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COVID-19NCT04658121

SARS-CoV-2/COVID-19 Prevalence Study

An observational study of COVID-19, run by COVID-19 Prevention Network at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 2 months and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
How many people
26,211 participants
Where
15 sitesin 2 countries
Study dates
4 Feb 2021to 12 Aug 2021
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 months and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States14 sites
  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308

  • Children's Hospital Colorado CRS

    Aurora, Colorado, 80045

  • John's Hopkins CRS

    Baltimore, Maryland, 21218

  • UIC Project Wish CRS

    Chicago, Illinois, 60612

  • Cincinnati CRS

    Cincinnati, Ohio, 45229

  • Baylor College of Medicine

    Houston, Texas, 77030

  • U of Miami, IDRU at Jackson Memorial Hospital CRS

    Miami, Florida, 33136

  • New Orleans Adolescent Trials Unit CRS

    New Orleans, Louisiana, 70118

  • Harlem Prevention

    New York, New York, 10027

  • Physicians & Surgeons CRS

    New York, New York, 10032

  • Bronx Prevention Center

    New York, New York, 10451

  • New Jersey Medical School CRS

    Newark, New Jersey, 07103

  • Penn Prevention CRS

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

Other trials in United States

Puerto Rico1 site
  • St. Louis University VTEU-CAIMED-PHSU

    Ponce

Other trials in Puerto Rico

About this study

Official title: SARS-CoV-2 Prevalence Study

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.

Read the 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.

Conditions
COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04658121
Study groupRoleWhat they receive
Senior Living FacilitiesAdults residing in senior living facilities (nursing homes, assisted or independent living facilities)
Outpatient Healthcare FacilitiesAdults attending outpatient healthcare in neighborhoods of selected research sites
General CommunitiesAdults and children (>2 months of age) in neighborhoods of selected research sites

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To Estimate the Prevalence of SARS-CoV-2 IgG Seropositivity Among Individuals in Communities Surrounding Selected NIAID Clinical Research Sites

    Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample for laboratory analysis.

    Measured: Baseline

Secondary outcomes (19)
  1. To Estimate Prevalence of SARS-CoV-2 Infection Based on Results of SARS-CoV-2 RNA Testing

    Prevalence of active SARS-CoV-2 infection from the enrolled cohorts who provided a nasal swab sample for PCR laboratory analysis.

    Measured: Baseline

  2. To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Presence of Symptoms Consistent With COVID-19

    Prevalence of active SARS-CoV-2 infection from the enrolled cohorts who provided a nasal swab sample, had a result from PCR laboratory analysis, and reported any symptom consistent with COVID-19 (symptoms include fever, headache, cough, congestion, etc...).

    Measured: Baseline

  3. To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Absence of Symptoms Consistent With COVID-19

    Prevalence of active SARS-CoV-2 infection from the enrolled cohorts who provided a nasal swab sample, had a result from PCR laboratory analysis, and reported no symptoms consistent with COVID-19 (symptoms include fever, headache, cough, congestion, etc...).

    Measured: Baseline

  4. To Estimate Seroprevalence of SARS-CoV-2 Among Those Without Past or Current Symptoms Consistent With COVID-19

    Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample, had a result from laboratory analysis, and reported no past or current symptoms consistent with COVID-19 (symptoms include fever, headache, cough, congestion, etc...).

    Measured: Baseline

  5. To Estimate Seroprevalence of SARS-CoV-2 Among Those With no Prior Positive SARS-CoV-2 Testing, But Who Report Close Contact With Confirmed or Presumed Cases

    Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample, had a result from laboratory analysis, and reported no prior positive SARS-CoV-2 testing but did report close contact with confirmed or presumed cases.

    Measured: Baseline

  6. To Estimate Seroprevalence of SARS-CoV-2 Among Those With History of Co-morbid Medical Conditions

    Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample, had a result from laboratory analysis, and reported any co-morbid medical condition (which includes asthma, hypertension, diabetes, etc...)

    Measured: Baseline

  7. To Assess Association Between Age and SARS-CoV-2 Infection and/or Seroprevalence

    Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample and had a result from laboratory analysis. Results are reported by site and by age group (0-17, 18-39, 40-59, 60+).

    Measured: Baseline

  8. To Assess Association Between Sex and SARS-CoV-2 Infection and/or Seroprevalence

    Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample and had a result from laboratory analysis. Results are reported by site and by sex.

    Measured: Baseline

  9. To Assess Association Between Race and SARS-CoV-2 Infection and/or Seroprevalence

    Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample and had a result from laboratory analysis. Results are reported by site and by racial category. The racial group "Other" includes responses of Other, Multiple Races, Asian, Native Hawaiian or other Pacific Islander, American Indian or Alaskan Native, as well as don't know/not sure or prefer not to answer.

    Measured: Baseline

  10. To Assess Association Between Ethnicity and SARS-CoV-2 Infection and/or Seroprevalence

    Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample, had a result from laboratory analysis, and had a non-missing ethnicity response. Results are reported by site and by ethnicity.

    Measured: Baseline

  11. To Assess Association Between Education and SARS-CoV-2 Infection and/or Seroprevalence

    Prevalence of SARS-CoV-2 infection and/or antibodies from the enrolled cohorts who provided a blood serum, DBS, or nasal swab sample and had a result from laboratory analysis. Results are reported by site and by education level. The category of "College Degree" includes college, univesity or post-graduate degree. The category of "Middle School or Under" includes middle School (6th-8th grade), elementary school (1st-5th grade), kindergarten, pre-kindergarten, or no formal education.

    Measured: Baseline

  12. To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those With Active COVID-19

    The purpose of this outcome is to estimate the total number of people in each city's catchment area that had active COVID-19, using data collected January-July 2021 from the CoVPN5002 study and using 2020 US Census Data given the zip codes from defined recruitment catchment area at each city.

    Measured: Baseline

  13. To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those Who Have Serologic Evidence of Recent and/or Past SARS-CoV-2 Infection

    The purpose of this outcome is to estimate the total number of people in each city's catchment area who have serologic evidence of recent and/or past SARS-CoV-2 infection, using data collected January-July 2021 from the CoVPN5002 study and using 2020 US Census Data given the zip codes from defined recruitment catchment area at each city.

    Measured: Baseline

  14. To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those Who Have Negative RNA and Serologic SARS-CoV-2 Tests

    The purpose of this outcome is to estimate the total number of people in each city's catchment area that have negative RNA and serologic SARS-CoV-2 tests, using data collected January-July 2021 from the CoVPN5002 study and using 2020 US Census Data given the zip codes from defined recruitment catchment area at each city.

    Measured: Baseline

  15. To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Face-masking

    Proportions of participants who responded "All of the time" or Most of the time" on a 5-point Likert Scale for a question on whether they wore a face mask in public spaces.

    Measured: Baseline

  16. To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Six-feet Distancing

    Proportions of participants who responded "All of the time" or Most of the time" on a 5-point Likert Scale for a question on whether they maintained six feet of distance from others in public spaces.

    Measured: Baseline

  17. To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Avoiding Public Spaces

    Proportions of participants who responded "Never" or "Almost Never" on a 5-point Likert Scale for a question on whether they spend time in public spaces, gatherings, and crowds.

    Measured: Baseline

  18. To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Vaccine Willingness

    Proportions of participants who responded "Very likely", "Likely", or "Already Received" for a question on their likelihood to receive an approved vaccine for COVID-19.

    Measured: Baseline

  19. To Assess Performance Characteristics of PCR-based and Serologic SARS-CoV-2 Tests Using Saliva Samples

    Concordance between saliva and nasal SARS-CoV-2 PCR results among a sub-sample of participants.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2020
  2. Study start4 Feb 2021
  3. Primary completion12 Aug 2021
  4. Study completion12 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
26,211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04658121
Sponsor's protocol ID
CoVPN 5002
Status last verified
Sep 2025
First submitted
19 Nov 2020
Last updated
16 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by COVID-19 Prevention Network at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Estimate the Prevalence of SARS-CoV-2 IgG Seropositivity Among Individuals in Communities Surrounding Selected NIAID Clinical Research Sites (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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