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The Philippine COVID-19 Outcomes: a Retrospective Study of Neurological Manifestations and Associated Symptoms (The Philippine CORONA Study): a Protocol Study

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The Philippine COVID-19 Outcomes: a Retrospective Study of Neurological Manifestations and Associated Symptoms (The Philippine CORONA Study): a Protocol Study Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2020-040944 on 30 November 2020. Downloaded from The Philippine COVID-19 Outcomes: a Retrospective study Of Neurological manifestations and Associated symptoms (The Philippine CORONA study): a protocol study Adrian I Espiritu ,1,2 Marie Charmaine C Sy ,1 Veeda Michelle M Anlacan ,1 Roland Dominic G Jamora 1 To cite: Espiritu AI, Sy MCC, ABSTRACT Strengths and limitations of this study Anlacan VMM, et al. The Introduction The SARS- CoV-2, virus that caused the Philippine COVID-19 Outcomes: COVID-19 global pandemic, possesses a neuroinvasive a etrospective study f ► The Philippine COVID-19 Outcomes: a Retrospective R O potential. Patients with COVID-19 infection present with Neurological manifestations study Of Neurological manifestations and Associated neurological signs and symptoms aside from the usual and Associated symptoms (The symptoms Study is a nationwide, multicentre, retro- Philippine CORONA study): respiratory affectation. Moreover, COVID-19 is associated spective, cohort study with 37 Philippine sites. with several neurological diseases and complications, a protocol study. BMJ Open ► Full spectrum of neurological manifestations of 2020;10:e040944. doi:10.1136/ which may eventually affect clinical outcomes. COVID-19 will be collected. bmjopen-2020-040944 Objectives The Philippine COVID-19 Outcomes: a ► Retrospective gathering of data offers virtually no Retrospective study Of Neurological manifestations and ► Prepublication history for risk of COVID-19 infection to data collectors. this paper is available online. Associated symptoms (The Philippine CORONA) study ► Data from COVID-19 patients who did not go to the To view these files, please visit investigators will conduct a nationwide, multicentre hospital are unobtainable. the journal online (http:// dx. doi. study involving 37 institutions that aims to determine the ► Recoding bias is inherent due to the retrospective org/ 10. 1136/ bmjopen- 2020- neurological manifestations and factors associated with nature of the study. 040944). clinical outcomes in COVID-19 infection. Methodology and analysis This is a retrospective cohort AIE and MCCS are joint first http://bmjopen.bmj.com/ authors. study (comparative between patients with and without the institutional review board of the different study sites. VMMA and RDGJ are joint senior neurological manifestations) via medical chart review authors. involving adult patients with COVID-19 infection. Sample The dissemination of results will be conducted through size was determined at 1342 patients. Demographic, scientific/medical conferences and through journal Received 27 May 2020 clinical and neurological profiles will be obtained and publication. The lay versions of the results may be Revised 12 September 2020 summarised using descriptive statistics. Student’s t-test provided on request. Accepted 27 October 2020 for two independent samples and χ2 test will be used to Trial registration number NCT04386083. determine differences between distributions. HRs and 95% CI will be used as an outcome measure. Kaplan- on September 29, 2021 by guest. Protected copyright. Meier curves will be constructed to plot the time to onset INTRODUCTION of mortality (survival), respiratory failure, intensive care The COVID-19 has been identified as the unit (ICU) admission, duration of ventilator dependence, cause of an outbreak of respiratory illness in length of ICU stay and length of hospital stay. The Wuhan, Hubei Province, China, in December log- rank test will be employed to compare the Kaplan- 2019.1 The COVID-19 pandemic has reached Meier curves. Stratified analysis will be performed to the Philippines with most of its cases found identify confounders and effects modifiers. To compute in the National Capital Region (NCR).2 The © Author(s) (or their for adjusted HR with 95% CI, crude HR of outcomes major clinical features of COVID-19 include will be adjusted according to the prespecified possible employer(s)) 2020. Re- use fever, cough, shortness of breath, myalgia, permitted under CC BY-NC. No confounders. Cox proportional regression models will 3 commercial re- use. See rights be used to determine significant factors of outcomes. headache and diarrhoea. The outcomes of and permissions. Published by Testing for goodness of fit will also be done using Hosmer- this disease lead to prolonged hospital stay, BMJ. Lemeshow test. Subgroup analysis will be performed for intensive care unit (ICU) admission, depen- For numbered affiliations see proven prespecified effect modifiers. The effects of missing dence on invasive mechanical ventilation, end of article. 