COVID-19 Community Research Partnership

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronavirus, COVID

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clients of Wake Forest Baptist Health (WFBH)<br> | |
| Health care workers of Wake Forest Baptist Health (WFBH)<br> | |

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19