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COVID-19 Community Research Partnership

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342884
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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
Coronavirus COVID

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.

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Study Type : Observational
Estimated 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 : April 8, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Clients of Wake Forest Baptist Health (WFBH)
Health care workers of Wake Forest Baptist Health (WFBH)



Primary Outcome Measures :
  1. Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina [ Time Frame: 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 [ Time Frame: baseline ]
    Percent of volunteers who are 2019-nCoV Ab test positive


Secondary Outcome Measures :
  1. Cumulative incidence of SARS-CoV-2 infection [ Time Frame: 12 month ]
  2. Monthly incidence of SARS-CoV-2 infection [ Time Frame: Month 1 thru month 12 ]
  3. Stratified incidence of SARS-CoV-2 infection by age group [ Time Frame: Month 1 thru month 12 ]
  4. Stratified incidence of SARS-CoV-2 infection by sex [ Time Frame: Month 1 thru month 12 ]
  5. Stratified incidence of SARS-CoV-2 by season [ Time Frame: Month 1 thru month 12 ]
  6. Stratified incidence of SARS-CoV-2 infection by geographic area (zip code) [ Time Frame: Month 1 thru month 12 ]
  7. Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities [ Time Frame: Month 1 thru month 12 ]
  8. Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts [ Time Frame: Month 1 thru month 12 ]
  9. Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers [ Time Frame: Month 1 thru month 12 ]
  10. Relative risk of SARS-CoV-2 infection by age group [ Time Frame: Month 1 thru month 12 ]
  11. Relative risk of SARS-CoV-2 infection by sex [ Time Frame: Month 1 thru month 12 ]
  12. Relative risk of SARS-CoV-2 infection by season [ Time Frame: Month 1 thru month 12 ]
  13. Relative risk of SARS-CoV-2 infection by geographic area (zip code) [ Time Frame: Month 1 thru month 12 ]
  14. Relative risk of SARS-CoV-2 infection by preexisting comorbidities [ Time Frame: Month 1 thru month 12 ]
  15. Relative risk of SARS-CoV-2 infection by COVID-2 contacts [ Time Frame: Month 1 thru month 12 ]
  16. Relative risk of SARS-CoV-2 infection by use of PPE by health workers [ Time Frame: Month 1 thru month 12 ]
  17. Incidence of sequelae [ Time Frame: Month 1 thru month 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Investigators will seek enrollment of the clients and health care workers from diverse hospitals and clinics of WFBH.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342884


Contacts
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Contact: Wake Forest Baptist Medical Center 336-70-COVID jwsander@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: John W Sanders, MD, MPH&TM Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04342884    
Other Study ID Numbers: IRB00064912
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
COVID-19
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases