COVID-19 Community Research Partnership

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04342884
Collaborator
Centers for Disease Control and Prevention (U.S. Fed), North Carolina Department of Health and Human Services (Other)
150,000
11
34.7
13636.4
392.7

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

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    150000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records
    Actual Study Start Date :
    Apr 8, 2020
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Clients of Wake Forest Baptist Health (WFBH)

    Health care workers of Wake Forest Baptist Health (WFBH)

    Outcome Measures

    Primary Outcome Measures

    1. Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina [baseline]

      Percent of volunteers who are 2019-nCoV Ab test positive

    2. 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

    1. Cumulative incidence of SARS-CoV-2 infection [12 month]

    2. Monthly incidence of SARS-CoV-2 infection [Month 1 thru month 12]

    3. Stratified incidence of SARS-CoV-2 infection by age group [Month 1 thru month 12]

    4. Stratified incidence of SARS-CoV-2 infection by sex [Month 1 thru month 12]

    5. Stratified incidence of SARS-CoV-2 by season [Month 1 thru month 12]

    6. Stratified incidence of SARS-CoV-2 infection by geographic area (zip code) [Month 1 thru month 12]

    7. Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities [Month 1 thru month 12]

    8. Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts [Month 1 thru month 12]

    9. Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers [Month 1 thru month 12]

    10. Relative risk of SARS-CoV-2 infection by age group [Month 1 thru month 12]

    11. Relative risk of SARS-CoV-2 infection by sex [Month 1 thru month 12]

    12. Relative risk of SARS-CoV-2 infection by season [Month 1 thru month 12]

    13. Relative risk of SARS-CoV-2 infection by geographic area (zip code) [Month 1 thru month 12]

    14. Relative risk of SARS-CoV-2 infection by preexisting comorbidities [Month 1 thru month 12]

    15. Relative risk of SARS-CoV-2 infection by COVID-2 contacts [Month 1 thru month 12]

    16. Relative risk of SARS-CoV-2 infection by use of PPE by health workers [Month 1 thru month 12]

    17. Incidence of sequelae [Month 1 thru month 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT04342884
    Other Study ID Numbers:
    • IRB00064912
    • FP00000129
    • SC-75D30120C08405
    • NCT04361123
    First Posted:
    Apr 13, 2020
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wake Forest University Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 27, 2022