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SARS-CoV-2/COVID-19 Prevalence Study

18 de junho de 2026 atualizado por: COVID-19 Prevention Network

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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

26211

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Children's Hospital Colorado CRS
    • Florida
      • Miami, Florida, Estados Unidos, 33136
        • U of Miami, IDRU at Jackson Memorial Hospital CRS
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30308
        • The Ponce de Leon Center CRS
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • UIC Project Wish CRS
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70118
        • New Orleans Adolescent Trials Unit CRS
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21218
        • John's Hopkins CRS
    • New Jersey
      • Newark, New Jersey, Estados Unidos, 07103
        • New Jersey Medical School CRS
    • New York
      • New York, New York, Estados Unidos, 10027
        • Harlem Prevention
      • New York, New York, Estados Unidos, 10032
        • Physicians & Surgeons CRS
      • New York, New York, Estados Unidos, 10451
        • Bronx Prevention Center
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Cincinnati CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Penn Prevention CRS
      • Pittsburgh, Pennsylvania, Estados Unidos, 15260
        • University of Pittsburgh
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Baylor College of Medicine
  • Porto Rico
      • Ponce, Porto Rico
        • St. Louis University VTEU-CAIMED-PHSU

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

2 meses e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra de Probabilidade

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
To Estimate the Prevalence of SARS-CoV-2 IgG Seropositivity Among Individuals in Communities Surrounding Selected NIAID Clinical Research Sites
Prazo: Baseline
Prevalence of SARS-CoV-2 antibodies from the enrolled cohorts who provided a blood serum or DBS sample for laboratory analysis.
Baseline

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
To Estimate Prevalence of SARS-CoV-2 Infection Based on Results of SARS-CoV-2 RNA Testing
Prazo: Baseline
Prevalence of active SARS-CoV-2 infection from the enrolled cohorts who provided a nasal swab sample for PCR laboratory analysis.
Baseline
To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Presence of Symptoms Consistent With COVID-19
Prazo: 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...).
Baseline
To Estimate Prevalence of SARS-CoV-2 Infection Among Those Reporting Absence of Symptoms Consistent With COVID-19
Prazo: 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...).
Baseline
To Estimate Seroprevalence of SARS-CoV-2 Among Those Without Past or Current Symptoms Consistent With COVID-19
Prazo: 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...).
Baseline
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
Prazo: 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.
Baseline
To Estimate Seroprevalence of SARS-CoV-2 Among Those With History of Co-morbid Medical Conditions
Prazo: 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...)
Baseline
To Assess Association Between Age and SARS-CoV-2 Infection and/or Seroprevalence
Prazo: 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+).
Baseline
To Assess Association Between Sex and SARS-CoV-2 Infection and/or Seroprevalence
Prazo: 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.
Baseline
To Assess Association Between Race and SARS-CoV-2 Infection and/or Seroprevalence
Prazo: 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.
Baseline
To Assess Association Between Ethnicity and SARS-CoV-2 Infection and/or Seroprevalence
Prazo: 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.
Baseline
To Assess Association Between Education and SARS-CoV-2 Infection and/or Seroprevalence
Prazo: 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.
Baseline
To Estimate Potential Size of Populations for Referral to COVID-19 Prevention and Treatment Studies for Those With Active COVID-19
Prazo: 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.
Baseline
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
Prazo: 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.
Baseline
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
Prazo: 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.
Baseline
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Face-masking
Prazo: 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.
Baseline
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Six-feet Distancing
Prazo: 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.
Baseline
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Avoiding Public Spaces
Prazo: 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.
Baseline
To Assess Knowledge, Attitudes, and Behavior About SARS-CoV-2 and COVID-19 Through a Study Questionnaire: Vaccine Willingness
Prazo: 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.
Baseline
To Assess Performance Characteristics of PCR-based and Serologic SARS-CoV-2 Tests Using Saliva Samples
Prazo: Baseline
Concordance between saliva and nasal SARS-CoV-2 PCR results among a sub-sample of participants.
Baseline

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

COVID-19 Prevention Network

Investigadores

  • Cadeira de estudo: Jessica Justman, MD, Departments of Epidemiology and Medicine, Columbia University

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de fevereiro de 2021

Conclusão Primária (Real)

12 de agosto de 2021

Conclusão do estudo (Real)

12 de agosto de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

19 de novembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de dezembro de 2020

Primeira postagem (Real)

8 de dezembro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de junho de 2026

Última verificação

1 de setembro de 2025

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CoVPN 5002

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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