22 information through the course of the pandemic. Sample size calculations have been 23 24 informed by a realistic assessment of what we can achieve based on our previous 25 26 experience[4,6]. For the serology cohort of 3000 people from minority ethnic 27 backgrounds we assume a modest design effect (DE) due to household and 28 29 geographical clustering, and 500 participants for six different minority ethnic 30 31 backgrounds to enable the measurement of a cumulative incidence of 10% with 95%

32 http://bmjopen.bmj.com/ 33 confidence intervals of 3% by each minority ethnic group. 34 35 36 37 38 Participant materials and incentives 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 Participant information sheets will be held on our study website. In order to participate, 43 the whole household must take part. Each adult participant will need to read through 44 45 study information, and provide online informed consent for themselves and any children 46 47 they are legally responsible for. Children aged 6-9 and 10-15 years respectively will 48 also be asked to read through age specific study participant information sheets and 49 50 provide online informed assent. For children aged 5 and under, parents/guardians will 51 52 consent on their behalf. Copies of translated consent questions will be provided where 53 54 possible for those unable to read English. Informed consent data will be securely stored 55 in UCL’s Data Safe Haven which has been certified to the ISO27001 information 56 57 security standard and conforms to NHS Digital's Data Security and Protection Toolkit. 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 12 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Local study teams will re-consent participants face to face, prior to undertaking blood 4 5 sampling, and adult participants in study 2 will be offered a £10 voucher to reimburse 6 7 travel costs. We will seek ethical approval for the use of recruitment incentives if levels 8 of recruitment are lower than expected. 9 10 11 Data collection and follow-up 12 13 14 15 Study 1: Online Survey Cohort 16 For peer review only 17 18 The online survey cohort will collect data and follow up participants through six different 19 20 sources. Survey data will be collected using Research Electronic Data Capture 21 22 (REDCap) electronic data capture tools hosted on the UCL Data Safe Haven.[8] 23 24 REDCap is a secure, web-based application for research studies. The UCL Data Safe 25 Haven provides a technical solution for storing, handling and analysing identifiable data. 26 27 It has been certified to the ISO27001 information security standard and conforms to 28 29 NHS Digital’s Data Security and Protection Toolkit . 30 31

32 1) Baseline Survey. The http://bmjopen.bmj.com/ 33 34 Lead Householder will be asked to complete an online baseline survey for each 35 36 member of their household. Information collected includes: demographics, occupation, 37 income, ethnicity, country of birth, year of entry to UK, chronic medical conditions, 38 39 medications, pregnancy status, vaccines, mode of transport to work, any previous

40 on September 29, 2021 by guest. Protected copyright. 41 contact with someone with COVID-19, previous symptoms of COVID-19-like illness and 42 infection-prevention behaviours such as social distancing and hand hygiene. 43 44 45 46 2) Illness Surveys. 47 48 Participants will be followed-up weekly via an email with a link to an illness survey. This 49 is a weekly survey of the presence or absence of symptoms that could indicate COVID- 50 51 19 disease including respiratory, general infection symptoms or gastrointestinal 52 53 symptoms. During illness, prospective daily symptom recording, quality of life, health 54 55 seeking behaviour (NHS 111, GP in person, GP by phone, A&E, Pharmacy, Hospital), 56 treatments, and NHS investigations will be recorded. This survey will also include any 57 58 respiratory and hygiene measures, self-isolation, activities and social contact, travel and 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 13 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 face mask use. The survey includes questions to the household on activities undertaken 4 5 in the week prior to symptom onset. The weekly survey will also be used to capture test 6 7 results received from outside the study and requests to self isolate eg. via the UK Test- 8 Trace-Isolate system. 9 10 11 12 3) Monthly Surveys. A 13 14 number of questions will be asked every month. The monthly surveys also provide 15 flexibility to ask additional questions (eg. behavioural changes) to reflect any new 16 For peer review only 17 government directives on social distancing, testing, contact tracing, and vaccine 18 19 delivery. Core questions will also allow us to follow up reasons for any non-response in 20 21 a given month- (e.g. because of illness, hospitalisation or holiday). We will also ask 22 about online health information seeking, social distancing, including recent (week 23 24 before) contacts, activities, places visited and hand & respiratory hygiene. We will ask 25 26 about finances, employment, and mental health to see how the COVID-19 response is 27 affecting participants’ wellbeing and ability to work. We will ask about access to 28 29 healthcare for non–COVID-19 health problems to explore the indirect health impacts of 30 31 the pandemic. We will ask about any COVID-19 PCR or antibody test results performed

32 http://bmjopen.bmj.com/ 33 outside the study and not already reported through baseline surveys. We will ask about 34 influenza vaccine uptake and COVID-19 vaccination intentions and uptake. 35 36 37 38 4) Data Linkage. NHS 39 Digital will undertake quarterly data linkage between cohort 1 and Hospital Episode

40 on September 29, 2021 by guest. Protected copyright. 41 Statistics (HES), which includes admitted patient and critical care episodes, outpatient 42 43 department bookings, and emergency care contacts. This linkage will also include 44 45 Office for National Statistics mortality data and virology testing data routinely collected 46 by Public Health England, Public Health Wales, and the Department of Health and 47 48 Social Care through ‘Pillar 1’ (testing in hospital patients and health and care workers) 49 50 and ‘Pillar 2’ (community testing). These data sources will be linked to the cohort using 51 52 name, NHS numbers, dates of birth and postal address. Identifying variables will be 53 removed before the linked data are transferred back to UCL for analysis. These data 54 55 linkages will continue for up to 5 years after the end of the study as we anticipate 56 57 COVID-19 will become a recurring winter infection and we wish to understand its impact 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 14 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 on health services in subsequent years. These linkage studies will identify any 4 5 participants that have been admitted to hospital or died due to causes that could be 6 7 directly or indirectly linked to the COVID-19 pandemic. Indirect causes include those 8 related to limitations in healthcare access during the pandemic. Reductions in the use 9 10 of routine health services will also be monitored via linkage to HES data. 11 12 13 14 5) Geo-location Tracking. 15 All adult participants will be asked about optional consent to use a secure geo-location 16 For peer review only 17 tracking app (Tracker for ArcGIS) installed on their mobile phone for the duration of the 18 19 study. 20 21 22 6) Home antibody finger prick tests. 5000 members of the online cohort who are not 23 24 part of the Laboratory testing sub-cohort (including 2500 minority ethnic and 2500 White 25 26 British people) will be offered home finger prick antibody testing kits as soon as 27 available after the first wave of the pandemic and after the second wave of the 28 29 pandemic. 30 31

32 http://bmjopen.bmj.com/ 33 Study 2: Laboratory testing sub-cohort 34 35 36 All participants agreeing to take part in the main cohort (study 1) will be asked to 37 38 provide consent to be contacted and invited to participate in one of the three laboratory 39 testing sub-groups. This will enable a cohort of 10,000 individuals selected from the 40 on September 29, 2021 by guest. Protected copyright. 41 42 main cohort of 42,500 individuals to be maximally representative of the population of 43 England and Wales. All participants taking part in study 2 will be asked to use the 44 45 national test, trace and isolation system in addition to providing samples as part of Virus 46 47 Watch. 48 49 50 Study 2 will consist of three groups that will follow different schedules of antibody testing 51 52 and nasal/throat swabs for PCR testing. 53 54 55 Group 1 (n=7000): 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 15 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 With data from this group we aim to identify infection in those with a wide range of 4 5 respiratory symptoms. Participants will be asked to submit a nose/throat swab if they 6 7 experience two consecutive days of: fever (>37.8), feeling feverish, or new persistent 8 cough, or loss or altered sense of smell or taste (COVID-19 suspected case definition), 9 10 or shortness of breath, or ear pain or change in hearing, or sore throat, or sneezing, or 11 12 blocked nose, or runny nose, or wheeze or sinus pain or congestion (other respiratory 13 14 manifestations). 15 16 For peer review only 17 Group 2 (n=1000): 18 19 This group aims to identify the importance of non-respiratory presentations. Participants 20 21 will be asked to submit a self-taken nasal/throat swab for PCR identification of COVID- 22 19 and other respiratory viruses if: 23 24 ● Either - two consecutive days of respiratory symptoms (e.g. cough, runny nose, 25 26 sneezing, shortness of breath, sore throat, blocked nose, sinus pain or 27 congestion, ear pain or change in hearing, wheezing, loss of or altered sense of 28 29 taste or sense of smell). 30 31 ● OR – two consecutive days of gastrointestinal symptoms (e.g. diarrhoea/loose

32 http://bmjopen.bmj.com/ 33 stools, abdominal pain, nausea or vomiting, loss of appetite). 34 ● OR - two consecutive days of general infection symptoms (e.g. feeling feverish, 35 36 having a high temperature, feelings of severe unexplained tiredness, generalised 37 38 muscle or joint aches) 39

40 on September 29, 2021 by guest. Protected copyright. 41 Group 3 (n = 2000): 42 43 This group aims to identify the extent of household transmission. Participants will be 44 45 asked to submit a nose/throat swab if they experience two consecutive days of cough or 46 fever or loss of sense of taste or smell. Household contacts of the index case will also 47 48 be asked to submit a swab on the same day whether or not they have symptoms. 49 50 51 52 If any of the swabs indicate SARS-COV-2 infection, all household members will be 53 asked to repeat the swab on Day 7 and Day 14. If there are no new SARS-COV-2 54 55 cases in the household arising from swabs on Day 7 and 14 (assumed secondary 56 57 cases) then all household members will be asked to undertake a home finger prick 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 16 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 antibody test on Day 21. If there is one or more secondary cases in the household then 4 5 the entire household will be asked to take an additional swab on day 21 and then 6 7 undertake the fingerprick antibody tests on Day 28. 8 9 10 End of follow-up 11 12 13 14 Online participant follow-up will end in May 2021 although depending on the 15 16 progression of COVID-19For wepeer may ask reviewparticipants to continue only in the study for longer. 17 Participants will be sent an exit survey via email which will also ask participants for 18 19 permission to be contacted for involvement in future related research. Participants will 20 21 be contacted to arrange a second blood sample collection from May 2021. Follow-up 22 23 through data linkage with Hospital Episode Statistics and Mortality data will continue for 24 5 years after the end of the study. 25 26 27 Laboratory testing 28 29 Antibody testing 30 31 Study 2 will be using two different types of antibody tests. First, full blood serology will

32 http://bmjopen.bmj.com/ 33 be taken between October 2020 and January 2021. We will use experienced health 34 35 care professionals, including research nurses from the NIHR Clinical Research 36 37 Networks.[9] Depending on local circumstances, visits to participants’ homes to take 38 39 blood may also be arranged. Children aged 15 years or less can opt out of having their

40 blood taken but will be offered a finger prick antibody test conducted by a healthcare on September 29, 2021 by guest. Protected copyright. 41 42 worker instead. All participants from laboratory group 3 will additionally be offered a 43 44 fingerprick antibody test at the same time as blood taking. From May 2021 until 45 September 2021, we will invite all participants back for full blood tests or, for children 46 47 who do not wish to have a full bleed, healthcare worker-delivered finger prick based 48 49 antibody tests. 50 51 52 Families of children who have not been able to attend for a blood test, or for a 53 54 healthcare worker-delivered finger prick antibody test, will be provided with postal kits to 55 56 perform these at home. We also plan to use finger prick antibody testing where local 57 58 clinics are no longer able to undertake full blood tests due to COVID-19 travel 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 17 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 restrictions. Extremely clinically vulnerable participants will be sent home fingerprick 4 5 tests instead of being asked to provide a serological sample. 6 7 8 Virus detection 9 10 Participants will post swab samples for PCR assays of COVID-19, and subsequent 11 12 testing for influenza virus, seasonal coronavirus, rhinovirus and respiratory syncytial 13 14 virus (RSV). When COVID-19 is identified we will also undertake whole genome 15 sequencing of the virus. Samples for COVID-19 diagnostics will be handled and 16 For peer review only 17 processed according to the NHS and UCL guidance on sample handling during the 18 19 COVID-19 pandemic. 20 21 22 COVID-19 PCR and serology results will be returned to participants via text and email 23 24 message systems. These messages will include links to official support, information and 25 26 advice from NHS and PHE as well as advice on how to interpret results based on 27 current evidence. In laboratory group 3, where positive test results will trigger further 28 29 testing of the household, the results email will also include details explaining the 30 31 additional testing requests.

32 http://bmjopen.bmj.com/ 33 34 35 Statistical analysis 36 37 38 39 Our primary analyses during the winter 2020/21 will focus on estimating age-specific

40 on September 29, 2021 by guest. Protected copyright. 41 weekly rates of symptoms and PCR-confirmed COVID-19 illness and hospitalisation. 42 For this analysis we will use appropriate regression models that account for clustering 43 44 by household and we will explore the use of stratification or weighting of the sample by 45 46 age and region as necessary to give nationally representative estimates. Weekly rates 47 will be expressed per 100,000 person-weeks for ease of comparison with national 48 49 surveillance data. 50 51 52 53 We will examine the proportion of the population infected during the first wave (e.g. Feb 54 2020 to Sept 2020) and second and potentially future pandemics waves. We will 55 56 estimate the percentage of the population infected by calculating age and wave-specific 57 58 rates of serological infection and PCR-confirmed disease per 100 person-seasons. A 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 18 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 person-season will be defined by the epidemic curve in the cohort and therefore rates 4 5 will account for differential follow-up time during each epidemic peak. In these analyses 6 7 we will examine risk factors for infection, disease, disease severity and disease 8 transmission. 9 10 11 12 We will estimate the proportion of serologically confirmed SARS-CoV-2 infections 13 14 leading to symptomatic disease. First, we will calculate age-adjusted attributable rates 15 of illness due to infection (subtracting rates of respiratory illness in non seroconverters 16 For peer review only 17 from those in seroconverters). Second, we will measure the proportion of 18 19 seroconverters with PCR-confirmed COVID-19. Analyses plans will be developed prior 20 21 to conducting all analyses. 22 23 24 Whilst the study is being conducted, we will produce early, preliminary results for 25 26 participants, the general public and policy makers in order to inform the public health 27 response to the pandemic. These analyses will be reactive to the epidemiological 28 29 circumstances and are therefore not defined in this protocol. 30 31

32 http://bmjopen.bmj.com/ 33 Modelling 34 We will build on our experience of working with PHE, Google, and Microsoft to use 35 anonymous national or subnational aggregate web search engine data[10,11] to monitor 36 37 the spreading of the disease. We will use our study data as ground-truth to train real- 38 39 time disease prevalence estimation algorithms. We will annotate GPS tracking data into

40 on September 29, 2021 by guest. Protected copyright. 41 standard categories including time at work and home, social venues, supermarkets, 42 hospitals, GPs, and transport mode for incorporation in classical epidemiological 43 44 analyses. Integrating the linked survey data, we will develop multi-level spatio-temporal 45 46 transmission models predicting the impact of various social distancing strategies. 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 19 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Patient and public involvement 4 5 6 Due to the urgent nature of this study, we did not involve participants in its original 7 8 design. We have previously conducted PPI to support similar community cohort studies 9 of acute infections using similar methodologies. We have engaged the Young Persons' 10 11 Advisory Group for research at Great Ormond Street Hospital to provide feedback on 12 13 our Children's Participant Information Sheets. We will provide opportunities for survey 14 15 participants to comment on survey methodology at the first monthly survey and consider 16 revisions based onFor this. Atpeer the baseline review survey, and each only month, we will ask 17 18 participants what questions are important to them (in relation to COVID-19 epidemiology 19 20 and response), and what research questions they would like us to answer. We are also 21 monitoring participant queries through our study email address and using these to refine 22 23 methodology where necessary. We have worked with the Race Equality Foundation and 24 25 Doctors of the World in advising on the inclusion of people from minority ethnic 26 27 backgrounds in Virus Watch and have set up an advisory group to inform the ongoing 28 design and dissemination of health equity aspects of Virus Watch. This advisory group 29 30 (consisting of lay members of the public, community leaders, charities and policy 31

32 organisation) will guide our health equity analyses and steer us on its implications for http://bmjopen.bmj.com/ 33 34 people, communities and policy. 35 36 37 38 39 Data sharing and access

