Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05764083 |
| Other study ID # |
2028 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 22, 2020 |
| Est. completion date |
September 30, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
