NCT04342884

COVID-19 Community Research Partnership

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61,410 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Coronavirus
• COVID

Timeline

• Start date: 2020-04-08
• Primary completion: 2022-05-02
• Completion: 2022-05-02
• First posted: 2020-04-13
• Last updated: 2023-03-30

Locations

11 sites across 1 country: United States