40 on September 29, 2021 by guest. Protected copyright. 41 42 We aim to share aggregate data from this project on our website and via a “Findings so 43 44 far” section on our website - https://ucl-virus-watch.net/. We will also be sharing 45 46 individual record level data with personal identifiers removed on a research data sharing 47 service such as the UK Data Archive. In sharing the data we will work within the 48 49 principles set out in the UKRI Guidance on best practice in the management of research 50 51 data. https://www.ukri.org/files/legacy/documents/rcukcommonprinciplesondatapolicy- 52 53 pdf/. Access to use of the data whilst research is being conducted will be managed by 54 the Chief Investigators (ACH and RWA) in accordance with the principles set out in the 55 56 UKRI guidance on best practice in the management of research data. It is the intention 57 58 that the data arising from this research will initially be collected, cleaned and validated 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 20 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 by the UCL research team and once this has been completed will be shared for wider 4 5 use. We aim to make subsets of the data more rapidly available both on our study 6 7 website and via the public facing dashboard during the ongoing phase of data 8 collection. In line with Principle 5 of the UKRI guidance on best practice in the 9 10 management of research data, we plan to release data in batches as they become 11 12 available or as updated results are published. Individual record data linked using NHS 13 14 Digital will not be shared, only aggregated results. HES and mortality data may be 15 obtained from a third party and are not publicly available. These data are owned by a 16 For peer review only 17 third party and can be accessed by researchers applying to the Health and Social Care 18 19 Information Centre for England. We will put analysis code on publicly available 20 21 repositories to enable their reuse. 22 23 24 25 26 Ethics 27 28 29 30 This is a national study that has been approved by the Hampstead NHS Health 31 Research Authority Ethics Committee. Ethics approval number – 20/HRA/2320. The

32 http://bmjopen.bmj.com/ 33 study is compliant with the requirements of General Data Protection Regulation 34 35 (2016/679) and the Data Protection Act (2018). All investigators and study site staff will 36 37 comply with the requirements of the General Data Protection Regulation (2016/679) 38 39 with regards to the collection, storage, processing and disclosure of personal

40 information, and will uphold the Act’s core principles. on September 29, 2021 by guest. Protected copyright. 41 42 43 44 Author Contributions 45 46 Roles: Conceptualization (AH, EF, JK, PH, EN, BK, IC, VL, RAMcK, TC, AMJ, SM, JG, 47 48 RG, AR, RWA) Investigation, Methodology (All authors), Project Administration (AH, EF, 49 JK, VN, SB, TB, AA, PH, LW, WLEF, CG, PP, MSh, AMDN, EN, MSp, RWA) , Writing – 50 Original Draft Preparation (All Authors), Software (VN, TB, SB, RWA), Resources (AH, 51 EF, JK, PH, EN, BK, IC, VL, RAMcK, TC, AMJ, SM, JG, RG, AR, RWA), Writing – 52 Review & Editing (All Authors). 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 21 of 21 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Funding 4 5 6 The research costs for the study have been supported by the MRC Grant Ref: MC_PC 7 19070 awarded to UCL on 30 March 2020 and MRC Grant Ref: MR/V028375/1 8 9 awarded on 17 August 2020. The study also received $15,000 of advertising credit to 10 11 support a pilot social media recruitment campaign on 18th August 2020. 12 13 14 15 16 Competing interests:For ACH peerserves on the review UK New and Emerging only Respiratory Virus Threats 17 Advisory Group. AMJ was a Governor of Wellcome Trust from 2011-18 and is Chair of the 18 Committee for Strategic Coordination for Health of the Public Research. 19 20 21 22 References 23 24 25 26 27 28 1 Official UK Coronavirus Dashboard. https://coronavirus.data.gov.uk/ (accessed 30 Nov 29 2020). 30 31 2 Statistics. Statistics » COVID-19 Daily Deaths.

32 https://www.england.nhs.uk/statistics/statistical-work-areas/covid-19-daily-deaths/ http://bmjopen.bmj.com/ 33 (accessed 30 Nov 2020). 34 35 3 Coronavirus (COVID-19). 36 https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsand 37 diseases (accessed 30 Nov 2020). 38 39 4 Fragaszy EB, Warren-Gash C, Wang L, et al. Cohort Profile: The Flu Watch Study. Int J

40 Epidemiol 2017;46:e18. doi:10.1093/ije/dyv370 on September 29, 2021 by guest. Protected copyright. 41 42 5 Hayward AC, Fragaszy EB, Bermingham A, et al. Comparative community burden and 43 severity of seasonal and pandemic influenza: results of the Flu Watch cohort study. Lancet 44 Respir Med 2014;2:445–54. doi:10.1016/S2213-2600(14)70034-7 45 46 6 Smith CM, Conolly A, Fuller C, et al. Symptom reporting, healthcare-seeking behaviour and 47 antibiotic use for common infections: protocol for Bug Watch, a prospective community 48 cohort study. BMJ Open 2019;9:e028676. doi:10.1136/bmjopen-2018-028676 49 50 7 Clinical Research Network. https://www.nihr.ac.uk/explore-nihr/support/clinical-research- 51 network.htm (accessed 30 Nov 2020). 52 53 8 Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)--a 54 metadata-driven methodology and workflow process for providing translational research 55 informatics support. J Biomed Inform 2009;42:377–81. doi:10.1016/j.jbi.2008.08.010 56 57 9 Clinical Research Network. https://www.nihr.ac.uk/explore-nihr/support/clinical-research- 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 22 of 21 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 network.htm (accessed 30 Nov 2020). 4 5 10 Wagner M, Lampos V, Cox IJ, et al. The added value of online user-generated content in 6 traditional methods for influenza surveillance. Sci Rep 2018;8:13963. doi:10.1038/s41598- 7 018-32029-6 8 9 11 Lampos V, Majumder MS, Yom-Tov E, et al. Tracking COVID-19 using online search. arXiv 10 [cs.SI]. 2020.http://arxiv.org/abs/2003.08086v10 11 12 13 14 15 16 For peer review only 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

Risk factors, symptom reporting, healthcare-seeking behaviour and adherence to public health guidance: protocol for Virus Watch, a prospective community cohort study

ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2020-048042.R1

Article Type: Protocol

Date Submitted by the 29-Mar-2021 Author:

Complete List of Authors: Hayward, Andrew; UCL, Institute of Epidemiology and Health Care Fragaszy, Ellen; UCL, Centre for Public Health Data Science, Institute of Health Informatics; LSHTM, Department of Infectious Disease Epidemiology Kovar, Jana; UCL, Institute of Epidemiology and Health Care Nguyen, Vincent; UCL, Institute of Epidemiology and Health Care; University College London, Centre for Public Health Data Science, Institute of Health Informatics Beale, Sarah; UCL, Institute of Epidemiology and Health Care; University College London, Centre for Public Health Data Science, Institute of

Health Informatics http://bmjopen.bmj.com/ Byrne, Thomas; UCL, Centre for Public Health Data Science, Institute of Health Informatics Aryee, Anna; University College London, Centre for Public Health Data Science, Institute of Health Informatics Hardelid, Pia; University College London, Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health Wijlaars, Linda; UCL, Population, Policy and Practice; University College London, Primary Care and Population Health

Fong, Wing Lam Erica; University College London, Centre for Public on September 29, 2021 by guest. Protected copyright. Health Data Science, Institute of Health Informatics Geismar, Cyril; University College London, Institute of Epidemiology and Health Care; University College London, Centre for Public Health Data Science, Institute of Health Informatics Patel, Parth; University College London, Centre for Public Health Data Science, Institute of Health Informatics Shrotri, Madhumita; University College London, Centre for Public Health Data Science, Institute of Health Informatics Navaratnam, Annalan M D; University College London, Institute of Epidemiology and Health Care; University College London, Centre for Public Health Data Science, Institute of Health Informatics Nastouli, Eleni ; Francis Crick Institute; University College London, Department of Population, Policy and Practice Spyer, Moira; Francis Crick Institute Killingley, Ben; University of Nottingham School of Medicine; University College London Hospital Cox, Ingemar; UCL, Department of Computer Science Lampos, Vasileios; University College London, Department of Computer

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Science 4 McKendry, Rachel; University College London, London Centre for 5 Nanotechnology and Division of Medicine 6 Liu, Yunzhe; University College London, SpaceTimeLab, Civil, 7 Environmental and Geomatic Engineering. 8 Cheng, Tao; University College London, SpaceTimeLab, Department of 9 Civil, Environmental and Geomatic Engineering Johnson, Anne; University College London, Institute for Global Health 10 Michie, Susan; University College London, Centre for Behaviour Change 11 Gibbs, Jo; University College London, Institute for Global Health 12 Gilson, Richard; University College London, Institute for Global Health 13 Rodger, Alison; UCL, Institute for Global Health; Royal Free London NHS 14 Foundation Trust 15 Aldridge, Robert; UCL, Centre for Public Health Data Science, Institute of 16 For peerHealth Informatics review only 17 Primary Subject Public health 18 Heading: 19 20 Secondary Subject Heading: Epidemiology, Infectious diseases 21 COVID-19, Public health < INFECTIOUS DISEASES, Epidemiology < Keywords: 22 INFECTIOUS DISEASES 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

1 2 3

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 4 Risk factors, symptom reporting, healthcare-seeking 5 6 behaviour and adherence to public health guidance: protocol 7 8 for Virus Watch, a prospective community cohort study 9 10 11 Andrew Hayward1, Ellen Fragaszy2,3, Jana Kovar1, Vincent Nguyen1,2, Sarah Beale1,2, Thomas 12 Byrne2, Anna Aryee2, Pia Hardelid4, Linda Wijlaars4, Wing Lam Erica Fong2, Cyril Geismar1,2, 13 14 Parth Patel2, Madhumita Shrotri2, Annalan M D Navaratnam1,2, Eleni Nastouli5,6, Moira Spyer6,, 15 7,8 9 9 10 11 16 Ben Killingley , IngemarFor Cox peer, Vasileios Lamposreview, Rachel Aonly McKendry , Yunzhe Liu , Tao 17 Cheng11, Anne M Johnson13, Susan Michie12, Jo Gibbs13, Richard Gilson13, Alison Rodger13,14, 18 19 Robert W Aldridge2 20 21 22 Affiliations 23 24 1 Institute of Epidemiology and Health Care, University College London, London, UK 25 26 2 Centre for Public Health Data Science, Institute of Health Informatics, University College 27 London, UK. 28 29 3 Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical 30 Medicine, Keppel Street, London, UK. 31

32 4 UCL Great Ormond Street Institute of Child Health, London, UK. http://bmjopen.bmj.com/ 33 34 5 Department of Population, Policy and Practice, UCL Great Ormond Street Institute of Child 35 Health, London, UK. 36 37 6 Francis Crick Institute, London, UK. 38 7 Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, 39

40 University of Nottingham School of Medicine, Nottingham, United Kingdom. on September 29, 2021 by guest. Protected copyright. 41 42 8 University College London Hospital, London, United Kingdom. 43 9 Department of Computer Science, University College London, London, UK. 44 45 10 London Centre for Nanotechnology and Division of Medicine, London, UCL. 46 11 SpaceTimeLab, Department of Civil, Environmental and Geomatic Engineering, University 47 48 College London, London, UK. 49 12 Centre for Behaviour Change, University College London, London, UK. 50 51 13 Institute for Global Health, University College London, London, UK. 52 53 14. Royal Free London NHS Foundation Trust, London, UK. 54 55 56 57 Corresponding Author: 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Andrew Hayward, Institute of Epidemiology and Health Care, University College London, 4 5 London, WC1E 7HB, UK 6 7 8 Emails: 9 10 11 Andrew Hayward [email protected], Ellen Fragaszy [email protected] , Jana Kovar 12 13 [email protected], Vincent Nguyen [email protected], Sarah Beale 14 [email protected], Thomas Byrne [email protected], Anna Aryee [email protected], 15 16 Pia Hardelid [email protected] peer, Linda Wijlaarsreview [email protected] only , Wing Lam Erica 17 Fong [email protected], Cyril Geismar [email protected], Parth Patel 18 19 [email protected], Madhumita Shrotri [email protected], Annalan M D 20 21 Navaratnam [email protected], Eleni Nastouli [email protected], Moira Spyer 22 [email protected], Ben Killingley [email protected], Ingemar Cox [email protected], 23 24 Vasileios Lampos [email protected], Rachel A McKendry [email protected] Tao 25 Cheng [email protected], Anne M Johnson [email protected], Susan Michie 26 27 [email protected], Jo Gibbs [email protected], Richard Gilson [email protected], Alison 28 Rodger [email protected], Robert W Aldridge [email protected] 29 30 31 Word count: 4,600

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 4 Abstract 5 6 Introduction: The Coronavirus (COVID-19) Pandemic has caused significant global mortality 7 and impacted lives around the world. Virus Watch aims to provide evidence on which public 8 9 health approaches are most likely to be effective in reducing transmission and impact of the 10 11 virus, and will investigate community incidence, symptom profiles, and transmission of COVID- 12 19 in relation to population movement and behaviours. 13 14 Methods and analysis: Virus Watch is a household community cohort study of acute 15 respiratory infections in England & Wales and will run from June 2020 to August 2021. The 16 For peer review only 17 study aims to recruit 50,000 people, including 12,500 from minority ethnic backgrounds, for an 18 19 online survey cohort and monthly antibody testing using home finger prick kits. Nested within 20 this larger study will be a sub-cohort of 10,000 individuals, including 3,000 people from minority 21 22 ethnic backgrounds. This cohort of 10,000 people will have full blood serology taken between 23 October 2020 and January 2021 and repeat serology between May 2021 and August 2021. 24 25 Participants will also post self-administered nasal swabs for PCR assays of SARS-CoV-2 and 26 27 will follow one of three different PCR testing schedules based upon symptoms. 28 Ethics and dissemination: This study has been approved by the Hampstead NHS Health 29 30 Research Authority Ethics Committee. Ethics approval number – 20/HRA/2320. We are 31 monitoring participant queries and using these to refine methodology where necessary, and are

32 http://bmjopen.bmj.com/ 33 providing summaries and policy briefings of our preliminary findings to inform public health 34 35 action by working through our partnerships with our study advisory group, Public Health 36 England, NHS and Government Scientific Advisory panels. 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 Keywords: COVID-19; UK; cohort study; epidemiology 42 43 44 45 Strengths and limitations of this study 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 1. Virus Watch is a large national household community cohort study of the 4 5 occurrence and risk factors for COVID-19 infection that aims to recruit 50,000 6 7 people, including 12,500 from minority ethnic backgrounds. 8 2. Virus Watch is designed to estimate incidence of PCR confirmed COVID-19 in 9 10 those with respiratory and non-respiratory presentations and the incidence of 11 12 hospitalisation among PCR confirmed COVID-19 cases. 13 14 3. Virus Watch will measure effectiveness and impact of recommended COVID-19 15 control measures including testing, isolation, social distancing, respiratory and 16 For peer review only 17 hand hygiene measures on risk of respiratory infection. 18 19 4. Only households with a lead householder able to speak English were able to take 20 21 part in the study up until March 2021. From March 2021, translations of the online 22 survey will be implemented for individuals recruited from this point onwards. 23 24 5. Only households of up to six people were eligible for inclusion and they were also 25 26 required to have access to an internet connection. These restrictions will limit the 27 generalisability to large or multigenerational households, and those without 28 29 access to the internet. 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 Introduction 37 38 39 The Coronavirus disease 2019 (COVID-19) pandemic has caused millions of deaths

40 on September 29, 2021 by guest. Protected copyright. 41 and impacted lives around the world with the closure of schools, workplaces, and 42 limitations on freedom of movement. Vaccines and effective scalable treatments for 43 44 COVID-19 have been developed and whilst these are rolled out across England and 45 46 Waleswe will need to rely on other measures to stop the spread of COVID-19. We will 47 also require studies to examine their long-term effectiveness as they are implemented 48 49 across England and Wales. 50 51 Governments, including those of the UK devolved nations, are adopting a wide range of 52 53 control measures to limit the spread of infection. These include isolation of people with 54 COVID-19 symptoms and their household contacts, widespread testing and contact 55 56 tracing, digital contact tracing using mobile phone apps, broad social distancing 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 measures, and local control measures. Environmental cleaning, hand hygiene and face 4 5 mask use are also advised. 6 7 Much of our current knowledge of COVID-19 comes from observations at the more 8 severe end of the disease spectrum, in hospitalised patients and individuals who die 9 10 having tested positive for the disease.[1–3] Although large-scale studies of prevalence 11 12 of PCR positive infection and seroprevalence have been established, there is currently 13 14 limited information on symptom profiles through the course of illness in non hospitalised 15 populations, children, social and behavioural risk factors for infection, strength and 16 For peer review only 17 duration of immunity, household and community transmission risk, and population 18 19 behaviours during periods of wellness and illness (including social contacts, use of 20 21 public spaces, testing behaviours, isolation, mask use, hand and respiratory hygiene). 22 This information can only be gathered accurately through prospective large-scale 23 24 community cohorts. Our experience of the MRC/Wellcome Flu Watch study[4,5] and 25 26 ESRC Bug Watch[6] study has allowed us to rapidly establish a national household 27 cohort study of 50,000 individuals. 28 29 Virus Watch aims to provide evidence on which public health approaches are most 30 31 likely to be effective in reducing the spread and impact of the virus and will investigate

