SARS-CoV-2/COVID-19 Prevalence Study

COVID-19 Clinical Trial

Official title:

SARS-CoV-2 Prevalence Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04658121
• Other study ID #: CoVPN 5002
• Status: Completed
• Start date: February 4, 2021
• Est. completion date: August 12, 2021

Study information

• Verified date: September 2021
• Source: COVID-19 Prevention Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The COVID-19 Prevention Network (CoVPN) is doing a study to estimate the number of people who have or have had the SARS-CoV-2 virus in different communities in the United States. This study is being done to help determine the best places to perform future research studies that will test new drugs for treatment or prevention of COVID-19.

Description:

Design:

Cross-sectional surveys of (1) adults residing in senior living facilities and attending outpatient healthcare facilities, and (2) the general population in each selected research site community.

Population:

1. Adults residing in senior living facilities (nursing homes, assisted or independent living facilities) and 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, up to 3,920 individuals will be enrolled from one, two, or all three of the following populations (must include at least community venues):

1. senior living facilities (nursing homes, assisted or independent living facilities; n = 500)

2. outpatient healthcare facilities (n = 500)

3. community venues distributed across four age categories (0-17, 18-39, 40-59, 60+ years) (n = 730 per stratum or 2920)

Total sample size = 3,920 x up to 20 clinical research sites

Study Duration:

Approximately sixteen (16) months for overall project. Two (2) months for protocol development and institutional review board (IRB) approval, followed by:

1. Facility-based surveys: 12 months (3 months for site preparation and initiation, 3 months for enrollment/sample collection, 4 months for shipping and laboratory testing*, 2 months for close-out), concurrent with

2. Time-location sampling (TLS) surveys: 14 months (3 months for site preparation and initiation, 6 months for enrollment/sample collection, 6 months for shipping and laboratory testing*, 2 months for close-out)

• Some activities will be concurrent with enrollment

Study Location:

Catchment areas surrounding US-based Clinical Research Sites (CRSs) of the: HIV Prevention Trials Network (HPTN), HIV Vaccine Trials Network (HVTN), Infectious Diseases Clinical Research Consortium (IDCRC), International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT), and the AIDS Clinical Trials Group (ACTG); to be specified in the Site Announcement Memo

Study Methods:

Blood collection for SARS-CoV-2 antibody testing and characterization of the serologic response to SARS-CoV-2 infection; nasal mid-turbinate swab collection for SARS-CoV-2 RNA testing; collection of saliva in a subset of participants to evaluate the performance of diagnostic SARS-CoV-2 assays using these matrices; administration of tablet-based survey. Medical records abstraction for senior living facility participants who are unable to respond to the study survey.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26741
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months and older

Eligibility

Inclusion Criteria:

Adults residing in senior living facilities or attending outpatient healthcare facilities:

• At least 18 years of age

• Willing and able to provide informed consent or consent has been provided by legal representative (for those with mental incapacity in senior living facilities)

• Recruited from a selected facility

Adults and children from select neighborhoods of research site communities:

• Adults and children > 2 months of age

• For individuals < 18 years old, a guardian must be present (in person or by phone for those 15 - 17 years old)

• Willing and able to provide consent (or assent for individuals 7-17 years old, parent/guardian will provide consent for all minors)

• Recruited from a selected venue

Exclusion Criteria:

• Previous enrollment in this study, either from the same or another CRS community.

• Any condition that, in the opinion of the study staff, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Puerto Rico	St. Louis University VTEU-CAIMED-PHSU	Ponce
United States	The Ponce de Leon Center CRS	Atlanta	Georgia
United States	Children's Hospital Colorado CRS	Aurora	Colorado
United States	John's Hopkins CRS	Baltimore	Maryland
United States	UIC Project Wish CRS	Chicago	Illinois
United States	Cincinnati CRS	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	U of Miami, IDRU at Jackson Memorial Hospital CRS	Miami	Florida
United States	New Orleans Adolescent Trials Unit CRS	New Orleans	Louisiana
United States	Bronx Prevention Center	New York	New York
United States	Harlem Prevention	New York	New York
United States	Physicians & Surgeons CRS	New York	New York
United States	New Jersey Medical School CRS	Newark	New Jersey
United States	Penn Prevention CRS	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
COVID-19 Prevention Network

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites		Baseline
Secondary	To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing		Baseline
Secondary	To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19		Baseline
Secondary	To estimate seroprevalence of SARS-CoV-2	Among: Those without past or current symptoms consistent with COVID-19; Those with no prior positive SARS-CoV-2 testing, but who report close contact with confirmed or presumed cases; Those with history of co-morbid medical conditions	Baseline
Secondary	To assess association between demographic, clinical and social factors with SARS-CoV-2 infection and seroprevalence, with particular interest in racial and ethnic health disparities.	Logistic regression using survey weights will be used to infer associations between the hypothesized socioeconomic, demographic and clinical predictors of SARS-CoV-2 infection and seroprevalence.	Baseline
Secondary	To estimate potential size of populations for referral to COVID-19 prevention and treatment studies		Baseline
Secondary	To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 through a study questionnaire		Baseline
Secondary	To assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva samples		Baseline

External Links

•   CDC Coronavirus Disease 2019 (COVID-19): Groups at Higher Risk for Severe Illness 2020 [updated 06/25/2020]
•   COVID-19 Nursing Home Data [Internet].2020 [cited 06/08/2020]