COVID-19 Community Research Partnership

Completed

• Conditions: Coronavirus; COVID

• Registration Number: NCT04342884
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2020-04-08
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Status Verified: 2022-05
• Primary Completion: 2022-05-02
• Study Completion: 2022-05-02
• Last Update Submitted: 2023-03-29
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61410

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina	baseline	Percent of volunteers who are 2019-nCoV Ab test positive
Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina	baseline	Percent of volunteers who are 2019-nCoV Ab test positive

Secondary Outcome Measures

Name	Time	Method
Stratified incidence of SARS-CoV-2 infection by sex	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by season	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by use of PPE by health workers	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by preexisting comorbidities	Month 1 thru month 12
Monthly incidence of SARS-CoV-2 infection	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by geographic area (zip code)	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by sex	Month 1 thru month 12
Cumulative incidence of SARS-CoV-2 infection	12 month
Stratified incidence of SARS-CoV-2 by season	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by age group	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by COVID-2 contacts	Month 1 thru month 12
Incidence of sequelae	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by age group	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by geographic area (zip code)	Month 1 thru month 12

Trial Locations

Locations (11)

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

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

Medstar Health; 🇺🇸 Columbia, Maryland, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Vidant Health; 🇺🇸 Greenville, North Carolina, United States

Campbell University School of Osteopathic Medicine; 🇺🇸 Lillington, North Carolina, United States

New Hanover Regional Medical Center; 🇺🇸 Wilmington, North Carolina, United States

WakeMed Health and Hospitals; 🇺🇸 Winston-Salem, North Carolina, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States