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SARS-CoV-2/COVID-19 Prevalence Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04658121
Recruitment Status : Completed
First Posted : December 8, 2020
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
COVID-19 Prevention Network

Study Description
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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) 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.

Study Design
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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 : February 4, 2021
Actual Primary Completion Date : August 12, 2021
Actual Study Completion Date : August 12, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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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 ]

    Among:

    1. Those without past or current symptoms consistent with COVID-19
    2. Those with no prior positive SARS-CoV-2 testing, but who report close contact with confirmed or presumed cases
    3. 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. [ Time Frame: 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 [ 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 assess performance characteristics of PCR-based and serologic SARS-CoV-2 tests using saliva samples [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
Blood collection, nasal mid-turbinate swab, and saliva

Eligibility Criteria
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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 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
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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
Physicians & Surgeons CRS
New York, New York, United States, 10032
Bronx Prevention Center
New York, New York, United States, 10451
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
  Study Documents (Full-Text)

Documents provided by COVID-19 Prevention Network:
Study Protocol and Informed Consent Form  [PDF] May 26, 2021

More Information
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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: October 4, 2021
Last Verified: September 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
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases