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ISARIC (International Severe Acute Respiratory and Emerging Infections Consortium) medRxiv preprint doi: https://doi.org/10.1101/2020.07.17.20155218; this version posted August 26, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license . ISARIC Clinical Data Report issued: 14 July 2021 International Severe Acute Respiratory and emerging Infections Consortium ISARIC Clinical Characterisation Group*^ *group members, participating institutions and funders are listed at end of report and at https://isaric.org/research/covid-19-clinical- research-resources/covid-19-data-management-hosting/covid-19-clinical-data-contributors-list/ ^Correspondence to: [email protected] 1 1 ISARIC, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK Abstract ISARIC (International Severe Acute Respiratory and emerging Infections Consortium) partnerships and outbreak preparedness initiatives enabled the rapid launch of standardised clinical data collection on COVID-19 in Jan 2020. Extensive global uptake of this resource has resulted in a large, standardised collection of comprehensive clinical data from hundreds of sites across dozens of countries. Data are analysed regularly and reported publicly to inform patient care and public health response. This report, our 15th report, is a part of a series and includes the results of data analysis for data captured before 26 May 2021. The report marks a significant milestone – the submission of clinical data from over half a million individuals hospitalised with COVID-19. We thank all of the data contributors for their ongoing support. Data have been entered for 516,689 individuals from 788 partner institutions and networks, covering 1651 sites across 63 countries. This is an increase of 176,377 case entries and data from an additional 9 countries since our most recent report dated 08 April 2021. The comprehensive analyses detailed in this report includes hospitalised individuals of all ages: 1. for whom data collection occurred between 30 January 2020 and up to and including 25 May 2021; AND 2. who have laboratory-confirmed SARS-COV-2 infection or clinically diagnosed COVID-19. For the 442,643 cases who meet eligibility criteria for this report, selected findings include: o median age of 60 years, with an approximately equal (50/50) male:female sex distribution o one third of the cohort are at least 70 years of age, whereas 3% are 0-19 years of age o the most common symptom combination in this hospitalised cohort is shortness of breath, cough, and history of fever, which has remained constant over time o the five most common symptoms at admission were shortness of breath, cough, history of fever, fatigue/malaise, and altered consciousness/confusion, which is unchanged from the previous reports o age-associated differences in symptoms are evident, including the frequency of altered consciousness increasing with age, and fever, respiratory and constitutional symptoms being present mostly in those 40 years and above o 16% of patients with relevant data available were admitted at some point during their illness into an intensive care unit (ICU), which is slightly lower than previously reported (19%) o antibiotic use remains very high (61%), although it is lower than previously reported (80%), in those for whom relevant data are available (288,125); in ICU/HDU patients with data available (36,073), 92% received antibiotics o use of corticosteroids was reported for 25% of patients of all types for whom data were available (288,125); in ICU/HDU patients with data available (36,021), 62% received corticosteroids o outcomes are known for 411,368 patients and the overall estimated case fatality ratio (CFR) is 25% (95%CI 24.8-25), rising to 38% (95%CI 37.5-38.3) for patients who were admitted to ICU/HDU, demonstrating worse outcomes in those with the most severe disease To access previous versions of ISARIC COVID-19 Clinical Data Report please use the link below: https://isaric.org/research/covid-19-clinical-research-resources/evidence-reports/ NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2020.07.17.20155218; this version posted August 26, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license . ISARIC (International Severe Acute Respiratory and Emerging Infections Consortium) A global federation of clinical research networks, providing a proficient, coordinated, and agile research response to outbreak-prone infectious diseases Background This report describes the clinical presentation, treatment and outcome of a cohort of over half a million patients with COVID-19 hospitalised between January 2020 and June 2021 in 61 countries throughout the world. This has been possible thanks to 788 institutions and their clinical teams contributing to ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium), a grassroots collaboration https://isaric.org/. After one-and-a-half years and over 4 million deaths, COVID-19 is clearly showing us how pandemics disrupt populations by stretching healthcare systems, and shaking economies. Although clinicians and well-equipped surveillance systems can adapt to health emergencies by implementing new treatments and information systems, clinical research lacks this agility. The advantages of an international standardised case record form. Novel diseases are, by defini- tion, new; the scientific method is not. By developing consensus on a road map for clinical research methods before a pandemic, we are able to minimise further time defining study types, data collection tools, andpo- tential outputs for evidence summarisation once the pathogen emerges. Using slightly adjusted standardised methods for novel diseases, evidence can be generated quickly. While small observational studies are easy to conduct, they often record different data or may record vari- ables in different ways. This may not allow data to be collated or findings to be compared across studies,or combined to produce a more powerful and accurate representation. In contrast, large international observa- tional studies with a standardised form allow for international data comparisons, improved analytic control of confounders, and therefore enable the acquisition of high levels of evidence. How we got here with ISARIC. In 2013, ISARIC and the World Health Organisation (WHO) imple- mented the standardised Clinical Characterisation Protocol to evolve clinical data into research evidence during health emergencies. In January 2020, we launched our case report form when only 846 COVID-19 cases had been reported globally. Today, our partners have collected standardised, in-hospital clinical data from over half a million patients, in more than 1600 sites, across 60 countries. More than half of these patients live in low- and middle-income countries. This partner-fueled growing initiative is to our knowledge the largest COVID-19 in-hospital international database in the world. 1 medRxiv preprint doi: https://doi.org/10.1101/2020.07.17.20155218; this version posted August 26, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license . In this report, we present the current state of our database, which all our collaborators can access by submitting a statistical analysis plan to our clinical team. We encourage our collaborators to test their research hypothesis within the framework of ISARIC’s collaborative Partner Analysis scheme [2]. The majority of this database is additionally available to external researchers via application to our Data Access Committee at https://www.iddo.org/covid19/data-sharing/accessing-data. To contribute, please contact [email protected]. Methods The results in this report are produced using data from the ISARIC COVID-19 database of international, prospective observational data on clinical features of patients admitted to hospital with COVID-19. Data collection was structured on the ISARIC/WHO Clinical Characterisation Protocol for Severe Emerging Infections, a standardized protocol for investigation of severe acute infections by pathogens of public health interest [3] and the ISARIC case report forms [4] designed for standardized data collection from the start of an outbreak and rapid dissemination of clinical information [5-9]. Data are collected on Research electronic Data Capture (REDCap, version 8.11.11, Vanderbilt University, Nashville, Tenn.), hosted by the University of Oxford. Additional data, collected using a wide variety of data systems, are submitted by international investigators who are not using the University of Oxford REDCap instance. Data are curated by the Infectious Diseases Data Observatory [10] to the CDISC Study Data Tabulation Model for harmonised analysis [11] The first patient was enrolled on 30 January 2020. SDTM formatted data are processed in R 4.1.0 (R Core Team 2013). Initial data cleaning includes custom scripts designed to identify results of laboratory SARS-CoV-2 testing, and
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