32 http://bmjopen.bmj.com/ 33 community incidence, symptom profiles, and transmission of COVID-19 in relation to 34 population movement and behaviour. 35 36 37 38 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 8 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 4 Methods and analysis 5 6 Study design and setting 7 8 9 10 Virus Watch is a household community cohort study of acute respiratory infections in 11 12 England and Wales covering the second and potential subsequent waves of the 13 14 COVID-19 pandemic. The study period will be 1st June 2020 to 31st August 2021 . The 15 study aims to recruit 50,000 individuals, including 12,500 from minority ethnic 16 For peer review only 17 backgrounds for an online survey cohort (study 1). Nested within this larger study will be 18 19 a sub-cohort of 10,000 individuals (study 2), including 3,000 people from minority ethnic 20 backgrounds. Participants in this laboratory sub-cohort will be selected based on their 21 22 geographical distance away from one of our blood taking clinics; either a 10km radius 23 24 from a clinic in cities, or a 20km radius in rural areas. Participants will be balanced to be 25 26 representative of the UK population for sex, age and region. Figure 1 provides an 27 overview of the study design. 28 29 30 Households self-select into the study if they live in England and Wales and all members 31 of a household need to consent to take part in the study to meet our inclusion criteria

32 http://bmjopen.bmj.com/ 33 (Appendix 1). Households need to have an internet connection on a phone, tablet or 34 35 computer, email, and, up until the end of November 2020, at least one adult household 36 37 member that can read English. From March 2020 onwards, online surveys will be 38 39 translated into multiple languages. A household is defined as one or more people (not

40 necessarily related) whose usual residence (4 days/week or more) is at the same on September 29, 2021 by guest. Protected copyright. 41 42 address. These householders share cooking facilities, a living room or sitting room or 43 44 dining area. 45 46 47 48 49 Primary outcomes 50 51 52 Study 1: Online Survey Cohort 53 54 1. Incidence of respiratory infection symptoms, including COVID-19 disease case 55 definitions. 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 9 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 2. Effectiveness and impact of recommended COVID-19 control measures including 4 5 testing, isolation, social distancing, respiratory and hand hygiene measures on 6 7 risk of respiratory infection. 8 3. Frequency of adherence with public-health recommendations for these control 9 10 measures. 11 12 4. Proportion of community infections that result in hospital admissions and death. 13 14 5. Vaccine effectiveness against asymptomatic and symptomatic infections. 15 16 For peer review only 17 18 19 Study 2: Laboratory testing sub-cohort 20 21 1. Incidence of PCR confirmed COVID-19. 22 2. Incidence of PCR confirmed COVID-19 in those with non-respiratory 23 24 presentations. 25 26 3. Incidence of hospitalisation among PCR confirmed COVID-19 cases. 27 28 4. Proportion of individuals with SARS-CoV-2 antibodies acquired through natural 29 infection to pandemic coronavirus. 30 31 5. Proportion of individuals with cross-reacting antibodies to seasonal

32 http://bmjopen.bmj.com/ 33 coronaviruses acquiring (or not) SARS-CoV-2. 34 35 6. Household secondary attack rates. 36 7. Protective effect of antibodies on infection and re-infection as well as the severity 37 38 and spectrum of presentation. 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 Recruitment 44 45 46 We will use the Royal Mail Post Office Address File to generate a list of residential 47 48 address lists from which households can be sampled and sent Virus Watch recruitment 49 postcards to. The proposed initial sample design is a single-stage stratified probability 50 51 sample where implicit stratification is employed to benefit from the precision gains that 52 53 stratified sampling can bring. Within each region, residential addresses are sorted by (a) 54 55 quintiles of Index of Multiple Deprivation 2019 (IMD), (b) within quintiles by Local 56 Authorities, (c) postcodes and (d) address. We will perform this in the nine Government 57 58 Office Regions of England as well as Wales (10 study regions in total). 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 10 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 4 5 We will assess recruitment rates and the representativeness of this initial sample 6 7 following the mail out of 50,000 postcards. If recruitment is lower than expected or 8 under-representative of the national population, we will redesign our recruitment 9 10 campaign to include a range of methods in order to build the cohort. This mixed 11 12 recruitment strategy will be flexible and use a variety of methods including social media, 13 14 study leaflet drops, text messaging, personalised letters and incentives. Social media 15 adverts will be used to inform individuals about the study and direct them to our website 16 For peer review only 17 http://ucl-virus-watch.net/ where they can read the participant information sheets and 18 19 consent to taking part. Digital invitations will also be created for sharing via WhatsApp. 20 21 Text messages and postal letters inviting patients from their General Practitioner clinics 22 will be organised via Local Clinical Research Networks.[7] We will also work with trusted 23 24 community partners and religious organisations to promote recruitment into the study. 25 26 27 In order for a household to be enrolled, they will require an internet connection (Wi-Fi, 28 29 fixed or on a mobile phone), email address, and all household members must agree to 30 31 take part. Households will nominate a lead householder who will submit study

32 http://bmjopen.bmj.com/ 33 questionnaires. Up until March 2021, the lead householder will need to be able to read 34 English to support other household members in survey completion. From March 2021 35 36 onwards, online surveys will be translated into multiple languages and this will no longer 37 38 be an inclusion criteria. A household is defined as one or more people (not necessarily 39 related) whose usual residence (4 days/week or more) is at the same address. These

40 on September 29, 2021 by guest. Protected copyright. 41 householders share cooking facilities, and may share a living room or sitting room or 42 43 dining area if available. Households with more than six members will not be eligible for 44 45 the study - this criteria was set due to limitations of the REDCap survey infrastructure 46 which did not function correctly when attempting to work with household sizes of greater 47 48 than six during our pilot testing of the survey. 49 50 51 52 Virus Watch is powered for our primary aims in study 2 and the estimation of 53 population-level symptomatic COVID-19 attack rate over time. Recruiting a cohort that 54 55 is representative of the population is time consuming as it requires an initial invitation 56 57 into a study followed by multiple follow-up contacts encouraging invited individuals to 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 11 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 register. Given the urgency of the public health situation to roll out our study as quickly 4 5 as possible we chose a different approach whereby we recruit a large cohort of 50,000 6 7 individuals and from within that cohort we select a sub-sample for the testing cohort 8 (sub-cohort 1) which is representative of the population in terms of age, sex, ethnicity, 9 10 region, household size and proportion of households with children. The larger cohort 11 12 will be important in assessing rates and predictors of less frequent outcomes such as 13 14 hospitalisation and death. Given recent information of marked ethnicity differences in 15 mortality rates from COVID-19 we also chose to recruit an ethnicity sample designed to 16 For peer review only 17 be sufficiently large to provide early indicators of whether these differential mortality 18 19 rates are due to differences in disease incidence or in differences in severity or both. 20 21 22 23 Power Analysis 24 25 26 The testing sub-cohort is powered for accurate weekly age-specific disease incidence 27 rates to be measured assuming 20-30% clinical attack rate over 18 weeks. With a 28 29 clinical attack rate of 30% of whom 20% need hospitalisation, and 0.5% die we expect 30 31 the following number of outcome events in our testing cohort of 10,000 individuals in

32 http://bmjopen.bmj.com/ 33 study 2: 3000 COVID-19 illnesses, 600 hospitalised cases, and 15 deaths. At one 34 month into the outbreak we would be able to detect a 1.7-fold greater risk of disease in 35 36 a population subgroup that constitutes 1/5 of the population, and by 2 months the 37 38 detectable relative risk would be only 1.2. At one month we could detect a 4% hospital 39 admission rate amongst cases with 95% CI of 0.5-6.8, and by 2 months the confidence

40 on September 29, 2021 by guest. Protected copyright. 41 intervals would narrow to 3.1-4.1. We have used estimates of the expected number of 42 43 events over time to provide an indication of the fact that the cohort is sufficiently large to 44 45 provide valuable information through the course of the pandemic. Sample size 46 calculations have been informed by a realistic assessment of what we can achieve 47 48 based on our previous experience[4,6]. For the serology cohort of 3000 people from 49 50 minority ethnic backgrounds we assume a modest design effect (DE) due to household 51 and geographical clustering, and 500 participants for six different minority ethnic 52 53 backgrounds would enable the measurement of a cumulative incidence of 10% with 54 55 95% confidence intervals of 3% by each minority ethnic group. 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 12 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Participant materials and incentives 4 5 6 7 8 Participant information sheets will be held on our study website (these along with 9 consent forms were translated into 6 languages and a further 3 languages were added 10 11 from December 2020). In order to participate, the whole household must take part. 12 13 Each adult participant will need to read through study information, and provide online 14 informed consent for themselves and any children they are legally responsible for. 15 16 Children aged 6-9For and 10-15 peer years respectively review will also only be asked to read through age 17 18 specific study participant information sheets and provide online informed assent. For 19 20 children aged 5 and under, parents/guardians will consent on their behalf. Informed 21 consent data will be securely stored in UCL’s Data Safe Haven which has been certified 22 23 to the ISO27001 information security standard and conforms to NHS Digital's Data 24 25 Security and Protection Toolkit. Local study teams will re-consent participants face to 26 face, prior to undertaking blood sampling, and adult participants in study 2 will be 27 28 offered a £10 voucher to reimburse travel costs. From February 2021, invitation letters 29 30 sent by GP clinics will include a £20 voucher for households that agree to take part in 31 the study.

32 http://bmjopen.bmj.com/ 33 34 Data collection and follow-up 35 36 37 38 Study 1: Online Survey Cohort 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 The online survey cohort will collect data and follow up participants through six different 43 sources. Survey data will be collected using Research Electronic Data Capture 44 45 (REDCap) electronic data capture tools hosted on the UCL Data Safe Haven (Appendix 46 47 2, Appendix 3, Appendix 4).[8] REDCap is a secure, web-based application for research 48 studies. The UCL Data Safe Haven provides a technical solution for storing, handling 49 50 and analysing identifiable data. It has been certified to the ISO27001 information 51 52 security standard and conforms to NHS Digital’s Data Security and Protection Toolkit . 53 54 55 1) Baseline Survey. The 56 57 Lead Householder will be asked to complete an online baseline survey for each 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 13 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 member of their household. Information collected includes: demographics, occupation, 4 5 income, ethnicity, country of birth, year of entry to UK, chronic medical conditions, 6 7 medications, pregnancy status, vaccines, mode of transport to work, any previous 8 contact with someone with COVID-19, previous symptoms of COVID-19-like illness and 9 10 infection-prevention behaviours such as social distancing and hand hygiene. 11 12 13 14 2) Illness Surveys. 15 Participants will be followed-up weekly via an email with a link to an illness survey. This 16 For peer review only 17 is a weekly survey of the presence or absence of symptoms that could indicate COVID- 18 19 19 disease including respiratory, general infection symptoms or gastrointestinal 20 21 symptoms. During illness, prospective daily symptom recording, quality of life, health 22 seeking behaviour (NHS 111, GP in person, GP by phone, A&E, Pharmacy, Hospital), 23 24 treatments, and NHS investigations will be recorded. This survey will also include any 25 26 respiratory and hand hygiene measures, self-isolation, activities and social contact, 27 travel and face mask use. Questions around behavioural interventions, such as mask 28 29 wearing and social distancing, aim to reflect the context and frequency/degree to which 30 31 behaviours are practiced according to governmental and public health guidelines and

32 http://bmjopen.bmj.com/ 33 relevant scientific literature. The survey includes questions to the household on 34 activities undertaken in the week prior to symptom onset. The weekly survey will also be 35 36 used to capture test results received from outside the study and requests to self isolate 37 38 eg. via the UK Test-Trace-Isolate system. The weekly survey will also ask about 39 participants’ COVID-19 vaccination uptake, including their date of vaccination, dose (i.e.

40 on September 29, 2021 by guest. Protected copyright. 41 first or second), and which vaccine was administered. 42 43 44 45 3) Monthly Surveys. A 46 number of questions will be asked every month. The monthly surveys also provide 47 48 flexibility to ask additional questions (eg. behavioural changes) to reflect any new 49 50 government directives on social distancing, testing, contact tracing, and vaccine 51 52 delivery. Core questions will also allow us to follow up reasons for any non-response in 53 a given month- (e.g. because of illness, hospitalisation or holiday). We will also ask 54 55 about online health information seeking, social distancing, including recent (week 56 57 before) contacts, activities, places visited and hand & respiratory hygiene. As with the 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 14 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 weekly questionnaire, questions around behavioural practices will reflect governmental 4 5 and public health guidelines and the scientific literature; monthly questionnaires will also 6 7 investigate barriers and enablers to health-related behaviours using purpose-developed 8 questionnaires based on the Capability, Motivation, Opportunity, Behaviour (COM-B) 9 10 model. We will also ask about finances, employment, and mental health to see how the 11 12 COVID-19 response is affecting participants’ wellbeing and ability to work. We will ask 13 14 about access to healthcare for non–COVID-19 health problems to explore the indirect 15 health impacts of the pandemic. We will ask about any COVID-19 PCR or antibody test 16 For peer review only 17 results performed outside the study and not already reported through baseline surveys. 18 19 We will ask about influenza vaccine uptake and COVID-19 vaccination intentions. 20 21 22 4) Data Linkage. NHS 23 24 Digital will undertake quarterly data linkage between cohort 1 and Hospital Episode 25 26 Statistics (HES), which includes admitted patient and critical care episodes, outpatient 27 department bookings, and emergency care contacts. This linkage will also include 28 29 Office for National Statistics mortality data, COVID-19 vaccination records, and virology 30 31 testing data routinely collected by Public Health England, Public Health Wales, and the

32 http://bmjopen.bmj.com/ 33 Department of Health and Social Care through ‘Pillar 1’ (testing in hospital patients and 34 health and care workers) and ‘Pillar 2’ (community testing). These data sources will be 35 36 linked to the cohort using name, NHS numbers, dates of birth and postal address. 37 38 Identifying variables will be removed before the linked data are transferred back to UCL 39 for analysis. These data linkages will continue for up to 5 years after the end of the

40 on September 29, 2021 by guest. Protected copyright. 41 study as we anticipate COVID-19 will become a recurring winter infection and we wish 42 43 to understand its impact on health services in subsequent years. These linkage studies 44 45 will identify any participants that have been admitted to hospital or died due to causes 46 that could be directly or indirectly linked to the COVID-19 pandemic. Indirect causes 47 48 include those related to limitations in healthcare access during the pandemic. 49 50 Reductions in the use of routine health services will also be monitored via linkage to 51 52 HES data. 53 54 55 5) Geo-location Tracking. 56 57 All adult participants will be asked about optional consent to use a secure geo-location 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 15 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 tracking app (Tracker for ArcGIS) installed on their mobile phone for the duration of the 4 5 study. 6 7 8 6) Monthly antibody testing using home finger prick kits. Adults aged 18 years and 9 10 over enrolled in the online survey cohort, with the exception of those in laboratory 11 12 testing sub-cohort Group 3, will be offered monthly antibody testing starting from 13 14 February 2021 and continuing until the end of the study, using home finger prick kits for 15 self-collection of capillary blood samples. Those aged under 18 and living with adults 16 For peer review only 17 enrolled in monthly antibody testing will continue completing online surveys. Monthly 18 19 antibody testing (February-August 2021) will utilise CE-marked at home finger prick kits 20 21 designed to collect small-volume (400-600 microlitres) capillary blood samples. 22 Samples are self-collected by adult participants and returned to a UKAS-accredited 23 24 laboratory via pre-paid post, where they will be tested for anti-Nucleocapsid and anti- 25 26 Spike antibodies using validated electro-chemiluminescence immunoassays. 27 28 29 Study 2: Laboratory testing sub-cohort 30 31

32 http://bmjopen.bmj.com/ 33 All participants agreeing to take part in the main cohort (study 1) will be asked to 34 35 provide consent to be contacted and invited to participate in one of the three laboratory 36 testing sub-groups. This will enable a cohort of 10,000 individuals selected from the 37 38 main cohort of 50,000 individuals to be maximally representative of the population of 39 England and Wales. All participants taking part in study 2 will be asked to use the 40 on September 29, 2021 by guest. Protected copyright. 41 42 national test, trace and isolation system in addition to providing samples as part of Virus 43 Watch. 44 45 46 47 Study 2 will consist of three groups that will follow different schedules of antibody testing 48 and nasal/throat swabs for PCR testing. 49 50 51 52 Group 1 (n=7000): 53 54 With data from this group we aim to identify infection in those with a wide range of 55 respiratory symptoms. Participants will be asked to submit a nose/throat swab if they 56 57 experience two consecutive days of: fever (>37.8), feeling feverish, or new persistent 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 16 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 cough, or loss or altered sense of smell or taste (COVID-19 suspected case definition), 4 5 or shortness of breath, or ear pain or change in hearing, or sore throat, or sneezing, or 6 7 blocked nose, or runny nose, or wheeze or sinus pain or congestion (other respiratory 8 manifestations). 9 10 11 12 Group 2 (n=1000): 13 14 This group aims to identify the importance of non-respiratory presentations. Participants 15 will be asked to submit a self-taken nasal/throat swab for PCR identification of COVID- 16 For peer review only 17 19 and other respiratory viruses if: 18 19 ● Either - two consecutive days of respiratory symptoms (e.g. cough, runny nose, 20 21 sneezing, shortness of breath, sore throat, blocked nose, sinus pain or 22 congestion, ear pain or change in hearing, wheezing, loss of or altered sense of 23 24 taste or sense of smell). 25 26 ● OR – two consecutive days of gastrointestinal symptoms (e.g. diarrhoea/loose 27 stools, abdominal pain, nausea or vomiting, loss of appetite). 28 29 ● OR - two consecutive days of general infection symptoms (e.g. feeling feverish, 30 31 having a high temperature, feelings of severe unexplained tiredness, generalised

