Atrium COVID-19 Syndromic and Serologic Surveillance

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04361123
• Other study ID #: 04-20-11A
• Status: Enrolling by invitation
• Start date: May 6, 2020
• Est. completion date: December 2021

Study information

• Verified date: July 2020
• Source: Atrium Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 450000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All clients and health care workers of Atrium Health are eligible for enrollment

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Michael Runyon, MD

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