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

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.

Study Overview

• Status: Completed
• Conditions: COVID; Coronavirus

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.

• Study Type: Observational
• Enrollment (Actual): 61410

Contacts and Locations

• Study Contact: Name: Wake Forest Baptist Medical Center; Phone Number: 336-70-COVID; Email: jwsander@wakehealth.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University School of Public Health and Tropical Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
    • Columbia, Maryland, United States, 21044
      • MedStar Health
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28202
      • Atrium Health
    • Greenville, North Carolina, United States, 27834
      • Vidant Health
    • Lillington, North Carolina, United States, 27546
      • Campbell University School of Osteopathic Medicine
    • Wilmington, North Carolina, United States, 28401
      • New Hanover Regional Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Health
    • Winston-Salem, North Carolina, United States, 27157
      • WakeMed Health and Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Investigators will seek enrollment of the clients and health care workers from diverse hospitals and clinics of WFBH.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Clients of Wake Forest Baptist Health (WFBH)
Health care workers of Wake Forest Baptist Health (WFBH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina	Percent of volunteers who are 2019-nCoV Ab test positive	baseline
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 Outcome Measures

Outcome Measure	Time Frame
Cumulative incidence of SARS-CoV-2 infection	12 month
Monthly incidence of SARS-CoV-2 infection	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by age group	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by sex	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 by season	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by geographic area (zip code)	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts	Month 1 thru month 12
Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by age group	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by sex	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by season	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by geographic area (zip code)	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by preexisting comorbidities	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by COVID-2 contacts	Month 1 thru month 12
Relative risk of SARS-CoV-2 infection by use of PPE by health workers	Month 1 thru month 12
Incidence of sequelae	Month 1 thru month 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Centers for Disease Control and Prevention; North Carolina Department of Health and Human Services

Publications and helpful links

General Publications

• Friedman-Klabanoff DJ, Tjaden AH, Santacatterina M, Munawar I, Sanders JW, Herrington DM, Wierzba TF, Berry AA; COVID-19 Community Research Partnership. Vaccine-induced seroconversion in participants in the North Carolina COVID-19 community Research Partnership. Vaccine. 2022 Oct 6;40(42):6133-6140. doi: 10.1016/j.vaccine.2022.09.021. Epub 2022 Sep 12.
• Peacock JE Jr, Herrington DM, Edelstein SL, Seals AL, Plumb ID, Saydah S, Lagarde WH, Runyon MS, Maguire PD, Correa A, Weintraub WS, Wierzba TF, Sanders JW; COVID-19 Community Research Partnership Study Group. Survey of Adherence with COVID-19 Prevention Behaviors During the 2020 Thanksgiving and Winter Holidays Among Members of the COVID-19 Community Research Partnership. J Community Health. 2022 Feb;47(1):71-78. doi: 10.1007/s10900-021-01021-z. Epub 2021 Aug 12.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2020
• Primary Completion (Actual): May 2, 2022
• Study Completion (Actual): May 2, 2022

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IRB00064912; FP00000129 (Other Grant/Funding Number: North Carolina Department of Health and Human Services); SC-75D30120C08405 (Other Identifier: Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No