COVID-19 Community Research Partnership

Wake Forest University (WFU)

Status: Completed

Conditions: COVID; Coronavirus

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04342884

FP00000129 (Other Grant/Funding Number)

SC-75D30120C08405 (Other Identifier)

IRB00064912

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61,410 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

61,410 participants in 2 patient groups

Clients of Wake Forest Baptist Health (WFBH)

Health care workers of Wake Forest Baptist Health (WFBH)