COVID-19 Community Research Partnership

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342884
• Other study ID #: IRB00064912
• Secondary ID: FP00000129SC-75D
• Status: Completed
• Start date: April 8, 2020
• Est. completion date: May 2, 2022

Study information

• Verified date: May 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT04361123

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61410
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• COVID
• COVID-19

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Atrium Health	Charlotte	North Carolina
United States	Medstar Health	Columbia	Maryland
United States	Vidant Health	Greenville	North Carolina
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Campbell University School of Osteopathic Medicine	Lillington	North Carolina
United States	Tulane University School of Public Health and Tropical Medicine	New Orleans	Louisiana
United States	New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	WakeMed Health and Hospitals	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina	Percent of volunteers who are 2019-nCoV Ab test positive	baseline
Primary	Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina	Percent of volunteers who are 2019-nCoV Ab test positive	baseline
Secondary	Cumulative incidence of SARS-CoV-2 infection		12 month
Secondary	Monthly incidence of SARS-CoV-2 infection		Month 1 thru month 12
Secondary	Stratified incidence of SARS-CoV-2 infection by age group		Month 1 thru month 12
Secondary	Stratified incidence of SARS-CoV-2 infection by sex		Month 1 thru month 12
Secondary	Stratified incidence of SARS-CoV-2 by season		Month 1 thru month 12
Secondary	Stratified incidence of SARS-CoV-2 infection by geographic area (zip code)		Month 1 thru month 12
Secondary	Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities		Month 1 thru month 12
Secondary	Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts		Month 1 thru month 12
Secondary	Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers		Month 1 thru month 12
Secondary	Relative risk of SARS-CoV-2 infection by age group		Month 1 thru month 12
Secondary	Relative risk of SARS-CoV-2 infection by sex		Month 1 thru month 12
Secondary	Relative risk of SARS-CoV-2 infection by season		Month 1 thru month 12
Secondary	Relative risk of SARS-CoV-2 infection by geographic area (zip code)		Month 1 thru month 12
Secondary	Relative risk of SARS-CoV-2 infection by preexisting comorbidities		Month 1 thru month 12
Secondary	Relative risk of SARS-CoV-2 infection by COVID-2 contacts		Month 1 thru month 12
Secondary	Relative risk of SARS-CoV-2 infection by use of PPE by health workers		Month 1 thru month 12
Secondary	Incidence of sequelae		Month 1 thru month 12