Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to gather information to answer questions about the Coronavirus Disease 2019 (COVID-19) which is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. This study will collect information and biological specimens from participants who have been tested for the SARS-CoV-2 infection. By doing this study, the investigators hope to learn important new information about SARS-CoV-2 infections and the potentially severe outcomes of COVID-19 to find better ways to manage and treat it in the future. The investigators also hope to learn what makes some people more susceptible to infection to help better inform Veterans on how to reduce their risk of infection. This study also involves the development and maintenance of a participant registry, a data repository, and a biorepository for future research.

Detailed Description
-----------------
The objective of the study is to answer key research questions about the SARS-CoV-2 infection and COVID-19 natural history, clinical outcomes, and the development of immunity while also gathering biospecimens for future study as questions emerge about this new pathogen. The study is an observational cohort study of Veterans that is designed to gather longitudinal data on the epidemiology, virology, immunology, and clinical characteristics of the SARS-CoV-2 infection and COVID-19 disease during this early pandemic period while remaining flexible to the evolving needs of the Veterans Health Administration (VHA) system and emerging scientific questions. The study will enroll Veterans with and without SARS-CoV-2 infection in the inpatient, outpatient, and Community Living Center (CLC) extended care settings. Study procedures include questionnaires, clinical data abstraction from VHA electronic health records, and biological sampling. A key contribution of this study is to establish a research clinical and laboratory data repository and related research specimen repository, and participant registry for future studies of COVID-19, which is a newly emerging pandemic disease, and other health conditions. Finally, a long-term goal of this study is to provide the lessons learned from this COVID-19 pandemic to better anticipate and manage pandemics in the future for VHA and the general population. There are 4 primary aims to this study: (1) identify patterns of SARS-CoV-2 viral shedding from multiple body sites in inpatient Veterans with COVID-19 infection during hospitalization through 28 days of follow-up; (2) characterize development of immunity among inpatient and outpatient Veterans with COVID-19 from the first VHA encounter through 24 months; (3) determine predictors of infection and disease course, severity and related death among inpatient and outpatient Veterans with and without SARS-CoV-2 infection and/or COVID-19 disease over 24 months; and (4) determine individual and health-facility-level risk factors for infection (including asymptomatic infection) with SARS-CoV-2 among Veterans at high risk for COVID-19 disease who are living in VHA Community Living Centers. Veterans are likely to be substantially affected by COVID-19 due to a high prevalence of risk factors for severe COVID-19 disease. Understanding demographic, medical, and social factors that confer risk for severe COVID-19 disease is critical for improving care for Veterans with COVID-19. Characterizing viral shedding of SARS-CoV-2 infection during COVID-19 illness may yield important insight about factors that affect SARS-CoV-2 transmission. Characterizing the development of immunity among persons with COVID-19 is foundational to developing effective vaccines against the disease. Better understanding transmission risk and risk factors in the setting of VHA Community Living Centers will help prevent future infections.

Official Title
-----------------
CSP #2028 - Epidemiology, Immunology and Clinical Characteristics of COVID-19 (EPIC3) Within the Veterans Health Administration

Conditions
-----------------
SARS-CoV-2, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible inpatient cohort participants include Veterans with confirmed, or suspected, or unsuspected COVID-19 who receive inpatient care at VHA facilities Eligible outpatient cohort participants include Veterans who seek care in (1) VA medical center emergency departments, (2) VA medical center urgent care clinics, or (3) VA medical center COVID-19-specific testing sites, and who are tested for SARS-CoV-2 but do not require hospital admission at the time of evaluation Eligible Community Living Center cohort participants include all residents who reside in VA medical center-operated Community Living Centers Exclusion Criteria: Veterans without a legally authorized representative who are unable to provide consent Potential participants who are not Veterans Veterans who are VHA employees, students, or prisoners Veterans who are illiterate or have limited or no English language proficiency

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inpatient Cohort<br>COVID-19-positive or -suspected inpatients: Eligible inpatient cohort participants include Veterans who receive inpatient care at VHA facilities and are tested for SARS-CoV-2. Members of this inpatient cohort include those with and without SARS-CoV-2 infection. | |
| Outpatient Cohort<br>COVID-19-positive or -suspected outpatients: Eligible outpatient cohort participants include Veterans who seek care in (1) VA medical center emergency departments, (2) VA medical center urgent care clinics, or (3) VA medical center COVID-19-specific testing sites, and who are tested for SARS-CoV-2 but do not require hospital admission at the time of evaluation. Members of this outpatient cohort include those with and without SARS-CoV-2 infection. | |
| Community Living Center Cohort<br>Community Living Center residents: Eligible Community Living Center cohort participants include all residents who reside in VA medical center-operated Community Living Centers. Members of this Community Living Center cohort include those with and without SARS-CoV-2 infection. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Status Change | Mortality | Day 0 (enrollment) through 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral shedding | SARS-CoV-2 RNA from respiratory or gastrointestinal sampling sites | Day 0 (enrollment) through 6 months | 
| Immunity | SARS-CoV-2 IgM and IgG serum antibody titers | Day 0 (enrollment) through 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infectious disease, Chronic diseases, Critical care, Cohort, Epidemiologic, Observational, Prospective, Specimen banking, SARS-CoV-2, COVID-19