32 http://bmjopen.bmj.com/ 33 muscle or joint aches) 34 35 36 Group 3 (n = 2000): 37 38 This group aims to identify the extent of household transmission. Participants will be 39 asked to submit a nose/throat swab if they experience two consecutive days of cough or

40 on September 29, 2021 by guest. Protected copyright. 41 fever or loss of sense of taste or smell. Household contacts of the index case will also 42 43 be asked to submit a swab on the same day whether or not they have symptoms. 44 45 46 If any of the swabs indicate SARS-COV-2 infection, all household members will be 47 48 asked to repeat the swab on Day 7 and Day 14. If there are no new SARS-COV-2 49 50 cases in the household arising from swabs on Day 7 and 14 (assumed secondary 51 52 cases) then all household members will be asked to undertake a home finger prick 53 antibody test on Day 21. If there is one or more secondary cases in the household then 54 55 the entire household will be asked to take an additional swab on day 21 and then 56 57 undertake the fingerprick antibody tests on Day 28. 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 17 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 4 5 End of follow-up 6 7 8 9 Online participant follow-up will end in August 2021 for households enrolled in monthly 10 antibody testing, and in May 2021 for others, although, depending on the progression of 11 12 COVID-19, we may ask participants to continue in the study for longer. Participants will 13 14 be sent an exit survey. Participants will be contacted to arrange a second blood sample 15 16 collection from AprilFor 2021. Follow-uppeer through review data linkage only with Hospital Episode 17 Statistics, COVID-19 vaccination records, and Mortality data will continue for 5 years 18 19 after the end of the study. 20 21 22 Laboratory testing 23 24 Antibody testing 25 26 27 Study 2 will be using two different types of antibody tests. First, full blood serology will 28 29 be taken between October 2020 and January 2021. We will use experienced health 30 31 care professionals, including research nurses from the NIHR Clinical Research

32 Networks.[9] Depending on local circumstances, visits to participants’ homes to take http://bmjopen.bmj.com/ 33 34 blood may also be arranged. Children aged 15 years or less can opt out of having their 35 36 blood taken but will be offered a finger prick antibody test conducted by a healthcare 37 worker instead. All participants from laboratory group 3 will additionally be offered a 38 39 finger prick antibody test at the same time as blood taking. From April 2021 until July

40 on September 29, 2021 by guest. Protected copyright. 41 2021, we will invite all participants back for full blood tests or, for children who do not 42 43 wish to have a full bleed, healthcare worker-delivered finger prick based antibody tests. 44 45 46 Families of children who have not been able to attend for a blood test, or for a 47 48 healthcare worker-delivered finger prick antibody test, will be provided with postal kits to 49 perform these at home. We also plan to use finger prick antibody testing where local 50 51 clinics are no longer able to undertake full blood tests due to COVID-19 travel 52 53 restrictions. Extremely clinically vulnerable participants will be sent home fingerprick 54 55 tests instead of being asked to provide a serological sample. 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 18 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Virus detection 4 5 6 Participants will post swab samples for PCR assays of COVID-19, and subsequent 7 testing for influenza virus, seasonal coronavirus, rhinovirus and respiratory syncytial 8 9 virus (RSV). When COVID-19 is identified we will also undertake whole genome 10 11 sequencing of the virus. Samples for COVID-19 diagnostics will be handled and 12 processed according to the NHS and UCL guidance on sample handling during the 13 14 COVID-19 pandemic. 15 16 For peer review only 17 18 COVID-19 PCR and serology results will be returned to participants via email message 19 systems. These messages will include links to official support, information and advice 20 21 from NHS and PHE as well as advice on how to interpret results based on current 22 23 evidence. In laboratory group 3, where positive test results will trigger further testing of 24 25 the household, the results email will also include details explaining the additional testing 26 requests. We be not asking for inconclusive COVID-19 PCR results to be repeated 27 28 29 30 Statistical analysis 31

32 http://bmjopen.bmj.com/ 33 34 Our primary analyses during the winter 2020/21 will focus on estimating age-specific 35 36 weekly rates of symptoms and risk factors for PCR-confirmed COVID-19 illness and 37 38 hospitalisation. For these analyses we will use poisson regression models that account 39 for clustering by household using robust standard errors and we will explore the use of

40 on September 29, 2021 by guest. Protected copyright. 41 stratification or weighting of the sample by age and region as necessary to give 42 43 nationally representative estimates. Weekly rates will be expressed per 100,000 44 45 person-weeks for ease of comparison with national surveillance data. 46 47 48 We will examine the proportion of the population infected during the first wave (e.g. Feb 49 50 2020 to Sept 2020) and second and potentially future pandemics waves. We will 51 estimate the percentage of the population infected by calculating age and wave-specific 52 53 rates of serological infection and PCR-confirmed disease per 100 person-seasons using 54 55 poisson regression with robust standard errors to account for household-level 56 57 clustering. A person-season will be defined by the epidemic curve in the cohort and 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 19 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 therefore rates will account for differential follow-up time during each epidemic peak. In 4 5 these analyses we will examine risk factors for infection, disease, disease severity and 6 7 disease transmission. 8 9 10 We will estimate the proportion of serologically confirmed SARS-CoV-2 infections 11 12 leading to symptomatic disease. First, we will calculate age-adjusted attributable rates 13 14 of illness due to infection (subtracting rates of respiratory illness in non seroconverters 15 from those in seroconverters). Second, we will measure the proportion of 16 For peer review only 17 seroconverters with PCR-confirmed COVID-19. Analyses plans will be developed prior 18 19 to conducting all analyses. 20 21 22 We will estimate vaccine effectiveness against asymptomatic SARS-CoV-2 infections 23 24 and against symptomatic COVID-19 using anti-Nucleocapsid seroconversion, positive 25 26 PCR testing, and self-reported symptoms data. We will utilise both time-to-event and 27 test-negative analytical frameworks. Using quantitative antibody data, we will assess the 28 29 dynamics of anti-spike antibodies over time and the relationship between antibody titres 30 31 and the risk of infection.

32 http://bmjopen.bmj.com/ 33 34 Whilst the study is being conducted, we will produce early, preliminary results and 35 36 analyses for participants, the general public, government scientific advisory groups and 37 38 policy makers in order to inform the public health response to the pandemic. These 39 analyses will be reactive to the epidemiological circumstances and are therefore not

40 on September 29, 2021 by guest. Protected copyright. 41 defined in this protocol. 42 43 44 45 Modelling 46 47 We will build on our experience of working with PHE, Google, and Microsoft to use 48 49 anonymous national or subnational aggregate web search engine data[10,11] to monitor 50 the spreading of the disease. We will use our study data as ground-truth to train real- 51 52 time disease prevalence estimation algorithms. We will annotate GPS tracking data into 53 54 standard categories including time at work and home, social venues, supermarkets, 55 56 hospitals, GPs, and transport mode for incorporation in classical epidemiological 57 analyses. Integrating the linked survey data, we will develop a predictive spatio- 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 20 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 temporal transmission model to investigate the impact of various social distancing 4 5 strategies. 6 7 8 9 Missing data 10 11 12 13 14 We have several strategies that attempt to address the issue of missing data. First, we 15 have sought to minimise the amount and impact of missing data for key outcomes and 16 For peer review only 17 exposures through the study design. For example, for a number of our primary 18 19 outcomes (PCR+ illness, hospitalisation and death) and exposures (vaccination) we 20 collect data both as self-reported and through data linkage with the relevant national 21 22 datasets and registries. Second, we sought to minimise missing serological and virus- 23 24 watch specific swabbing outcomes in adults by making willingness to provide relevant 25 26 specimens a prerequisite to study registration. Third, we know from our experience of 27 previous community cohort studies of acute infections (Flu Watch[4] and Bug Watch[6]) 28 29 that response to weekly surveys (where our symptom data is collected) is high at 30 31 around 75%, which we believe is achieved by keeping these weekly data collections

32 http://bmjopen.bmj.com/ 33 simple and quick to complete. We have aimed to replicate this approach in Virus Watch. 34 Forth, for important missing baseline demographic data (e.g. age and sex) we have 35 36 created follow-up surveys to try and collect missing data at a later time in time. Fifth, 37 38 where necessary, we will address missing data in our analyses and use multiple 39 imputation methods if appropriate.

40 on September 29, 2021 by guest. Protected copyright. 41 42 Patient and Public Involvement 43 44 Due to the urgent nature of this study, we did not involve participants in its original 45 46 design. We have previously conducted PPI to support similar community cohort studies 47 48 of acute infections using similar methodologies. We have engaged the Young Persons' 49 50 Advisory Group for research at Great Ormond Street Hospital to provide feedback on 51 our Children's Participant Information Sheets. We have worked with the Race Equality 52 53 Foundation and Doctors of the World in advising on the inclusion of people from 54 55 minority ethnic backgrounds in Virus Watch and have set up an advisory group to inform 56 57 the ongoing design and dissemination of health equity aspects of Virus Watch. They 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 21 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 were not asked to assess the burden of the intervention and time required to participate 4 5 in the research due to the urgent nature of setting the study up. This advisory group 6 7 (consisting of lay members of the public, community leaders, charities and policy 8 organisation) will guide our health equity analyses and steer us on its implications for 9 10 people, communities and policy. The advisory group will also help us prioritise what 11 12 information and results to share, when, and in what format. 13 14 15 16 Ethics and disseminationFor peer review only 17 18 19 This is a national study that has been approved by the Hampstead NHS Health 20 21 Research Authority Ethics Committee. Ethics approval number – 20/HRA/2320. The 22 23 study is compliant with the requirements of General Data Protection Regulation 24 25 (2016/679) and the Data Protection Act (2018). All investigators and study site staff will 26 comply with the requirements of the General Data Protection Regulation (2016/679) 27 28 with regards to the collection, storage, processing and disclosure of personal 29 30 information, and will uphold the Act’s core principles. 31

32 http://bmjopen.bmj.com/ 33 We will provide opportunities for survey participants to comment on survey methodology 34 35 at the first monthly survey and consider revisions based on this. We are also monitoring 36 37 participant queries through our study email address and using these to refine 38 methodology where necessary. 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 Data sharing and access 44 45 46 We aim to share aggregate data from this project on our website and via a “Findings so 47 48 far” section on our website - https://ucl-virus-watch.net/. We will also be sharing 49 50 individual record level data with personal identifiers removed on a research data sharing 51 52 service such as the Office of National Statistics Secure Research Service.[12] In 53 sharing the data we will work within the principles set out in the UKRI Guidance on best 54 55 practice in the management of research data.[13] Access to use of the data whilst 56 57 research is being conducted will be managed by the Chief Investigators (ACH and 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 22 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 RWA) in accordance with the principles set out in the UKRI guidance on best practice in 4 5 the management of research data. It is the intention that the data arising from this 6 7 research will initially be collected, cleaned and validated by the UCL research team and 8 once this has been completed will be shared for wider use. We aim to make subsets of 9 10 the data more rapidly available both on our study website and via the public facing 11 12 dashboard during the ongoing phase of data collection. In line with Principle 5 of the 13 14 UKRI guidance on best practice in the management of research data, we plan to 15 release data in batches as they become available or as updated results are published. 16 For peer review only 17 Individual record data linked using NHS Digital will not be shared, only aggregated 18 19 results. HES and mortality data may be obtained from a third party and are not publicly 20 21 available. These data are owned by a third party and can be accessed by researchers 22 applying to the Health and Social Care Information Centre for England. We will put 23 24 analysis code on publicly available repositories to enable their reuse. 25 26 27 28 29 Author Contributions 30 31

32 Roles: Conceptualization (AH, EF, JK, PH, EN, BK, IC, VL, RAMcK, TC, AMJ, SM, JG, http://bmjopen.bmj.com/ 33 RG, AR, RWA) Investigation, Methodology (All authors), Project Administration (AH, EF, 34 JK, VN, SB, TB, AA, PH, LW, WLEF, CG, PP, MSh, AMDN, EN, MSp, RWA) , Writing – 35 Original Draft Preparation (All Authors), Software (VN, TB, SB, RWA), Resources (AH, 36 EF, JK, PH, EN, BK, IC, VL, RAMcK, TC, YL, AMJ, SM, JG, RG, AR, RWA), Writing – 37 38 Review & Editing (All Authors). 39

40 on September 29, 2021 by guest. Protected copyright. 41 42 43 44 Funding 45 46 The research costs for the study have been supported by the MRC Grant Ref: MC_PC 47 48 19070 awarded to UCL on 30 March 2020 and MRC Grant Ref: MR/V028375/1 49 50 awarded on 17 August 2020. The study also received $15,000 of Facebook advertising 51 52 credit to support a pilot social media recruitment campaign on 18th August 2020. 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 23 of 80 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Competing interests: ACH serves on the UK New and Emerging Respiratory Virus 4 5 Threats Advisory Group. AMJ was a Governor of Wellcome Trust from 2011-18 and is 6 7 Chair of the Committee for Strategic Coordination for Health of the Public Research. 8 9 10 Figure legends 11 12 13 14 Figure 1. Overview of cohort recruitment, PCR swabbing schedules and data collection 15 16 for the Virus WatchFor household peer community review cohort study. only 17 18 19 20 21 22 References 23 24 25 26 27 28 1 Official UK Coronavirus Dashboard. https://coronavirus.data.gov.uk/ (accessed 30 Nov 29 2020). 30 31 2 Statistics. Statistics » COVID-19 Daily Deaths. https://www.england.nhs.uk/statistics/statistical-work-areas/covid-19-daily-deaths/ 32 http://bmjopen.bmj.com/ 33 (accessed 30 Nov 2020). 34 35 3 Coronavirus (COVID-19). 36 https://www.ons.gov.uk/peoplepopulationandcommunity/healthandsocialcare/conditionsand 37 diseases (accessed 30 Nov 2020). 38 39 4 Fragaszy EB, Warren-Gash C, Wang L, et al. Cohort Profile: The Flu Watch Study. Int J

40 Epidemiol 2017;46:e18. doi:10.1093/ije/dyv370 on September 29, 2021 by guest. Protected copyright. 41 42 5 Hayward AC, Fragaszy EB, Bermingham A, et al. Comparative community burden and 43 severity of seasonal and pandemic influenza: results of the Flu Watch cohort study. Lancet 44 Respir Med 2014;2:445–54. doi:10.1016/S2213-2600(14)70034-7 45 46 6 Smith CM, Conolly A, Fuller C, et al. Symptom reporting, healthcare-seeking behaviour and 47 antibiotic use for common infections: protocol for Bug Watch, a prospective community 48 cohort study. BMJ Open 2019;9:e028676. doi:10.1136/bmjopen-2018-028676 49 50 7 Clinical Research Network. https://www.nihr.ac.uk/explore-nihr/support/clinical-research- 51 network.htm (accessed 30 Nov 2020). 52 53 8 Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)--a 54 metadata-driven methodology and workflow process for providing translational research 55 informatics support. J Biomed Inform 2009;42:377–81. doi:10.1016/j.jbi.2008.08.010 56 57 9 Clinical Research Network. https://www.nihr.ac.uk/explore-nihr/support/clinical-research- 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 24 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 network.htm (accessed 30 Nov 2020). 4 5 10 Wagner M, Lampos V, Cox IJ, et al. The added value of online user-generated content in 6 traditional methods for influenza surveillance. Sci Rep 2018;8:13963. doi:10.1038/s41598- 7 018-32029-6 8 9 11 Lampos V, Majumder MS, Yom-Tov E, et al. Tracking COVID-19 using online search. arXiv 10 [cs.SI]. 2020.http://arxiv.org/abs/2003.08086v10 11 12 12 Accessing secure research data as an accredited researcher. 13 https://www.ons.gov.uk/aboutus/whatwedo/statistics/requestingstatistics/approvedresearch 14 erscheme (accessed 12 Mar 2021). 15 16 13 UKRI. GuidanceFor on best peerpractice in the review management of onlyresearch data. 17 https://www.ukri.org/wp-content/uploads/2020/10/UKRI-020920- 18 GuidanceBestPracticeManagementResearchData.pdf 19 20 21 22 23 24 25 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

1 2 3

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 26 of 80 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 1 2 3 Appendix 1 - Study inclusion and exclusion criteria: 4 5 6 Inclusion: 7 ● Households self-select into the study. 8 ● Participants need to join as a household (all must take part). 9 ● They need to have internet connection on a phone, tablet or computer, email and up 10 11 until end of Feb 2021 at least one adult that can read English. 12 ● From December 2020, online surveys will be translated into multiple languages. 13 14 Exclusion Criteria 15 We will exclude participants if: 16 For peer review only 17 ● Number of householders exceeds 6. 18 ● Those without internet connection on a phone, tablet or computer, or an email address 19 available to them as they will be unable to register 20 ● There is no adult in the household who can read English (from March 2021 this will no 21 longer be an exclusion criteria) 22 23 ● A household is defined as one or more people (not necessarily related) whose usual 24 residence (4days/week or more) is at the same address. These householders share 25 cooking facilities, a living room or sitting room or dining area. 26 27 28 29 30 31

