NCT04658121

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,741

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 4, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2021

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

6 months

First QC Date

November 19, 2020

Last Update Submit

September 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • To estimate the prevalence of SARS-CoV-2 IgG seropositivity among individuals in communities surrounding selected NIAID clinical research sites

    Baseline

Secondary Outcomes (7)

  • To estimate prevalence of SARS-CoV-2 infection based on results of SARS-CoV-2 RNA testing

    Baseline

  • To estimate prevalence of SARS-CoV-2 infection by presence versus absence of symptoms consistent with COVID-19

    Baseline

  • To estimate seroprevalence of SARS-CoV-2

    Baseline

  • 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.

    Baseline

  • To estimate potential size of populations for referral to COVID-19 prevention and treatment studies

    Baseline

  • +2 more secondary outcomes

Study Arms (3)

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

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Children's Hospital Colorado CRS

Aurora, Colorado, 80045, United States

Location

U of Miami, IDRU at Jackson Memorial Hospital CRS

Miami, Florida, 33136, United States

Location

The Ponce de Leon Center CRS

Atlanta, Georgia, 30308, United States

Location

UIC Project Wish CRS

Chicago, Illinois, 60612, United States

Location

New Orleans Adolescent Trials Unit CRS

New Orleans, Louisiana, 70118, United States

Location

John's Hopkins CRS

Baltimore, Maryland, 21218, United States

Location

New Jersey Medical School CRS

Newark, New Jersey, 07103, United States

Location

Harlem Prevention

New York, New York, 10027, United States

Location

Physicians & Surgeons CRS

New York, New York, 10032, United States

Location

Bronx Prevention Center

New York, New York, 10451, United States

Location

Cincinnati CRS

Cincinnati, Ohio, 45229, United States

Location

Penn Prevention CRS

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

St. Louis University VTEU-CAIMED-PHSU

Ponce, Puerto Rico

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood collection, nasal mid-turbinate swab, and saliva

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jessica Justman, MD

    Departments of Epidemiology and Medicine, Columbia University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 8, 2020

Study Start

February 4, 2021

Primary Completion

August 12, 2021

Study Completion

August 12, 2021

Last Updated

October 4, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations