Seroprevalence of Antibodies against SARS-CoV-2 in a population of COVID-19 survivors in Nigeria (The SAS/COVID-19 study)

Project background, context, and needs addressed Since December 2019, the world has battled an invisible enemy, in form of the novel coronavirus, also known as the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). As of April 26, 2020, this virus has infected over 2.8 million people in 185 countries, causing over 200,000 deaths. Africa in general and indeed Nigeria, in particular, has not been spared by the ravaging pandemic, with the West African nation reporting over 1,182 cases and 35 fatalities as of April 26, 2020. With no approved therapeutic agent for COVID-19 and vaccine development over a year away from completion, the world has turned to several alternatives to combat this rapidly evolving virus in the short term; and one such alternative is the possibility of neutralizing antibodies which develop following viral infection and have been hypothesized to confer immunity against subsequent infections in the short- or possibly long-term. Through our study, we aim to determine the Seroprevalence of these IgM and IgG antibodies in a population of COVID-19 survivors, thus paving the way for subsequent studies on the efficacy of these antibodies as therapeutic options in an African context. Aims or research questions being addressed Through our study, we aim to establish the seroprevalence of IgM and IgG antibodies against the SARS-CoV-2 in a population of COVID-19 survivors in Nigeria, and in so doing, we aim to answer the following questions: 1. What proportion of Nigerian COVID-19 survivors in our sample population has developed antibodies to the deadly virus? 2. What are the titre ranges of these antibodies in the study population? 3. Are there any correlations between antibody titre and clinical symptoms? Study design Ethical Approval: Ethical approval for the study will be obtained from the Institutional Review Board of Redeemers University and the Ministries of Health in Lagos, Oyo and Osun states, Nigeria. Study population & Sample Collection: For this study, we would be collecting blood samples from 400 recent COVID-19 survivors in three states in Nigeria, including Lagos (the epicentre of the Nation's outbreak), Oyo and Osun states. Each study participant will be contacted with permission from the State Ministries of Health and/or the Nigerian Centre for Disease Control (NCDC). Each study participant will be asked to complete an informed consent form prior to enrolment and also respond to a form containing questions on socio-demographic information (age, sex, occupation, etc) as well as information on clinical symptoms relating to the SARS-CoV-2 infection, in order to grade participants into asymptomatic, mildly symptomatic and severely symptomatic at the point of diagnosis. Serological testing: For our study, we have designed a staged serological surveillance study for SARS-CoV-2 antibodies, consisting of an initial screening step for the anti-SARS-CoV-2 IgG and IgM using the Enzyme Linked Immunosorbent Assay (ELISA) test kits, after which borderline and reactive samples will be confirmed for the presence of antibodies using Plaque Reduction Neutralization Tests (PRNT). Statistical analysis: This will be done using the IBM Statistical Package for the Social Sciences (SPSS) software version 25 (IBM, USA). Approach used to maximise impact of research output, to improve health and the research community A significant strength of this study is its potential to inform treatment policy for COVID-19 patients going forward. To the best of my knowledge, while there have been a number of study investigating the presence of neutralising antibodies in COVID-19 patients and survivors in Europe and North America, there has been no study of this kind launched and currently on-going in Nigeria and the entire West African sub-region, making this novel and of direct application to the African population. Through strong partnerships with the Nigeria Centre for Disease Control, the findings of this study if positive, will be translated into bedside treatment at the COVID-19 isolation centres across the country and possibly within the West African sub-region. By publishing our findings in an open access journal, we would also be making these accessible to the global audience of researchers working towards combating the deadly pandemic. We would also be submitting our report to the World Health Organisation (WHO) Country Office in Nigeria for integration into the WHO global action framework against COVID-19. Expected outcomes Data from this study will show the seroprevalence of anti-SARS-Cov-2 antibodies among survivors in Nigeria. It will associate antibodies with protection and report the ranges of antibody titres in the study population. It will also form the baseline data for vaccine production and the assessment of clinical trials in the Nigerian population. We expect the following outcomes from our study: 1) A significant proportion of Nigerian COVID-19 survivors would have neutralising antibodies against SARS-CoV-2 in their serum 2) Antibody titres in the study population would be high 3) There is some correlation between antibody titre and clinical symptoms Your role in the project I am the Principal Investigator of the study and would be leading a dynamic team of co-investigators and research associates including: phlebotomists, biostatisticians, virologists, clinicians and medical laboratory scientists. My specific roles would include the following: 1) Preparing and submitting grant and funding applications 2) Preparing and submitting applications for ethical approval 3) Preparing and submitting applications for collaborations with the Nigerian Centre for Disease Control (NCDC) 4) Co-ordinating the study participant recruitment and sample collection stages 5) Co-ordinating the serological testing stages 6) Interpreting all study results and making informed inferences or conclusions 7) Preparing manuscripts of study results for publication 8) Preparing final study report for submission to the Royal Society of Tropical Medicine & Hygiene 9) Liaising with all stakeholders including study collaborators, funding agencies (RSTMH) and research supervisor