32 http://bmjopen.bmj.com/ 33 34 35 36 37 38 39

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 Baseline Survey for [hh1_fname] [hh1_sname] 7 alive 8 ______9 10 11 The baseline survey collects some basic information about each person participating in Virus Watch. We will ask 12 about each household member in turn, please ask each adult to complete their own information and help children to 13 complete their sections or complete them for them 14 15 [hh1_fname] [hh1_sname]: At birth you were described Male 16 as? Female 17 Intersex 18 For peer reviewPrefer only not to say 19 20 [hh1_fname] [hh1_sname]: Do you know your NHS Number? Yes 21 This can usually be found on an NHS letter No 22 23 24 [hh1_fname] [hh1_sname]: What is your NHS Number? ______25 26 27 [hh1_fname] [hh1_sname]: Where is your place of Birth? United Kingdom 28 Other 29 30 [hh1_fname] [hh1_sname]: When did you first come to 31 live in the UK (approximately)? ______32 DD/MM/YYYY 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 [hh1_fname] [hh1_sname]: Please specify where you were Afghanistan 2 born: Albania 3 Algeria 4 American Samoa BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Andorra 6 Angola 7 Anguilla 8 Antarctica 9 Antigua And Barbuda 10 Argentina 11 Armenia 12 Aruba 13 Australia 14 Austria 15 Azerbaijan Bahamas 16 Bahrain 17 Bangladesh 18 For peer reviewBarbados only 19 Belarus 20 Belgium 21 Belize 22 Benin 23 Bermuda 24 Bhutan 25 Bolivia 26 Bosnia And Herzegovina 27 Botswana 28 Bouvet Island 29 Brazil 30 British Indian Ocean Territory 31 Brunei Darussalam 32 Bulgaria Burkina Faso 33 Burundi 34 Cambodia 35 Cameroon 36 Canada http://bmjopen.bmj.com/ 37 Cape Verde 38 Cayman Islands 39 Central African Republic 40 Chad 41 Chile 42 China 43 Christmas Island 44 Cocos (keeling) Islands on September 29, 2021 by guest. Protected copyright. 45 Colombia 46 Comoros 47 Congo 48 Congo, The Democratic Republic Of The 49 Cook Islands 50 Costa Rica Cote D'ivoire 51 Croatia 52 Cuba 53 Cyprus 54 Czech Republic 55 Denmark 56 Djibouti 57 Dominica 58 Dominican Republic 59 East Timor 60 Ecuador Egypt El Salvador Equatorial Guinea For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtmlEritrea Estonia 12/03/2021 1:10pm Ethiopia projectredcap.org Page 29 of 80 BMJ Open Falkland Islands (malvinas) Faroe Islands 1 Fiji 2 Finland 3 France 4 French Guiana BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 French Polynesia 6 French Southern Territories 7 Gabon 8 Gambia 9 Georgia 10 Germany 11 Ghana 12 Gibraltar 13 Greece 14 Greenland 15 Grenada Guadeloupe 16 Guam 17 Guatemala 18 For peer reviewGuinea only 19 Guinea-bissau 20 Guyana 21 Haiti 22 Heard Island And Mcdonald Islands 23 Holy See (vatican City State) 24 Honduras 25 Hong Kong 26 Hungary 27 Iceland 28 India 29 Indonesia 30 Iran, Islamic Republic Of 31 Iraq 32 Ireland Israel 33 Italy (Italian Republic) 34 Jamaica 35 Japan 36 Jordan http://bmjopen.bmj.com/ 37 Kazakstan 38 Kenya 39 Kiribati 40 Korea, Democratic People's Republic Of 41 Korea, Republic Of 42 Kosovo 43 Kuwait 44 Kyrgyzstan on September 29, 2021 by guest. Protected copyright. 45 Lao People's Democratic Republic 46 Latvia 47 Lebanon 48 Lesotho 49 Liberia 50 Libyan Arab Jamahiriya Liechtenstein 51 Lithuania 52 Luxembourg 53 Macau 54 Macedonia, The Former Yugoslav Republic Of 55 Madagascar 56 Malawi 57 Malaysia 58 Maldives 59 Mali 60 Malta Marshall Islands Martinique Mauritania For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtmlMauritius Mayotte Mexico BMJ Open Page 30 of 80 Micronesia, Federated States Of Moldova, Republic Of 1 Monaco 2 Mongolia 3 Montserrat 4 Montenegro BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Morocco 6 Mozambique 7 Myanmar 8 Namibia 9 Nauru 10 Nepal 11 Netherlands 12 Netherlands Antilles 13 New Caledonia 14 New Zealand 15 Nicaragua Niger 16 Nigeria 17 Niue 18 For peer reviewNorfolk only Island 19 Northern Mariana Islands 20 Norway 21 Oman 22 Pakistan 23 Palau 24 Palestinian Territory, Occupied 25 Panama 26 Papua New Guinea 27 Paraguay 28 Peru 29 Philippines 30 Pitcairn 31 Poland 32 Portugal Puerto Rico 33 Qatar 34 Reunion 35 Romania 36 Russian Federation http://bmjopen.bmj.com/ 37 Rwanda 38 Saint Helena 39 Saint Kitts And Nevis 40 Saint Lucia 41 Saint Pierre And Miquelon 42 Saint Vincent And The Grenadines 43 Samoa 44 San Marino on September 29, 2021 by guest. Protected copyright. 45 Sao Tome And Principe 46 Saudi Arabia 47 Senegal 48 Serbia 49 Seychelles 50 Sierra Leone Singapore 51 Slovakia 52 Slovenia 53 Solomon Islands 54 Somalia 55 South Africa 56 South Georgia And The South Sandwich Islands 57 Spain 58 Sri Lanka 59 Sudan 60 Suriname Svalbard And Jan Mayen Swaziland Sweden For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtmlSwitzerland Syrian Arab Republic Taiwan, Province Of China Page 31 of 80 BMJ Open Tajikistan Tanzania, United Republic Of 1 Thailand 2 Togo 3 Tokelau 4 Tonga BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Trinidad And Tobago 6 Tunisia 7 Turkey 8 Turkmenistan 9 Turks And Caicos Islands 10 Tuvalu 11 Uganda 12 Ukraine 13 United Arab Emirates 14 United Kingdom 15 United States United States Minor Outlying Islands 16 Uruguay 17 Uzbekistan 18 For peer reviewVanuatu only 19 Venezuela 20 VietNam 21 Virgin Islands, British 22 Virgin Islands, U.s. 23 Wallis And Futuna 24 Western Sahara 25 Yemen 26 Zambia 27 Zimbabwe 28 29 [hh1_fname] [hh1_sname]: What is your ethnic group? White - English/ Welsh/ Scottish/ Northern Irish/ 30 British 31 White - Irish 32 White - Gypsy or Irish Traveller 33 Any other white background (please describe) 34 Asian/ Asian British - Indian 35 Asian/ Asian British - Pakistani 36 Asian/ Asian British - Bangladeshi http://bmjopen.bmj.com/ 37 Asian/ Asian British - Chinese 38 Any other Asian/ Asian British background (please 39 describe) 40 Black African 41 Black Caribbean Any other Black/ African/ Caribbean background 42 (please describe) 43 Arab 44 Any other ethnic group (please describe) on September 29, 2021 by guest. Protected copyright. 45 Mixed/ multiple ethnic groups - White and Black 46 Caribbean 47 Mixed/ multiple ethnic groups - White and Black 48 African 49 Mixed/ multiple ethnic groups - White and Asian 50 Any other mixed/ multiple ethnic background 51 (please describe) 52 Prefer not to say 53 54 [hh1_fname] [hh1_sname]: Please describe your ethnic 55 group: ______56 57 58 [hh1_fname] [hh1_sname]: Are you pregnant? Yes No 59 60

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1 What trimester of pregnancy are you in? Less than 12 Weeks 2 12 Weeks to 24 Weeks 3 More than 24 weeks 4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 Contact details 7 8 [hh1_fname] [hh1_sname]: What is your mobile phone 9 number? ______10 This is so we can call you to make blood taking 11 appointments and send your test results if you are 12 selected for the swabbing part of the study. 13 If you do not have a mobile phone, please enter your 14 landline phone number, and we will seek alternative 15 arrangements to send your results if you are selected for the swabbing part of the study. 16 17 18 Address Line 1: For peer review only 19 This is to send you swabs (if you are chosen by the ______20 study team to partake in the swabbing study) 21 22 Address Line 2: 23 ______24 25 Address Line 3: 26 ______27 28 29 Post Code: 30 ______31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Medical Background for [hh1_fname] [hh1_sname] 2 3 People's health can influence the severity of COVID illness, we want to find out more about this.

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 [hh1_fname] [hh1_sname]: Please provide your general practitioner's details: 6 This will allow us to link to your information to hospital records more accurately. 7 8 Name of Surgery: 9 ______10 11 12 Address Line 1: 13 ______14 15 Address Line 2: 16 ______17 18 Address Line 3: For peer review only 19 ______20 21 22 Post Code: 23 ______24 25 [hh1_fname] [hh1_sname] : Has a doctor or other health Asthma 26 professional ever told you that you have any of the Arthritis 27 following conditions? Congestive heart failure 28 Please select all that apply. Coronary heart disease 29 Angina 30 Heart attack or myocardial infarction 31 Stroke 32 Emphysema Chronic bronchitis 33 COPD (Chronic Obstructive Pulmonary Disease) 34 Cystic fibrosis 35 Hypothyroidism or an under-active thyroid 36 Any kind of liver condition http://bmjopen.bmj.com/ 37 Cancer or malignancy 38 Insulin treated diabetes 39 Other diabetes 40 Epilepsy 41 High blood pressure/hypertension 42 An emotional, nervous or psychiatric problem 43 Multiple Sclerosis 44 HIV on September 29, 2021 by guest. Protected copyright. 45 Chronic kidney disease 46 Conditions affecting the brain and nerves, such as 47 Parkinson's disease, motor neurone disease, 48 multiple sclerosis (MS), a learning disability or 49 cerebral palsy 50 Problems with your spleen or you've had your spleen removed 51 Sickle cell disease 52 Other long standing/chronic condition 53 None of these 54 55 56 [hh1_fname] [hh1_sname]: Please specify: 57 ______58 59 60

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1 [hh1_fname] [hh1_sname]: What type of cancer or Bowel/colorectal 2 malignancy was that? Lung 3 Please select all that apply Breast 4 Prostate BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Liver 6 Skin cancer or melanoma 7 Blood or bone marrow cancer, such as leukaemia 8 Other 9 10 [hh1_fname] [hh1_sname]: What type of cancer or Bowel/colorectal 11 malignancy was that? Lung 12 Please select all that apply Breast 13 Liver 14 Skin cancer or melanoma 15 Blood or bone marrow cancer, such as leukaemia 16 Other 17 18 [hh1_fname] [hh1_sname]: HasFor a doctor peer or other health reviewAsthma only 19 professional ever told you that you have any of these Cystic fibrosis 20 conditions? Insulin treated diabetes 21 Please select all that apply Epilepsy 22 Conditions affecting the brain and nerves, such as 23 Parkinson's disease, motor neurone disease, 24 multiple sclerosis (MS), a learning disability or 25 cerebral palsy 26 Sickle cell disease 27 Other long standing/chronic condition 28 None of these 29 30 [hh1_fname] [hh1_sname] : Have you received a letter Yes 31 from the NHS, saying that "the NHS has identified you No 32 as someone at risk of severe illness if you catch 33 coronavirus, because you have an underlying disease or 34 health condition that means if you catch the virus, 35 you are more likely to be admitted to hospital than 36 others"? http://bmjopen.bmj.com/ 37 38 [hh1_fname] [hh1_sname] : Do you know your height and Yes 39 weight? No 40 41 [hh1_fname] [hh1_sname]: Do you know your height in Imperial (Feet and Inches) 42 imperial (feet and inches) or metric (centimetres)? Metric (centimetres) 43 Please select the unit you prefer if you know both 44 on September 29, 2021 by guest. Protected copyright. 45 46 [hh1_fname] [hh1_sname]: What is your height in 47 centimetres (cm)? ______48 Please enter digits only, e.g. '5' and not 'five' 49 50 [hh1_fname] [hh1_sname]: How many feet tall are you 51 (rounded down)? ______52 Please enter the feet component of your height. For 53 example if you're 5 foot 4, please enter 5 54 55 [hh1_fname] [hh1_sname]: How many inches tall are you 56 above your feet value? ______57 Please enter the inches component of your height. For 58 example if you're 5 foot 4, please enter 4 59 60

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1 [hh1_fname] [hh1_sname]: Do you know your weight in Imperial (stone and pounds) 2 imperial (stone and pounds-lbs) or metric(kilograms)? Metric (kilograms) 3 Please select the unit you prefer if you know both 4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 [hh1_fname] [hh1_sname]: How much do you weigh in 7 kilograms (kg)? ______Please enter digits only, e.g. '5' and not 'five' 8 9 10 [hh1_fname] [hh1_sname]: What is your weight in stone, 11 rounded down? ______12 For example if you are 8 stone, 10 pounds, please 13 enter 8. If you do not use stone, please feel free to 14 leave this blank and enter your weight fully in pounds 15 16 [hh1_fname] [hh1_sname]: How much do you weight in 17 pounds (lbs) (above your stone weight)? ______18 For example, if you are 8 stone,For 10 pounds, peer please review only 19 enter 10.If you did not enter a value for stone, 20 please enter your weight fully in lbs here 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 2 3

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 [hh1_fname] [hh1_sname]: Referring to the illustration 1 25 above, which body shape bests describes your body 2 26 shape? 3 27 4 28 5 29 30 HairSex hormones that affect male pattern baldness may also affect COVID severity 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 [hh1_fname] [hh1_sname]: Referring to the illustration 1 2 above, please select a number from 1-7 that best 2 3 describes your hair 3 4 4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 5 6 6 7 7 8 9 MedicationSome medicines may affect your risk of getting respiratory infections and may either protect against 10 severe diseases or possibly increase the risk. We want to find out more about this 11 12 13 [hh1_fname] [hh1_sname] : Do you take any medication? Yes 14 No 15 16 [hh1_fname] [hh1_sname]: Are you currently receiving Medication following an organ transplant 17 treatment or taking medications that may affect your Medicines such as steroid tablets that weaken the 18 immune system? For peer reviewimmune only system 19 Please select all that apply Targeted therapy or chemotherapy for cancer 20 treatment 21 Radiotherapy for cancer treatment 22 Other treatment or medication that may affect 23 immune system 24 None of these 25 26 [hh1_fname] [hh1_sname]: Do you regularly take Ranitidine (e.g. Zantac) 27 medicine to surpress gastric acid? Omeprazole (e.g. Losec) 28 Please select all that apply Antacids (e.g. Rennies) 29 None of these 30 31 [hh1_fname] [hh1_sname]: Which of the following Regularly taking Aspirin 32 medicines do you take? Regularly taking "NSAIDS" e.g. Ibuprofen, nurofen, 33 Please select all that apply diclofenic, naproxen. 34 Regularly taking blood pressure medicines ending 35 in "-pril" such as enalapril, lisinopril, 36 captopril, ramipril http://bmjopen.bmj.com/ 37 Regularly taking blood pressure measurements 38 ending in "-sartan" such as losartan, valsartan, 39 irbesartan 40 Regularly taking anticoagulants e.g warfarin, 41 ivaroxaban (Xarelto), dabigatran (Pradaxa), apixaban (Eliquis), edoxaban (Lixiana) 42 Steroid tablets 43 Regularly use a steroid inhaler 44 Regularly take statins e.g. atorvastatin (Lipitor) on September 29, 2021 by guest. Protected copyright. 45 None of these 46 47 48 [hh1_fname] [hh1_sname]: Which of the following Steroid tablets 49 medicines do you take? Regularly use a steroid inhaler 50 Please select all that apply 51 52 [hh1_fname] [hh1_sname]: Do you take any vitamin Vitamin C Supplements 53 supplements? Vitamin D Supplements 54 Please select all that apply Other 55 None 56 57 [hh1_fname] [hh1_sname]: Have you ever had a flu Yes 58 vaccine? No 59 60

