COVID-19 Community Research Partnership
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Arms and Interventions
Arm | Intervention/Treatment |
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Clients of Wake Forest Baptist Health (WFBH)
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Health care workers of Wake Forest Baptist Health (WFBH)
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Outcome Measures
Primary Outcome Measures
- Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina [baseline]
Percent of volunteers who are 2019-nCoV Ab test positive
- Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina [baseline]
Percent of volunteers who are 2019-nCoV Ab test positive
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tulane University School of Public Health and Tropical Medicine | New Orleans | Louisiana | United States | 70112 |
2 | University of Maryland School of Medicine | Baltimore | Maryland | United States | 21201 |
3 | Medstar Health | Columbia | Maryland | United States | 21044 |
4 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
5 | Atrium Health | Charlotte | North Carolina | United States | 28202 |
6 | Vidant Health | Greenville | North Carolina | United States | 27834 |
7 | Campbell University School of Osteopathic Medicine | Lillington | North Carolina | United States | 27546 |
8 | New Hanover Regional Medical Center | Wilmington | North Carolina | United States | 28401 |
9 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
10 | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157 |
11 | WakeMed Health and Hospitals | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- Centers for Disease Control and Prevention
- North Carolina Department of Health and Human Services
Investigators
- Principal Investigator: John W Sanders, MD, MPH&TM, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00064912
- FP00000129
- SC-75D30120C08405
- NCT04361123