Official Title
A 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 coronavirus exposures, symptoms, and health care visits due to the among Atrium Health clients and health care workers. 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 Atrium Health. 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.

Enrolling by invitation

Other: daily syndromic surveillance
Each volunteer will be securely linked to an Oracle developed, self-reporting online HIPAA-compliant data system through a secure app on their smartphone, tablet, or computer. Volunteers will report their illness symptoms daily, health seeking behavior and treatment, COVID-19 contacts, and, for health care workers, use of PPE.
Clients of Atrium Health
Health care workers of Atrium Health

Diagnostic Test: monthly serologic IgM/G test
At baseline to measure seroprevalence, and once every month after to detect seroconversions, we will use serological antibody tests for SARS-CoV-2 on a sample of volunteers demographically representative of populations served by Atrium Health.
Clients of Atrium Health
Health care workers of Atrium Health

Eligibility Criteria

Inclusion Criteria: - All clients and health care workers of Atrium Health are eligible for enrollment

Exclusion Criteria: - None

Eligibility Gender
Eligibility Age
Minimum: 18 Years
United States

Atrium Health
Charlotte, North Carolina, 28203

Michael Runyon, MD, MPH
Principal Investigator
Atrium Health

Michael Runyon, MD
NCT Number
MeSH Terms
Coronavirus Infections