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1 [hh1_fname] [hh1_sname]: Approximately when did you 2 have your most recent flu vaccine? ______3 If you do not remember the exact date, please select 4 an approximate date BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 7 Drinking and Smoking Drinking and smoking affects the risk of many diseases. We want to find out if it affects the risk of COVID-19 infection 8 9 10 [hh1_fname] [hh1_sname]: Have you ever smoked Yes 11 cigarettes regularly? No 12 13 [hh1_fname] [hh1_sname]: And do you smoke cigarettes Yes 14 at all nowadays? No 15 16 [hh1_fname] [hh1_sname]: How many cigarettes do you 17 smoke daily? ______18 Please enter digits only, e.g. '5'For and not peer 'five' review only 19 20 21 [hh1_fname] [hh1_sname]: When did you give up smoking? Less than 3 months ago 22 3 - 6 months ago 23 More than 6 months ago but less than 1 year ago 24 1 year or more ago 25 26 [hh1_fname] [hh1_sname]: Thinking about the past Daily 27 month, how often did you have a drink containing 4-6 Times per week 28 alcohol? 2-3 Times per week 29 Weekly or Less 30 2-4 times per month 31 Never 32 33 [hh1_fname] [hh1_sname]: How many drinks do you have 1-2 Drinks 34 on a typical day when you are drinking? 3-4 Drinks 35 5-6 Drinks 36 7-9 Drinks http://bmjopen.bmj.com/ 37 10+ 38 39 Accessing Health care during the lockdown 40 41 [hh1_fname] [hh1_sname]: Have you had any healthcare Yes 42 appointments cancelled, postponed or changed to a No 43 telephone or online (including video) consultation 44 since the start of the pandemic? on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Please tick all that applied I had an operation cancelled or postponed 2 I had a planned hospital admission cancelled or 3 postponed 4 I had a hospital outpatient appointment cancelled BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 or postponed 6 I had a hospital outpatient appointment changed to 7 a phone call or online (including video) 8 consultation 9 I had a GP appointment cancelled or postponed 10 I had a GP appointment changed to a phone call or 11 online (including video) consultation 12 I had another NHS appointment cancelled or 13 postponed 14 I had another NHS appointment changed to a phone 15 call or online (including video) 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Employment status for [hh1_fname] [hh1_sname] 2 3 Many people's work has been affected by the coronavirus and people's work can affect their chance of catching

4 coronavirus. We'd like to know about your work and how it has been effected by the coronavirus. BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 [hh1_fname] [hh1_sname]: Thinking back to earlier this Employed full time 7 year, before the outbreak of the coronavirus pandemic. Employed part time 8 Which of these description best describes your work Self employed full time 9 status? Self employed part time 10 Retired 11 Student 12 Looking after house/family (not looking for work) 13 Permanently sick or disabled 14 Unemployed 15 None of the above 16 17 [hh1_fname] [hh1_sname]: What is/was the name of your 18 job? For peer review______only 19 20 [hh1_fname] [hh1_sname]: Please describe what you 21 do/did at work 22 ______23 24 [hh1_fname] [hh1_sname]: Are you a health or social Yes 25 care worker? No 26 27 28 What setting do you work in? Secondary Care 29 Accident and emergency 30 Primary Care 31 Care home (residential or nursing) 32 Community Other (specify) 33 34 35 Other (Please Specify) 36 ______http://bmjopen.bmj.com/ 37 38 [hh1_fname] [hh1_sname]: Please select your Doctor 39 healthcare profession Nurse 40 Profession allied to medicine (e.g. occupational 41 therapy, physiotherapy, podiatry ) 42 Psychological Professions 43 Pharmacy 44 Midwifery on September 29, 2021 by guest. Protected copyright. 45 Healthcare science (e.g. laboratory, radiology) 46 Management 47 Porter 48 Cleaner 49 Administrative Staff with regular patient contact 50 Administrative Staff with minimal or no patient contact 51 Care Worker 52 Personal Assistant 53 Social Worker 54 Community support and outreach worker 55 Other 56 57 58 [hh1_fname] [hh1_sname]: Please specify ______59 60

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1 [hh1_fname] [hh1_sname]: What was your last job when 2 you were working? ______3

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 [hh1_fname] [hh1_sname]: Are you a healthcare student? Yes 6 e.g. medical student, student nurse No 7 8 Employment during the pandemic 9 10 [hh1_fname] [hh1_sname]: BEFORE THE PANDEMIC, how many 11 hours of paid work did you work per week? ______12 Please enter digits only, e.g. '5' and not 'five' 13 14 15 [hh1_fname] [hh1_sname]: SINCE THE PANDEMIC, during the months of March, April, May, how many hours of ______16 paid work have you worked since each week? 17 Please enter digits only, e.g. '5' and not 'five' 18 For peer review only 19 20 It looks like you have reduced your paid work during the lockdown. 21 22 [hh1_fname] [hh1_sname] : Why have you had to reduce Laid off by employer with certain recall date 23 the number of hours? Laid off or made redundant by employer with some 24 prospect of recall 25 Employer cut hours 26 Have been put on furlough or paid leave 27 Using annual leave 28 On paid or statutory sick leave 29 On unpaid sick leave 30 Caring for children or others 31 Other reasons 32 33 [hh1_fname] [hh1_sname] : Why have you had to reduce My business has been directly affected by 34 the number of hours? regulations on opening or other new regulations 35 My business has been directly affected by limited 36 supplies that I need for my business http://bmjopen.bmj.com/ 37 My business has been directly affected by reduced 38 demand for my services or products 39 Illness 40 Self-isolating 41 Caring for children or others Other reasons 42 43 44 [hh1_fname] [hh1_sname]: Have you received a written Yes on September 29, 2021 by guest. Protected copyright. 45 letter from your employer informing you that you have No 46 been furloughed under the Coronavirus Job Retention 47 scheme? 48 49 Working from home during the pandemic 50 51 [hh1_fname] [hh1_sname]: How often did you WORK FROM HOME during the following three time periods: 52 53 (Nearly) Always Often Sometimes (Almost) Never 54 Before the lockdown (before 55 March 2020) 56 57 58 59 60

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1 During the main lockdown (Mid 2 March to Mid May) when we 3 were asked to stay at Home,

4 Save Lives, Support the NHS BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 After the easing of restrictions in 7 mid-May, when we were 8 encouraged to go back to work if 9 we could not work from home 10 (Stay Alert, Control the Virus, 11 Save Lives) 12 13 14 15 [hh1_fname] [hh1_sname]: How do/did you usually travel to work? 16 Please choose one or more to represent a typical day 17 18 ForBefore peer the lockdown review (before During theonly main lockdown After the easing of 19 March 2020) (Mid March to Mid May) when restrictions in mid-May, when 20 we were asked to stay at we were encouraged to go 21 Home, Save Lives, Support back to work if we could not 22 the NHS work from home (Stay Alert, Control the Virus, Save Lives) 23 24 25 26 By car or van 27 Motorcycle, moped or scooter 28 29 Taxi or minicab 30 Train 31 32 Underground 33 Bus 34 35 Tram or light railway 36 Cycle http://bmjopen.bmj.com/ 37 Walk 38 39 Other 40 I did not travel to work during 41 this period 42 43 44 [hh1_fname] [hh1_sname]: BEFORE LOCKDOWN, how long did on September 29, 2021 by guest. Protected copyright. 45 it take to get to work each day? ______46 Please provide the time for a one-way journey in 47 minutes or enter 0 if you did not travel to work in 48 this period 49 50 [hh1_fname] [hh1_sname]: DURING LOCKDOWN, how long did 51 it take to get to work each day? ______52 Please provide the time for a one-way journey in 53 minutes or enter 0 if you did not travel to work in 54 this period 55 56 57 58 59 60

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1 [hh1_fname] [hh1_sname]: AFTER THE EASING OF 2 RESTRICTIONS, how long did it take to get to work each ______3 day? 4 Please provide the time for a one-way journey in BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 minutes or enter 0 if you did not travel to work in 6 this period 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Finances details for [hh1_fname] [hh1_sname] 2 3 Many people have been affected financially by the coronavirus. We'd like to know how you have been affected and

4 how you and your household are coping. BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 [hh1_fname] [hh1_sname]: What is your combined 0-9,999 7 household income last year? 10,000- 24,999 8 We want to understand how COVID-19 impacts households 25,000 - 49,999 9 with different levels of income 50,000 - 74,999 10 75,000 - 99,999 11 100,000 - 124,999 12 125,000 - 149,999 13 150,000 - 174,999 14 175,000 - 199,999 15 200,000 or more Prefer not to say 16 17 18 [hh1_fname] [hh1_sname] : BEFOREFor THE peer PANDEMIC, review how Living only comfortably 19 would you say you were managing financially? Would you Doing alright 20 say you were: Just about getting by 21 Finding it quite difficult 22 Finding it very difficult 23 24 [hh1_fname] [hh1_sname]: How would you say you are Living comfortably 25 managing financially now? Would you say you were: Doing alright 26 Just about getting by 27 Finding it quite difficult 28 Finding it very difficult 29 30 [hh1_fname] [hh1_sname]: BEFORE THE PANDEMIC, have you Never 31 ever needed to use a food bank? Less than once a week 32 Once a week or more 33 34 [hh1_fname] [hh1_sname]: SINCE THE PANDEMIC, have you Never 35 needed to use a food bank? Less than once a week 36 Once a week or more http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Caring information during the lockdown - [hh1_fname] [hh1_sname] 2 3 [hh1_fname] [hh1_sname]: About how many hours a week

4 did you spend on childcare or home-schooling during ______BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 the lockdown? 6 Please enter digits only, e.g. '5' and not 'five' 7 8 [hh1_fname] [hh1_sname]: Who is mainly responsible for Mainly you 9 looking after the children or home schooling? Mainly your husband/wife/partner 10 Jointly with your husband/wife/partner 11 Someone else 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Previous COVID-19 like illness for [hh1_fname] [hh1_sname] 2 3 [hh1_fname] [hh1_sname]: Have you EVER come into No

4 contact with anyone that was known or presumed to have Yes (a household member) BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 COVID-19? Yes (at work) 6 Close contact includes: Yes (a non-household friend or relation) 7 Physical contact with another personA five minute Yes (in public) conversation with someone less than 2 metres awayBeing Yes (other) 8 less than 2 metres away from someone for 15 minutes or Don't know 9 more, even if you didn't talk to each otherPlease 10 select all that apply. 11 12 13 Did this person have COVID confirmed by a laboratory Yes 14 test? No 15 Don't know 16 17 [hh1_fname] [hh1_sname]: Have you had an illness Yes 18 involving Cough, or Fever, or LossFor of sense peer of smell reviewNo only 19 since the 1st of January 2020? 20 21 [hh1_fname] [hh1_sname]: Which month did the illness start and which symptoms did you have? 22 If you had more than one illness, you may select multiple start months 23 24 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb 25 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2020 2021 2021 26 Cough 27 28 Fever 29 Loss of sense of smell 30 31 32 [hh1_fname] [hh1_sname]: COVID-19 can cause a wide Yes 33 range of symptoms. Have you had an illness that you No 34 think might have been COVID-19, or which was confirmed 35 as COVID-19? 36 http://bmjopen.bmj.com/ 37 Please describe in your own words how did the illness 38 started and what you did when you started to feel ill? 39 ______40 41 Please describe in your own words, what symptoms 42 developed and what did you do? 43 ______44 on September 29, 2021 by guest. Protected copyright. 45 46 Please describe in your own words, how long did your 47 symptoms last and are any symptoms still there? 48 ______49 50 [hh1_fname] [hh1_sname]: Have you ever had a nose or Yes 51 throat swab test for COVID-19? No 52 Not Sure 53 54 What month was the swab taken and what was the result? 55 Please select all the months in which you took each test (if you took multiple) and their results 56 57 58 59 60

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12/03/2021 1:10pm projectredcap.org Confidential Page 47 of 80 BMJ Open Page 21 The test was positive The test was negative The test was unclear I haven't had the 1 Jan 2020 result 2 Feb 2020 3

4 Mar 2020 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Apr 2020 6 7 May 2020 8 Jun 2020 9 Jul 2020 10 11 Aug 2020 12 Sep 2020 13 14 Oct 2020 15 Nov 2020 16 Dec 2020 17 18 Jan 2021 For peer review only 19 Feb 2021 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Thank You 2 3 We want to know what questions you think are important so we can try to answer them with the help of tens of

4 thousands of Virus Watch participants. Each month we will ask our participants to say what questions they would BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 like to see answered. 6 7 [hh1_fname] [hh1_sname]: What questions would you like 8 Virus Watch to answer? 9 ______10 11 As we come out of a very difficult and tragic period we want to know about your three main worries related to 12 COVID-19 and the COVID-19 response. 13 14 [hh1_fname] [hh1_sname]: What are your three main worries about the COVID-19 pandemic? 15 16 1st most worrying aspect: 17 ______18 For peer review only 19 20 2nd most worrying aspect: 21 ______22 23 3rd most worrying aspect: 24 ______25 26 Please click submit to continue 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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12/03/2021 1:10pm projectredcap.org Confidential Page 49 of 80 BMJ Open Page 1 Weekly Survey 1 2 3

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 Welcome to the weekly followup survey 7 surveydate 8 ______9 10 11 In Virus Watch we are interested in the following types of symptoms: 12 General symptoms (e.g. fevers, general muscle aches, headache, joint pain,extreme tiredness, trouble with daily 13 activities around the house)Respiratory Symptoms (e.g. cough, shortness of breath, earache, sore throat, runny 14 nose, blocked nose, sneezing, wheeze, loss or altered senses of smell or taste).Eyes (e.g. eye redness, eye 15 pain,sticky eye, deterioration of eyesight)RashesDigestive symptoms (e.g. diarrhoea or loose stools, vomiting, nausea, abdominal pain)This survey is about symptoms in the week (Monday to Sunday) before you received the 16 email with the survey link. 17 18 For peer review only 19 Download Symptom Diary 20 21 [Attachment: "Virus_Watch_Symptom_Diary.pdf"] 22 23 Have you or anyone in the household had any of these Yes 24 symptoms in the past week? No 25 26 Please continue to report weekly symptoms even if you 27 believe them to be related to a recent vaccine you 28 have had. 29 30 Did any household members receive a COVID-19 test Yes 31 result in the past week? No 32 33 Has anyone in the household been advised to Yes 34 self-isolate in the past week? No 35 36 http://bmjopen.bmj.com/ 37 Please indicate who received a result for a COVID-19 (swab or lateral flow) test in the past week: If you have had 38 multiple tests this week please report any positive test dates OR your last negative test dates (if all were negative) 39 40 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 41 42 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: What was Positive 43 the result of the COVID-19 test? Negative 44 Unclear on September 29, 2021 by guest. Protected copyright. 45 46 47 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: When was 48 the test taken? ______49 50 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: When did 51 you receive the test result? ______52 53 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname] 54 55 56 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: What was Positive 57 the result of the COVID-19 test? Negative 58 Unclear 59 60 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: When was the test taken? ______

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1 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: When did 2 you receive the test result? ______3

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname] 6 7 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: What was Positive 8 the result of the COVID-19 test? Negative 9 Unclear 10 11 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: When was 12 the test taken? ______13 14 15 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: When did you receive the test result? ______16 17 18 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]For peer review only 19 20 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: What was Positive 21 the result of the COVID-19 test? Negative 22 Unclear 23 24 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: When was 25 the test taken? ______26 27 28 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: When did 29 you receive the test result? ______30 31 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname] 32 33 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: What was Positive 34 the result of the COVID-19 test? Negative 35 Unclear 36 http://bmjopen.bmj.com/ 37 38 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: When was 39 the test taken? ______40 41 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: When did 42 you receive the test result? ______43 44 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname] on September 29, 2021 by guest. Protected copyright. 45 46 47 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: What was Positive 48 the result of the COVID-19 test? Negative 49 Unclear 50 51 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: When was 52 the test taken? ______53 54 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: When did 55 you receive the test result? ______56 57 58 Please indicate who was advised to self isolate in the past week: 59 60 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]

