Study Details

Protocol Status: Enrolling
Study Purpose:

To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites

Study Design:

Cross-sectional surveys of (1) nursing home and outpatient healthcare facilities, and (2) the general population in each selected research site community through time-location sampling

Study Population:

1) Adults residing in nursing homes or attending outpatient healthcare facilities in neighborhoods of selected research sites
2) Adults and children (> 2 months of age) in neighborhoods of selected research sites

Study Size:

For each research site, 3,920 individuals will be enrolled from:
1) nursing homes/assisted living facilities (n = 500) and outpatient healthcare facilities (n = 500), and
2) community surveys distributed across four age strata (0-17, 18-39, 40-59, 60+ years) (n = 730 per stratum or 2920)

Total sample size = 3,920 x approximately 20-25 clinical research sites

Study Duration:

Approximately one (1) year for overall project. Two (2) months for protocol development and institutional review board (IRB) approval, followed by:
1) Facility-based surveys: 9 months (2 months for site preparation and initiation, 1 month for enrollment/sample collection, 4 months for shipping and laboratory testing, 2 months for close-out), concurrent with
2) Time-location sampling (TLS) surveys: 12 months (2 months for site preparation and initiation, 2 months for enrollment/sample collection, 6 months for shipping and laboratory testing, 2 months for close-out)

Treatment Regimen:

N/A

Primary Objectives:

To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites

Secondary Objectives:

1) To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing
2) To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19
3) To estimate seroprevalence of SARS-CoV-2 among:
a. Those without past or current symptoms consistent with COVID-19
b. Those with no prior positive SARS-C0V-2 testing, but who report close contact with confirmed or presumed cases
c. Those with history of co-morbid medical conditions
4) To assess association between demographic, clinical and social factors with SARS-CoV-2 infection and seroprevalence
5) To estimate potential size of populations for referral to COVID-19 prevention and treatment studies
6) To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19
7) To assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva and/or oral fluid samples and DBS samples

Other Objectives:

1) To model epidemiologic impact over time of COVID-19 in the study communities, including modeled incidence and prevalence of COVID-19
2) To conduct laboratory testing in a subset of participants to characterize SARS-CoV-2 viruses and the host response to SARS-CoV-2 infection; this may include testing for anti-SARS-CoV-2 IgM antibodies. This testing may also include phylogenetic analysis and analysis of co-infections with other viruses, including viruses that impact the specificity of SARS-CoV-2 serologic assays.