4 data and outliers will also be evaluated in this study. respiratory failure and mortality. The specific Correspondence to Ethics and dissemination This protocol was approved pathogen that causes this clinical syndrome Dr Adrian I Espiritu; by the Single Joint Research Ethics Board of the has been named SARS- CoV-2, which is aiespiritu@ up. edu. ph Philippine Department of Health (SJREB-2020–24) and phylogenetically similar to SARS-CoV .4 Like Espiritu AI, et al. BMJ Open 2020;10:e040944. doi:10.1136/bmjopen-2020-040944 1 Open access BMJ Open: first published as 10.1136/bmjopen-2020-040944 on 30 November 2020. Downloaded from the SARS- CoV strain, SARS- CoV-2 may possess a similar significant factors of mortality, respiratory failure, dura- neuroinvasive potential.5 tion of ventilator dependence, ICU admission, length of A study on cases with COVID-19 found that about ICU stay and length of hospital stay among patients with 36.4% of patients displayed neurological manifestations COVID-19 disease; (4) to determine if there is significant of the central nervous system (CNS) and peripheral difference between COVID-19 patients with neurological nervous system (PNS).6 The associated spectrum of symp- manifestations compared with those COVID-19 patients toms and signs were substantially broad such as altered without neurological manifestations in terms of mortality, mental status, headache, cognitive impairment, agita- respiratory failure, duration of ventilator dependence, tion, dysexecutive syndrome, seizures, corticospinal tract ICU admission, length of ICU stay and length of hospital signs, dysgeusia, extraocular movement abnormalities stay; and (5) to determine the likelihood of mortality, and myalgia.7–12 Several reports were published on neuro- respiratory failure and ICU admission, including the like- logical disorders associated with patients with COVID-19, lihood of longer duration of ventilator dependence and including cerebrovascular disorders, encephalopathy, length of ICU and hospital stay in COVID-19 patients with hypoxic brain injury, frequent convulsive seizures and neurological manifestations compared with those without inflammatory CNS syndromes like encephalitis, menin- neurological manifestations. gitis, acute disseminated encephalomyelitis and Guillain- Barre syndrome.7–16 However, the estimates of the Scope, limitations and delimitations occurrences of these manifestations were based on studies The study will include confirmed cases of COVID-19 from with a relatively small sample size. Furthermore, the the 37 participating institutions in the Philippines. Every current description of COVID-19 neurological features country has its own healthcare system, whose level of devel- are hampered to some extent by exceedingly variable opment and strategies ultimately affect patient outcomes. reporting; thus, defining causality between this infection Thus, the results of this study cannot be accurately gener- and certain neurological manifestations is crucial since alised to other settings. In addition, patients with ages ≤18 this may lead to considerable complications.17 An Italian years will be excluded in from this study. These younger observational study protocol on neurological manifesta- patients may have different characteristics and outcomes; tions has also been published to further document and therefore, yielded estimates for adults in this study may corroborate these findings.18 not be applicable to this population subgroup. More- Epidemiological data on the proportions and spectrum over, this study will collect data from the patient records of non- respiratory symptoms and complications may be of patients with COVID-19; thus, data from patients with essential to increase the recognition of clinicians of the mild symptoms who did not go to the hospital and those possibility of COVID-19 infection in the presence of other who had spontaneous resolution of symptoms despite symptoms, particularly neurological manifestations. true infection with COVID-19 are unobtainable. With this information, the probabilities of diagnosing http://bmjopen.bmj.com/ COVID-19 disease may be strengthened depending on the presence of certain neurological manifestations. METHODOLOGY Furthermore, knowledge of other unrecognised symp- To improve the quality of reporting of this study, the toms and complications may allow early diagnosis that guidelines issued by the Strengthening the Reporting of Observational Studies in Epidemiology Initiative will be may permit early institution of personal protective equip- 19 ment and proper contact precautions. Lastly, the pres- followed. ence of neurological manifestations may be used for Study design estimating the risk of certain important clinical outcomes on September 29, 2021 by guest. Protected copyright. The study will be conducted using a retrospective cohort for better and well-informed
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