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SARS-CoV-2/COVID-19 Prevalence Study

Sponsor
COVID-19 Prevention Network (Other)
Overall Status
Completed
CT.gov ID
NCT04658121
Collaborator
(none)
26,741
Enrollment
15
Locations
6.2
Actual Duration (Months)
1782.7
Patients Per Site
287.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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 =

    1. outpatient healthcare facilities (n = 500)

    2. 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    26741 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    SARS-CoV-2 Prevalence Study
    Actual Study Start Date :
    Feb 4, 2021
    Actual Primary Completion Date :
    Aug 12, 2021
    Actual Study Completion Date :
    Aug 12, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Senior Living Facilities

    Adults residing in senior living facilities (nursing homes, assisted or independent living facilities)
    Outpatient Healthcare Facilities

    Adults attending outpatient healthcare in neighborhoods of selected research sites
    General Communities

    Adults and children (>2 months of age) in neighborhoods of selected research sites

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing [Baseline]

    2. To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19 [Baseline]

    3. To estimate seroprevalence of SARS-CoV-2 [Baseline]

      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

    4. 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. [Baseline]

      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.

    5. To estimate potential size of populations for referral to COVID-19 prevention and treatment studies [Baseline]

    6. To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 through a study questionnaire [Baseline]

    7. To assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva samples [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Months and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Colorado CRS Aurora Colorado United States 80045
    2 U of Miami, IDRU at Jackson Memorial Hospital CRS Miami Florida United States 33136
    3 The Ponce de Leon Center CRS Atlanta Georgia United States 30308
    4 UIC Project Wish CRS Chicago Illinois United States 60612
    5 New Orleans Adolescent Trials Unit CRS New Orleans Louisiana United States 70118
    6 John's Hopkins CRS Baltimore Maryland United States 21218
    7 New Jersey Medical School CRS Newark New Jersey United States 07103
    8 Harlem Prevention New York New York United States 10027
    9 Physicians & Surgeons CRS New York New York United States 10032
    10 Bronx Prevention Center New York New York United States 10451
    11 Cincinnati CRS Cincinnati Ohio United States 45229
    12 Penn Prevention CRS Philadelphia Pennsylvania United States 19104
    13 University of Pittsburgh Pittsburgh Pennsylvania United States 15260
    14 Baylor College of Medicine Houston Texas United States 77030
    15 St. Louis University VTEU-CAIMED-PHSU Ponce Puerto Rico

    Sponsors and Collaborators

    • COVID-19 Prevention Network

    Investigators

    • Study Chair: Jessica Justman, MD, Departments of Epidemiology and Medicine, Columbia University

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    COVID-19 Prevention Network
    ClinicalTrials.gov Identifier:
    NCT04658121
    Other Study ID Numbers:
    • CoVPN 5002
    First Posted:
    Dec 8, 2020
    Last Update Posted:
    Oct 4, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Oct 4, 2021