Skip to main content
OpenTrials
Completed

NCT Number: NCT04342884

COVID-19 Community Research Partnership

The purpose of this research is to collect information about the North Carolina community's coronavirus exposures, symptoms, and health care visits due to the virus. Participation in this study will involve completing a daily questionnaire which covers participants coronavirus illness history or symptoms, health care seeking behaviors and treatments, contact with other sick people, and for health care workers, their use of personal protective equipment.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States

Loading trial locations.

About this study

Investigators will conduct a prospective, cohort study for SARS-CoV-2 infections among clients and health care workers of Wake Forest Baptist Health (WFBH). Investigators will conduct real-time syndromic respiratory disease surveillance and, for SARS-CoV-2 infections, calculate baseline seroprevalence and seroconversion rates, hazard risks from close contacts, estimate efficacy of personal protective equipment, and assess sequelae incidence. Investigators will utilize the COVID-19 Therapeutic Learning System, an Oracle developed self-reporting data collection system that can be easily modified to address these specific questions. Over the course of the study, volunteers will report daily exposures, risk reduction behaviors, and symptoms through a secure app on their smartphone, tablet, or computer. In addition to daily syndromic surveillance, at baseline and once every month after that we will use a serologic IgM/G test kit to identify infections and reinfections in volunteers and send results to the Oracle developed database. The areas covered by this study are experiencing community spread of COVID-19 but are early enough in the epidemic to capture potentially a significant number of seroconversions over the 12 months of the study. This surveillance model will be expanded to include the clients and health workers of other medical agencies in North Carolina and in other states.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All clients and health care worker of WFBH are eligible for enrollment.

Exclusion criteria

  • Health care workers who do not receive medical services through WFBH will not be enrolled.

Treatment and study plan

Primary outcomes

  1. Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina

    Time frame: baseline

    Percent of volunteers who are 2019-nCoV Ab test positive

  2. Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina

    Time frame: baseline

    Percent of volunteers who are 2019-nCoV Ab test positive

Secondary outcomes

  1. Cumulative incidence of SARS-CoV-2 infection

    Time frame: 12 month

  2. Monthly incidence of SARS-CoV-2 infection

    Time frame: Month 1 thru month 12

  3. Stratified incidence of SARS-CoV-2 infection by age group

    Time frame: Month 1 thru month 12

  4. Stratified incidence of SARS-CoV-2 infection by sex

    Time frame: Month 1 thru month 12

  5. Stratified incidence of SARS-CoV-2 by season

    Time frame: Month 1 thru month 12

  6. Stratified incidence of SARS-CoV-2 infection by geographic area (zip code)

    Time frame: Month 1 thru month 12

  7. Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities

    Time frame: Month 1 thru month 12

  8. Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts

    Time frame: Month 1 thru month 12

  9. Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers

    Time frame: Month 1 thru month 12

  10. Relative risk of SARS-CoV-2 infection by age group

    Time frame: Month 1 thru month 12

  11. Relative risk of SARS-CoV-2 infection by sex

    Time frame: Month 1 thru month 12

  12. Relative risk of SARS-CoV-2 infection by season

    Time frame: Month 1 thru month 12

  13. Relative risk of SARS-CoV-2 infection by geographic area (zip code)

    Time frame: Month 1 thru month 12

  14. Relative risk of SARS-CoV-2 infection by preexisting comorbidities

    Time frame: Month 1 thru month 12

  15. Relative risk of SARS-CoV-2 infection by COVID-2 contacts

    Time frame: Month 1 thru month 12

  16. Relative risk of SARS-CoV-2 infection by use of PPE by health workers

    Time frame: Month 1 thru month 12

  17. Incidence of sequelae

    Time frame: Month 1 thru month 12

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Centers for Disease Control and Prevention
  • North Carolina Department of Health and Human Services

Registry information

Official study title

A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2020
Registry last updated
Mar 30, 2023

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.

Published trials that share one or more normalized conditions with this study.