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Completed

NCT Number: NCT04658121

SARS-CoV-2/COVID-19 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

2 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Louis University VTEU-CAIMED-PHSU, Ponce, Puerto Rico

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About this study

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:

  • Adults residing in senior living facilities (nursing homes, assisted or independent living facilities) and attending outpatient healthcare facilities in neighborhoods of selected research sites
  • 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):

  • senior living facilities (nursing homes, assisted or independent living facilities; n = 500)
  • outpatient healthcare facilities (n = 500)
  • 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:

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

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

Secondary outcomes

  1. To Estimate Prevalence of SARS-CoV-2 Infection Based on Results of SARS-CoV-2 RNA Testing

    Time frame: Baseline

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

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

    Time frame: Baseline

    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...).

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

    Time frame: Baseline

    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...).

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

    Time frame: Baseline

    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...).

  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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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...)

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

    Time frame: Baseline

    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+).

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

  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

    Time frame: Baseline

    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.

  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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

COVID-19 Prevention Network

Network

Registry information

Official study title

SARS-CoV-2 Prevalence Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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