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1 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which of The Test and Trace programme advised me to 2 the following led to the request to self-isolate? self-isolate because I have symptoms of COVID-19 3 The Test and Trace programme advised me to 4 self-isolate because I am had a positive test BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 result 6 The Test and Trace programme advised me to self 7 isolate because I was in contact with a COVID-19 8 case 9 The NHS COVID-19 app alerted me that I had been in 10 contact with a COVID-19 case 11 I have returned from a country where quarantine is 12 advised after return. 13 Other reason 14 15 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname] 16 17 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: Which of The Test and Trace programme advised me to 18 the following led to the requestFor to self-isolate? peer reviewself-isolate only because I have symptoms of COVID-19 19 The Test and Trace programme advised me to 20 self-isolate because I am had a positive test 21 result 22 The Test and Trace programme advised me to self 23 isolate because I was in contact with a COVID-19 24 case 25 The NHS COVID-19 app alerted me that I had been in 26 contact with a COVID-19 case 27 I have returned from a country where quarantine is 28 advised after return. 29 Other reason 30 31 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname] 32 33 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: Which of The Test and Trace programme advised me to 34 the following led to the request to self-isolate? self-isolate because I have symptoms of COVID-19 35 The Test and Trace programme advised me to 36 self-isolate because I am had a positive test http://bmjopen.bmj.com/ 37 result 38 The Test and Trace programme advised me to self 39 isolate because I was in contact with a COVID-19 40 case 41 The NHS COVID-19 app alerted me that I had been in 42 contact with a COVID-19 case 43 I have returned from a country where quarantine is 44 advised after return. on September 29, 2021 by guest. Protected copyright. 45 Other reason 46 47 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname] 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: Which of The Test and Trace programme advised me to 2 the following led to the request to self-isolate? self-isolate because I have symptoms of COVID-19 3 The Test and Trace programme advised me to 4 self-isolate because I am had a positive test BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 result 6 The Test and Trace programme advised me to self 7 isolate because I was in contact with a COVID-19 8 case 9 The NHS COVID-19 app alerted me that I had been in 10 contact with a COVID-19 case 11 I have returned from a country where quarantine is 12 advised after return. 13 Other reason 14 15 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname] 16 17 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: Which of The Test and Trace programme advised me to 18 the following led to the requestFor to self-isolate? peer reviewself-isolate only because I have symptoms of COVID-19 19 The Test and Trace programme advised me to 20 self-isolate because I am had a positive test 21 result 22 The Test and Trace programme advised me to self 23 isolate because I was in contact with a COVID-19 24 case 25 The NHS COVID-19 app alerted me that I had been in 26 contact with a COVID-19 case 27 I have returned from a country where quarantine is 28 advised after return. 29 Other reason 30 31 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname] 32 33 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: Which of The Test and Trace programme advised me to 34 the following led to the request to self-isolate? self-isolate because I have symptoms of COVID-19 35 The Test and Trace programme advised me to 36 self-isolate because I am had a positive test http://bmjopen.bmj.com/ 37 result 38 The Test and Trace programme advised me to self 39 isolate because I was in contact with a COVID-19 40 case 41 The NHS COVID-19 app alerted me that I had been in 42 contact with a COVID-19 case 43 I have returned from a country where quarantine is 44 advised after return. on September 29, 2021 by guest. Protected copyright. 45 Other reason 46 47 Please indicate who has had symptoms in the past week: 48 49 50 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Yes, symptoms that have been present for less than 2 months 51 Yes, symptoms that developed after a COVID-19 like 52 illness and have lasted for more than 2 months 53 Yes, symptoms that are part of a long term chronic 54 illness 55 No symptoms 56 57 58 59 60

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1 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: Yes, symptoms that have been present for less than 2 2 months 3 Yes, symptoms that developed after a COVID-19 like 4 illness and have lasted for more than 2 months BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Yes, symptoms that are part of a long term chronic 6 illness 7 No symptoms 8 9 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: Yes, symptoms that have been present for less than 10 2 months 11 Yes, symptoms that developed after a COVID-19 like 12 illness and have lasted for more than 2 months 13 Yes, symptoms that are part of a long term chronic 14 illness 15 No symptoms 16 17 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: Yes, symptoms that have been present for less than 18 For peer review2 monthsonly 19 Yes, symptoms that developed after a COVID-19 like 20 illness and have lasted for more than 2 months 21 Yes, symptoms that are part of a long term chronic 22 illness 23 No symptoms 24 25 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: Yes, symptoms that have been present for less than 26 2 months 27 Yes, symptoms that developed after a COVID-19 like 28 illness and have lasted for more than 2 months 29 Yes, symptoms that are part of a long term chronic 30 illness 31 No symptoms 32 33 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: Yes, symptoms that have been present for less than 34 2 months 35 Yes, symptoms that developed after a COVID-19 like 36 illness and have lasted for more than 2 months http://bmjopen.bmj.com/ 37 Yes, symptoms that are part of a long term chronic 38 illness 39 No symptoms 40 41 Please indicate whether the following members have received a result for a COVID-19 (swab or lateral flow) test in 42 the past week: If you have had multiple tests this week please report any positive test dates OR your last negative 43 test dates (if all were negative) 44 on September 29, 2021 by guest. Protected copyright. 45 46 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: 47 48 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: What was Positive 49 the result of this test? Negative 50 Unclear 51 52 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: When was 53 the test taken? ______54 55 56 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: When did 57 you receive the test result? ______58 59 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: 60

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1 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: What was Positive 2 the result of this test? Negative 3 Unclear 4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: When was 7 the test taken? ______8 9 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: When did 10 you receive the test result? ______11 12 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: 13 14 15 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: What was Positive the result of this test? Negative 16 Unclear 17 18 For peer review only 19 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: When was 20 the test taken? ______21 22 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: When did 23 you receive the test result? ______24 25 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: 26 27 28 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: What was Positive 29 the result of this test? Negative 30 Unclear 31 32 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: When was 33 the test taken? ______34 35 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: When did 36 you receive the test result? ______http://bmjopen.bmj.com/ 37 38 39 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: 40 41 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: What was Positive 42 the result of this test? Negative 43 Unclear 44 on September 29, 2021 by guest. Protected copyright. 45 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: When was 46 the test taken? ______47 48 49 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: When did 50 you receive the test result? ______51 52 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: 53 54 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: What was Positive 55 the result of this test? Negative 56 Unclear 57 58 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: When was 59 the test taken? ______60

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1 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: When did 2 you receive the test result? ______3

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Please indiciate whether the following household members been advised to self-isolate in the past week: 6 7 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 8 9 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which of The Test and Trace programme advised me to 10 the following led to the request to self-isolate? self-isolate because I have symptoms of COVID-19 11 The Test and Trace programme advised me to 12 self-isolate because I am had a positive test 13 result 14 The Test and Trace programme advised me to self 15 isolate because I was in contact with a COVID-19 16 case 17 The NHS COVID-19 app alerted me that I had been in 18 For peer reviewcontact only with a COVID-19 case 19 I have returned from a country where quarantine is 20 advised after return. 21 Other reason 22 23 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname] 24 25 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: Which of The Test and Trace programme advised me to 26 the following led to the request to self-isolate? self-isolate because I have symptoms of COVID-19 27 The Test and Trace programme advised me to 28 self-isolate because I am had a positive test 29 result 30 The Test and Trace programme advised me to self 31 isolate because I was in contact with a COVID-19 32 case 33 The NHS COVID-19 app alerted me that I had been in 34 contact with a COVID-19 case 35 I have returned from a country where quarantine is 36 advised after return. http://bmjopen.bmj.com/ 37 Other reason 38 39 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname] 40 41 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: Which of The Test and Trace programme advised me to 42 the following led to the request to self-isolate? self-isolate because I have symptoms of COVID-19 43 The Test and Trace programme advised me to 44 self-isolate because I am had a positive test on September 29, 2021 by guest. Protected copyright. 45 result 46 The Test and Trace programme advised me to self 47 isolate because I was in contact with a COVID-19 48 case 49 The NHS COVID-19 app alerted me that I had been in 50 contact with a COVID-19 case 51 I have returned from a country where quarantine is 52 advised after return. 53 Other reason 54 55 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname] 56 57 58 59 60

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1 Vaccination 2 3 Has anyone in the household received a COVID-19 Yes

4 vaccine in the past week? No BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Unsure (e.g. as part of a blinded COVID-19 trial) 6 7 Please indicate who received a COVID-19 vaccine: 8 9 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 10 11 12 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Please 1st Dose 13 select which dose(s) of the COVID-19 vaccine you 2nd Dose 14 received? 15 16 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which Pfizer Biontech vaccine 17 type of vaccine did you receive as the 1st dose? Oxford AstraZeneca vaccine 18 For peer reviewOther only vaccine 19 Don't know/Don't remember 20 21 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: What date 22 did you receive the 1st dose? ______23 (dd-mm-yyyy) 24 25 Please provide an estimate if you cannot recall the 26 date 27 28 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which Pfizer Biontech vaccine 29 type of vaccine did you receive as the 2nd dose? Oxford AstraZeneca vaccine 30 Other vaccine 31 Don't know/Don't remember 32 33 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: What date 34 did you receive the 2nd dose? ______35 (dd-mm-yyyy) 36 http://bmjopen.bmj.com/ 37 Please provide an estimate if you cannot recall the 38 date 39 40 41 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname] 42 43 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: Please 1st Dose 44 select which dose(s) of the COVID-19 vaccine you 2nd Dose on September 29, 2021 by guest. Protected copyright. 45 received? 46 47 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: Which Pfizer Biontech vaccine 48 type of vaccine did you receive as the 1st dose? Oxford AstraZeneca vaccine 49 Other vaccine 50 Don't know/Don't remember 51 52 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: What date 53 did you receive the 1st dose? (dd-mm-yyyy) ______54 55 Please provide an estimate if you cannot recall the 56 date 57 58 59 60

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1 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: Which Pfizer Biontech vaccine 2 type of vaccine did you receive as the 2nd dose? Oxford AstraZeneca vaccine 3 Other vaccine 4 Don't know/Don't remember BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 7 [go_arm_1][hh2_fname] [go_arm_1][hh2_sname]: What date did you receive the 2nd dose? (dd-mm-yyyy) ______8 9 Please provide an estimate if you cannot recall the 10 date 11 12 13 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname] 14 15 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: Please 1st Dose 16 select which dose(s) of the COVID-19 vaccine you 2nd Dose 17 received? 18 For peer review only 19 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: Which Pfizer Biontech vaccine 20 type of vaccine did you receive as the 1st dose? Oxford AstraZeneca vaccine 21 Other vaccine 22 Don't know/Don't remember 23 24 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: What date 25 did you receive the 1st dose? (dd-mm-yyyy) ______26 27 Please provide an estimate if you cannot recall the 28 date 29 30 31 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: Which Pfizer Biontech vaccine 32 type of vaccine did you receive as the 2nd dose? Oxford AstraZeneca vaccine Other vaccine 33 Don't know/Don't remember 34 35 36 [go_arm_1][hh3_fname] [go_arm_1][hh3_sname]: What date http://bmjopen.bmj.com/ 37 did you receive the 2nd dose? (dd-mm-yyyy) ______38 39 Please provide an estimate if you cannot recall the 40 date 41 42 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname] 43 44 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: Please 1st Dose on September 29, 2021 by guest. Protected copyright. 45 select which dose(s) of the COVID-19 vaccine you 2nd Dose 46 received? 47 48 49 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: Which Pfizer Biontech vaccine 50 type of vaccine did you receive as the 1st dose? Oxford AstraZeneca vaccine Other vaccine 51 Don't know/Don't remember 52 53 54 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: What date 55 did you receive the 1st dose? (dd-mm-yyyy) ______56 57 Please provide an estimate if you cannot recall the 58 date 59 60

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1 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: Which Pfizer Biontech vaccine 2 type of vaccine did you receive as the 2nd dose? Oxford AstraZeneca vaccine 3 Other vaccine 4 Don't know/Don't remember BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 7 [go_arm_1][hh4_fname] [go_arm_1][hh4_sname]: What date did you receive the 2nd dose? (dd-mm-yyyy) ______8 9 Please provide an estimate if you cannot recall the 10 date 11 12 13 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname] 14 15 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: Please 1st Dose 16 select which dose(s) of the COVID-19 vaccine you 2nd Dose 17 received? 18 For peer review only 19 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: Which Pfizer Biontech vaccine 20 type of vaccine did you receive as the 1st dose? Oxford AstraZeneca vaccine 21 Other vaccine 22 Don't know/Don't remember 23 24 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: What date 25 did you receive the 1st dose? (dd-mm-yyyy) ______26 27 Please provide an estimate if you cannot recall the 28 date 29 30 31 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: Which Pfizer Biontech vaccine 32 type of vaccine did you receive as the 2nd dose? Oxford AstraZeneca vaccine Other vaccine 33 Don't know/Don't remember 34 35 36 [go_arm_1][hh5_fname] [go_arm_1][hh5_sname]: What date http://bmjopen.bmj.com/ 37 did you receive the 2nd dose? (dd-mm-yyyy) ______38 39 Please provide an estimate if you cannot recall the 40 date 41 42 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname] 43 44 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: Please 1st Dose on September 29, 2021 by guest. Protected copyright. 45 select which dose(s) of the COVID-19 vaccine you 2nd Dose 46 received? 47 48 49 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: Which Pfizer Biontech vaccine 50 type of vaccine did you receive as the 1st dose? Oxford AstraZeneca vaccine Other vaccine 51 Don't know/Don't remember 52 53 54 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: What date 55 did you receive the 1st dose? (dd-mm-yyyy) ______56 57 Please provide an estimate if you cannot recall the 58 date 59 60

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1 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: Which Pfizer Biontech vaccine 2 type of vaccine did you receive as the 2nd dose? Oxford AstraZeneca vaccine 3 Other vaccine 4 Don't know/Don't remember BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 7 [go_arm_1][hh6_fname] [go_arm_1][hh6_sname]: What date did you receive the 2nd dose? (dd-mm-yyyy) ______8 9 Please provide an estimate if you cannot recall the 10 date 11 12 13 Thank you for letting us know that someone in your household has been ill. We hope they feel better soon. Please 14 always follow NHS and Public Health advice when someone is ill. We will always have a link to the latest COVID-19 15 advice on the Virus Watch Website. 16 If anyone has new symptoms to report, the following survey will ask about any illness and related health care as well 17 as asking about isolation, time off work, measures to help stop infections spreading and activities that household 18 members have done in the lastFor week. peer review only 19 20 The survey usually takes about 10 minutes to complete for each member of the household who has been ill. 21 22 23 Thank you for completing the survey - we will be in touch again next week. 24 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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12/03/2021 1:10pm projectredcap.org Confidential Page 61 of 80 BMJ Open Page 1 Wkhh1 1 2 3

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 Symptoms - [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 7 The following sections are about the symptoms, use of treatments and access of medical services in the past week 8 (the Monday-Sunday before you received the email with this survey link). 9 10 11 [go_arm_1][hh1_fname]: What parts of the body did your General symptoms (fevers, general muscle aches, 12 symptoms affect? headache, joint pain,extreme tiredness, trouble 13 Select all that apply with daily activities around the house) 14 Respiratory Symptoms (e.g. cough, shortness of 15 breath, earache, sore throat, runny nose, blocked nose, sneezing, wheeze, loss or altered senses of 16 smell or taste) 17 Eyes (e.g. eye redness, eye pain, sticky eye, 18 For peer reviewdeterioration only of eyesight) 19 Rash 20 Digestive symptoms (e.g. diarrhoea or loose 21 stools, vomiting, nausea, abdominal pain) 22 23 24 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which Monday days did you have symptoms? Tuesday 25 Please check all days that you had any of the above Wednesday 26 symptoms. Thursday 27 Friday 28 Saturday 29 Sunday 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 General symptoms - [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 2 3 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which of Fever

4 these general symptoms did you have? Feeling Feverish BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Select all that apply Chills and shakes 6 Night Sweats 7 Muscle Aches Bone or Joint Aches 8 Loss of Appetite 9 Headache 10 Lack of concentration 11 Lighheaded or dizzy 12 Not sleeping 13 Fatigue / Feeling unusually tired 14 Difficulty with daily activities around the house 15 Needed extra time in bed 16 Could not get out of bed 17 Confusion, disorientation, or hallucinations 18 For peer review(altered only mental state) 19 None of these symptoms 20 21 Please identify how severe your symptoms were 22 23 24 Fever 25 Less than 37.8 C 37.8-38.9 C 39-39.9 C 40 C (104 F) or Did not take 26 (100.0 F) (100-102 F) (102-103.9 F) more temperature 27 Don't remember 28 29 Monday 30 Tuesday 31 32 Wednesday 33 Thursday 34 35 Friday 36

Saturday http://bmjopen.bmj.com/ 37 Sunday 38 39 40 Feeling Feverish 41 42 None Mild Moderate Severe 43 Monday 44 on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 Wednesday 47 48 Thursday 49 Friday 50 Saturday 51 52 Sunday 53 54 55 Chills and Shakes 56 57 58 59 60

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12/03/2021 1:10pm projectredcap.org Confidential Page 63 of 80 BMJ Open Page 3 None Mild Moderate Severe 1 Monday 2 Tuesday 3

4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Night Sweats 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 Muscle Ache 28 None Mild Moderate Severe 29 30 Monday 31 Tuesday 32 Wednesday 33 34 Thursday 35 Friday 36 http://bmjopen.bmj.com/ 37 Saturday 38 Sunday 39 40 41 Bone or Joint ache 42 43 None Mild Moderate Severe 44

Monday on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 47 Wednesday 48 Thursday 49 50 Friday 51 Saturday 52 53 Sunday 54 55 Loss of Appetite 56 57 58 59 60

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12/03/2021 1:10pm projectredcap.org Confidential BMJ Open Page 64 of 80 Page 4 None Mild Moderate Severe 1 Monday 2 Tuesday 3

4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Headache 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 Confusion, disorientation, or hallucinations (altered mental state) 28 None Mild Moderate Severe 29 30 Monday 31 Tuesday 32 Wednesday 33 34 Thursday 35 Friday 36 http://bmjopen.bmj.com/ 37 Saturday 38 Sunday 39 40 41 Lack of Concentration 42 43 None Mild Moderate Severe 44

