COVID Clinical Trial
Official title:
A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records
Verified date | May 2022 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 61410 |
Est. completion date | May 2, 2022 |
Est. primary completion date | May 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland School of Medicine | Baltimore | Maryland |
United States | Atrium Health | Charlotte | North Carolina |
United States | Medstar Health | Columbia | Maryland |
United States | Vidant Health | Greenville | North Carolina |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Campbell University School of Osteopathic Medicine | Lillington | North Carolina |
United States | Tulane University School of Public Health and Tropical Medicine | New Orleans | Louisiana |
United States | New Hanover Regional Medical Center | Wilmington | North Carolina |
United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
United States | WakeMed Health and Hospitals | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services |
United States,
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 |
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