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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04342884
Other study ID # IRB00064912
Secondary ID FP00000129SC-75D
Status Completed
Phase
First received
Last updated
Start date April 8, 2020
Est. completion date May 2, 2022

Study information

Verified date May 2022
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT04361123

Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Wake Forest University Health Sciences Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

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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