Monday on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 47 Wednesday 48 Thursday 49 50 Friday 51 Saturday 52 53 Sunday 54 55 Lightheaded or Dizzy 56 57 58 59 60

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12/03/2021 1:10pm projectredcap.org Confidential Page 65 of 80 BMJ Open Page 5 None Mild Moderate Severe 1 Monday 2 Tuesday 3

4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Not Sleeping 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 Fatigue/Feeling Unusually Tired 28 None Mild Moderate Severe 29 30 Monday 31 Tuesday 32 Wednesday 33 34 Thursday 35 Friday 36 http://bmjopen.bmj.com/ 37 Saturday 38 Sunday 39 40 41 Difficulties with Daily Activities 42 43 None Mild Moderate Severe 44

Monday on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 47 Wednesday 48 Thursday 49 50 Friday 51 Saturday 52 53 Sunday 54 55 Needed extra time in bed 56 57 58 59 60

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4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Could not get out of bed 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Respiratory Symptoms - [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 2 3 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which Runny Nose

4 Respiratory symptoms did you have? Blocked Nose BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Select all that apply Sinus pain / congestion 6 Dry cough 7 Coughing up Green Phlegm Coughing up White Phlegm 8 Loss or change to sense of smell 9 Loss or change to sense of taste 10 Sneezing 11 Sore Throat 12 Swollen tonsils 13 Swollen glands (enlarged lymph nodes) 14 Ear pain or change in hearing 15 Fluid leaking from ear 16 Shortness of breath difficulty breathing 17 Wheezing 18 For peer reviewChest only pain (not changed by breathing or moving) 19 Chest pain when breathing in 20 None of these symptoms 21 22 Please identify how severe your symptoms were 23 24 Runny Nose 25 26 None Mild Moderate Severe 27 28 Monday 29 Tuesday 30 Wednesday 31 32 Thursday 33 Friday 34 35 Saturday 36

Sunday http://bmjopen.bmj.com/ 37 38 39 Blocked Nose 40 41 None Mild Moderate Severe 42 Monday 43 Tuesday 44 on September 29, 2021 by guest. Protected copyright. 45 Wednesday 46 Thursday 47 48 Friday 49 Saturday 50 Sunday 51 52 53 Sinus Pain/Congestion 54 55 None Mild Moderate Severe 56 Monday 57 58 59 60

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1 Tuesday 2 Wednesday 3

4 Thursday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Friday 6 7 Saturday 8 Sunday 9 10 11 Dry cough 12 13 None Mild Moderate Severe 14 Monday 15 Tuesday 16 17 Wednesday 18 Thursday For peer review only 19 20 Friday 21 Saturday 22 Sunday 23 24 25 Coughing up Green Phlegm 26 27 None Mild Moderate Severe 28 Monday 29 30 Tuesday 31 Wednesday 32 Thursday 33 34 Friday 35 Saturday 36 http://bmjopen.bmj.com/ 37 Sunday 38 39 40 Coughing up White Phlegm 41 None Mild Moderate Severe 42 43 Monday 44

Tuesday on September 29, 2021 by guest. Protected copyright. 45 Wednesday 46 47 Thursday 48 Friday 49 50 Saturday 51 Sunday 52 53 54 Loss or change to sense of smell 55 56 57 58 59 60

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

12/03/2021 1:10pm projectredcap.org Confidential Page 69 of 80 BMJ Open Page 9 None Mild Moderate Severe 1 Monday 2 Tuesday 3

4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Loss or change to sense of taste 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 Sneezing 28 None Mild Moderate Severe 29 30 Monday 31 Tuesday 32 Wednesday 33 34 Thursday 35 Friday 36 http://bmjopen.bmj.com/ 37 Saturday 38 Sunday 39 40 41 Sore Throat 42 43 None Mild Moderate Severe 44

Monday on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 47 Wednesday 48 Thursday 49 50 Friday 51 Saturday 52 53 Sunday 54 55 Swollen Tonsils 56 57 58 59 60

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12/03/2021 1:10pm projectredcap.org Confidential BMJ Open Page 70 of 80 Page 10 None Mild Moderate Severe 1 Monday 2 Tuesday 3

4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Swollen Glands (enlarged lymph nodes) 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 Ear pain or change in hearing 28 None Mild Moderate Severe 29 30 Monday 31 Tuesday 32 Wednesday 33 34 Thursday 35 Friday 36 http://bmjopen.bmj.com/ 37 Saturday 38 Sunday 39 40 41 Fluid leaking from ear 42 43 None Mild Moderate Severe 44

Monday on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 47 Wednesday 48 Thursday 49 50 Friday 51 Saturday 52 53 Sunday 54 55 Shortness of Breath/difficulty breathing 56 57 58 59 60

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

12/03/2021 1:10pm projectredcap.org Confidential Page 71 of 80 BMJ Open Page 11 None Mild Moderate Severe 1 Monday 2 Tuesday 3

4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Wheezing 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 Chest pain (not changed by breathing or moving) 28 None Mild Moderate Severe 29 30 Monday 31 Tuesday 32 Wednesday 33 34 Thursday 35 Friday 36 http://bmjopen.bmj.com/ 37 Saturday 38 Sunday 39 40 41 Chest pain when breathing in 42 43 None Mild Moderate Severe 44

Monday on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 47 Wednesday 48 Thursday 49 50 Friday 51 Saturday 52 53 Sunday 54 55 56 57 58 59 60

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1 Other Symptoms - [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 2 3 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which eye Eye redness

4 related symptoms did you have this week? Sticky Eye BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Select all that apply Eye pain 6 Deterioration of eyesight 7 None of these symptoms 8 9 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Where did Rash (all over) 10 the rash affect you? Rash (local) 11 None of these symptoms 12 13 Where on the body did the rash affect you? 14 ______15 16 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Which Diarrhoea (even mild) 17 gastrointestinal symptoms did you have? Vomiting (being sick) 18 Select all that apply For peer reviewNausea only (feeling sick) 19 Abdominal pain (not including menstrual pain) 20 None of these symptoms 21 22 23 Please identify how severe your symptoms were 24 25 Red Eye(s) 26 27 None Mild Moderate Severe 28 Monday 29 Tuesday 30 31 Wednesday 32 Thursday 33 34 Friday 35 Saturday 36 http://bmjopen.bmj.com/ 37 Sunday 38 39 Sticky Eye(s) 40 41 None Mild Moderate Severe 42 Monday 43 44 Tuesday on September 29, 2021 by guest. Protected copyright. 45 Wednesday 46 47 Thursday 48 Friday 49 50 Saturday 51 Sunday 52 53 54 Eye Pain 55 56 57 58 59 60

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12/03/2021 1:10pm projectredcap.org Confidential Page 73 of 80 BMJ Open Page 13 None Mild Moderate Severe 1 Monday 2 Tuesday 3

4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Deterioration of eyesight 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 Rash - All Over 28 None Mild Moderate Severe 29 30 Monday 31 Tuesday 32 Wednesday 33 34 Thursday 35 Friday 36 http://bmjopen.bmj.com/ 37 Saturday 38 Sunday 39 40 41 Rash - Local 42 43 None Mild Moderate Severe 44

Monday on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 47 Wednesday 48 Thursday 49 50 Friday 51 Saturday 52 53 Sunday 54 55 Diarrhoea (even mild) 56 57 58 59 60

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4 Wednesday BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Thursday 6 7 Friday 8 Saturday 9 Sunday 10 11 12 Vomiting (being sick) 13 14 None Mild Moderate Severe 15 Monday 16 17 Tuesday 18 Wednesday For peer review only 19 20 Thursday 21 Friday 22 Saturday 23 24 Sunday 25 26 27 Nausea (feeling sick) 28 None Mild Moderate Severe 29 30 Monday 31 Tuesday 32 Wednesday 33 34 Thursday 35 Friday 36 http://bmjopen.bmj.com/ 37 Saturday 38 Sunday 39 40 41 Abdominal pain (not including menstrual pain) 42 43 None Mild Moderate Severe 44

Monday on September 29, 2021 by guest. Protected copyright. 45 Tuesday 46 47 Wednesday 48 Thursday 49 50 Friday 51 Saturday 52 53 Sunday 54 55 56 57 58 59 60

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1 COVID-19 testing for [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 2 3 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Have you Yes

4 sought COVID-19 testing for this illness via the NHS, No BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 government or your employer? 6 7 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: You said Yes 8 you tried to get tested for COVID-19 via the NHS, No 9 government or your employer for this illness. Did you 10 get tested? 11 12 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Why did I was advised the test was not needed 13 you not get an NHS test for COVID-19? I am waiting for an NHS test kit to arrive by post 14 I could not get to a testing centre 15 I felt better so decided not to get tested 16 Other - please specify 17 18 Other (please specify): For peer review only 19 ______20 21 22 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: How long Same day 23 was the gap between your symptoms starting and you Next day 24 having an NHS COVID-19 test? 2 days later 3 to 4 days later 25 5 to 7 days later 26 More than a week 27 28 29 What was the result of that test? Positive for COVID-19 30 Negative for COVID-19 31 The result was unclear 32 Still awaiting result 33 34 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: How long Same day 35 was the gap between your symptoms starting and you Next day 36 getting the NHS test results? 2 days later http://bmjopen.bmj.com/ 37 3 to 4 days later 38 5 to 7 days later 39 More than a week 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Tracing - [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 2 3 If you had an illness that may be COVID-19 you should follow national advice on reporting this illness and seeking

4 care. We will always have a link to the latest advice on the Virus Watch website. BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Have you I did not report my illness to any other 7 reported your illness to any organisation other than organisation 8 Virus Watch? Yes to the NHS Contact tracing app 9 Select all that apply Yes to Google/Android contact tracing app 10 Yes to the NHS Test and Trace service 11 Yes to my employer 12 Yes to my GP 13 Yes to the NHS 111 online coronavirus service 14 Yes to the general NHS 111 service 15 Other (please specify) 16 17 Other (please specify) 18 For peer review______only 19 20 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Why did I did not think it was COVID-19 21 you not report your illness? I didn't feel ill enough to need help 22 I didn't know where to report it 23 I didn't know I was supposed to report it 24 I didn't want to self isolate 25 I didn't want my contacts to have to self isolate 26 I didn't want others to know that I might have 27 COVID-19 28 29 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: From the Non-Household Direct Contacts - these are people 30 time two days before your illness started to now, have you had direct physical contact with or with whom 31 you had direct or close contact with anyone OTHER you exchanged at least a few words within a 2 32 THAN HOUSEHOLD MEMBERS? metre distance (e.g. a handshake, embracing, 33 kissing, contact sports). 34 Non-Household Close contacts - these are people 35 who were within 2 metres of you for 15 minutes or 36 more but who you did not speak to or touch. http://bmjopen.bmj.com/ 37 I did not have direct or close contact with 38 anybody other than household members 39 40 How many people did you have DIRECT CONTACT with other 41 than household members? ______42 Please enter digits only, e.g. '5' and not 'five' 43 44 How many people did you have CLOSE CONTACT with on September 29, 2021 by guest. Protected copyright. 45 other than household members? ______46 Please enter digits only, e.g. '5' and not 'five' 47 48 49 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Has No 50 anyone contacted you to ask about who you have been in Yes - my GP contact with prior to or during your illness(contact Yes - the NHS Test and Trace System 51 tracing)? Yes - telephone advisory service 52 Please select all that apply Yes - through an online form 53 Yes - through an app 54 Yes - through my employer 55 Yes - through my place of education 56 Yes - the local public team 57 Other - please specify 58 59 Other please specify: 60 ______

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1 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Was Yes - and I know how many were asked to self 2 anyone other than a household member asked to isolate 3 self-isolate because of contact with you? Yes - but I don't know how many were asked to self 4 isolate BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Nobody was asked to self isolate 6 I don't know if anyone was asked to self isolate 7 8 How many people other than household contacts were 9 asked to self-isolate because of contact with you? ______10 Please enter digits only, e.g. '5' and not 'five' 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Health Advice / Consultation - [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 2 3 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: You should follow official national advice about what to do if you

4 have symptoms of COVID-19. We will always include a link to the latest advice on the Virus Watch website. BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 6 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Did the Yes 7 illness lead you (or someone else on your behalf) to No 8 seek advice about your symptoms this week? 9 This includes advice from: NHS 111 PharmaciesNurses or 10 doctorsThe internetFriends and family 11 12 Where was the advice or information sought from? NHS 111 COVID-19 website 13 NHS 111 COVID-19 phone line 14 COVID-19 testing centre 15 Internet (e.g. WebMD , NHS choices) 16 Pharmacist 17 GP (by phone) 18 For peer reviewGP only(visit to practice) 19 GP (online (including video)) 20 Walk-in centre 21 A&E 22 Hospital 23 Friends or family 24 Other (please specify) 25 26 Other (Please Specify): 27 ______28 29 On which days was the medical advice or information sought from these sources Please check all that that apply on 30 each day 31 32 Monday Tuesday Wednesday Thursday Friday Saturday Sunday 33 Internet (e.g. WebMD , NHS 34 choices) 35 36 NHS 111 COVID-19 phone line http://bmjopen.bmj.com/ 37 NHS 111 COVID-19 website 38 39 Pharmacist 40 GP (by phone) 41 42 GP (visit to practice) 43 GP (online (including video)) 44 Walk-in centre on September 29, 2021 by guest. Protected copyright. 45 46 COVID-19 testing centre 47 A&E 48 49 Hospital 50 51 52 53 54 55 56 57 58 59 60

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1 Medication - [go_arm_1][hh1_fname] [go_arm_1][hh1_sname] 2 3 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Did your Yes

4 symptoms lead to taking any medicines during the No BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 survey week? 6 This includes prescribed medicines, medicine brought 7 at the chemist or shops, or vitamin supplements 8 9 On which days did you take the medicines: 10 Please select all that apply 11 12 Mon Tues Wed Thurs Fri Sat Sun 13 Paracetamol 14 Ibuprofen, nurofen, diclofenac, 15 naproxen or other NSAID 16 17 Aspirin 18 Antibiotics For peer review only 19 20 Cold or flu remedies - over the 21 counter 22 Vitamin Supplements 23 24 Other (please describe) 25 26 27 Please specify: 28 ______29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Isolation and Infection Control - [go_arm_1][hh1_fname] 2 3 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: During the past week, on which days did you:

4 BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 Mon Tues Wed Thurs Fri Sat Sun None 6 Leave the house/flat or garden 7 Wear a facemask or face 8 covering outside the home 9 10 Sleep in a room with no one else 11 in it? 12 13 Wear a face mask or face covering at home? 14 15 Have a meal with other 16 members of your household? 17 18 Watch television with other For peer review only 19 members of your household? 20 21 22 23 24 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: During I did not think my illness was COVID-19, so I did 25 your illness, what best describes your approach to not take any special precautions 26 preventing spread of infection in the household? I thought it would spread whatever I did so did 27 not take special precautions 28 I was worried about the illness spreading to 29 others in the household so did what I could to 30 stop this 31 None of the above 32 33 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Since your illness started, on which days did OTHER MEMBERS OF 34 YOUR HOUSEHOLD: 35 36

Mon Tues Wed Thur Fri Sat Sun None http://bmjopen.bmj.com/ 37 Wear a face mask or face 38 covering when in the same room 39 as you 40 41 Leave the house/flat or garden 42 at all 43 44 Go to work on September 29, 2021 by guest. Protected copyright. 45 Wear a facemask or face 46 covering outside the home 47 48 49 50 51 52 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: Why did They did not think my symptoms were related to 53 other household members leave the house? COVID-19 Please select all that apply They did not think there was any need for people 54 without symptoms to stay at home 55 They needed to go out to earn money 56 They needed to go out to an important meeting 57 Other reason 58 59 60

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1 During your illness, how frequently have you washed Not at all 2 your hands thoroughly and regularly with soap and 1 or 2 times a day 3 water 3 or 4 times a day 4 5 or 6 times a day BMJ Open: first published as 10.1136/bmjopen-2020-048042 on 23 June 2021. Downloaded from 5 7 or 8 times a day 6 9 or 10 times a day 7 More than 10 times a day 8 9 During your illness, on average, how frequently have Several times a day 10 you (or someone else) disinfected surfaces you might Daily 11 touch? Less than daily 12 Such as door knobs or hard surfaces Never 13 14 15 [go_arm_1][hh1_fname] [go_arm_1][hh1_sname]: During your illness, how frequently have you: 16 Not applicable Almost always Most of the Sometimes Rarely Never 17 time 18 For peer review only 19 Washed your hands after 20 blowing your nose, sneezing or 21 coughing 22 23 Used tissues when sneezing or 24 coughing 25 Put tissues in the bin 26 immediately after use 27 28 29 30 31 32 33 34 35 36 http://bmjopen.bmj.com/ 37 38 39 40 41 42 43 44 on September 29, 2021 by guest. Protected copyright. 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60

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1 Thank You 2 3 Please click submit to continue

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