SARS-CoV-2/COVID-19 Prevalence Study

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

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
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.

Study Design

• 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

Groups and Cohorts

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.

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 [ 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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

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

More Information

Additional Information:

COVID-19 Nursing Home Data [Internet].2020 [cited 06/08/2020] 

CDC.Coronavirus Disease 2019 (COVID-19): Groups at Higher Risk for Severe Illness 2020 [updated 05/14/2020] 

• Responsible Party: COVID-19 Prevention Network
• ClinicalTrials.gov Identifier: NCT04658121
• Other Study ID Numbers: CoVPN 5002
• First Posted: December 8, 2020
• Last Update Posted: February 9, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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