Coronavirus, COVID
Conditions
Keywords
COVID-19
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.
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.
Interventions
None listed
Sponsors
Centers for Disease Control and Prevention
North Carolina Department of Health and Human Services
Wake Forest University Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Cumulative incidence of SARS-CoV-2 infection | 12 month |
| 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 |
| Incidence of sequelae | Month 1 thru month 12 |
| Relative risk of SARS-CoV-2 infection by use of PPE by health workers | Month 1 thru month 12 |
| Monthly incidence of SARS-CoV-2 infection | Month 1 thru month 12 |
Countries
United States
Outcome results
None listed