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

Eligibility Criteria

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

Eligibility Gender
Eligibility Age
Minimum: N/A ~ Maximum: N/A
United States

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

University of Maryland School of Medicine
Baltimore, Maryland, United States

Medstar Health
Columbia, Maryland, United States

University of Mississippi Medical Center
Jackson, Mississippi, 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

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, United States

John W Sanders, MD, MPH&TM, Principal Investigator
Wake Forest University Health Sciences

Wake Forest University Health Sciences
NCT Number
MeSH Terms