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Trial record 1 of 1 for:    NCT04658121
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SARS-CoV-2/COVID-19 Prevalence Study

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ClinicalTrials.gov Identifier: NCT04658121
Recruitment Status : Enrolling by invitation
First Posted : December 8, 2020
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
COVID-19 Prevention Network

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
COVID-19

Detailed Description:

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

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)

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 and/or oral fluid and dried blood spot samples (DBS) 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 healthcare facility participants.

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Study Type : Observational
Estimated Enrollment : 3920 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: SARS-CoV-2 Prevalence Study
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Group/Cohort
Nursing Homes
Adults residing in nursing homes.
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.



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

Secondary Outcome Measures :
  1. To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing [ Time Frame: Baseline ]
  2. To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19 [ Time Frame: Baseline ]
  3. To estimate seroprevalence of SARS-CoV-2 [ Time Frame: Baseline ]
    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.

  4. To assess correlation between demographic, clinical and social factors with SARS-CoV-2 infection and seroprevalence [ Time Frame: Baseline ]
  5. To estimate potential size of populations for referral to COVID-19 prevention and treatment studies [ Time Frame: Baseline ]
  6. To assess knowledge, attitudes, and behavior about SARS-CoV-2 and COVID-19 through a study questionnaire [ Time Frame: Baseline ]
  7. To compare performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva and/or oral fluid and DBS samples [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
Serum, nasal swab, and saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  • Adults residing in nursing homes or attending outpatient healthcare facilities in neighborhoods of selected research sites.
  • Adults and children (>2 month of age) in neighborhoods of selected research sites.
Criteria

Inclusion Criteria:

  • Adults residing in nursing homes/assisted 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)
    • 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
    • Willing and able to provide consent (or assent for individuals < 18 years, parent/guardian will provide consent)
    • Resident of the CRS catchment area or recruited from a selected venue

Exclusion Criteria:

  • Prior or current enrollment in any interventional COVID-19 clinical trial, including studies involving prophylactic, therapeutic or immune modulating agents.
  • 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 objective.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658121


Locations
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United States, Colorado
Children's Hospital Colorado CRS
Aurora, Colorado, United States, 80045
United States, Florida
U of Miami, IDRU at Jackson Memorial Hospital CRS
Miami, Florida, United States, 33136
United States, Georgia
The Ponce de Leon Center CRS
Atlanta, Georgia, United States, 30308
United States, Illinois
UIC Project Wish CRS
Chicago, Illinois, United States, 60612
United States, Louisiana
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, United States, 70118
United States, Maryland
John's Hopkins CRS
Baltimore, Maryland, United States, 21218
United States, New Jersey
New Jersey Medical School CRS
Newark, New Jersey, United States, 07103
United States, New York
Harlem Prevention
New York, New York, United States, 10027
Bronx Prevention Center
New York, New York, United States, 10451
United States, North Carolina
Chapel Hill CRS
Chapel Hill, North Carolina, United States, 37034
United States, Ohio
Cincinnati CRS
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Penn Prevention CRS
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Puerto Rico
St. Louis University VTEU-CAIMED-PHSU
Ponce, Puerto Rico
Sponsors and Collaborators
COVID-19 Prevention Network
Investigators
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Study Chair: Jessica Justman, MD Departments of Epidemiology and Medicine, Columbia University
Additional Information:
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Responsible Party: COVID-19 Prevention Network
ClinicalTrials.gov Identifier: NCT04658121    
Other Study ID Numbers: CoVPN 5002
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No