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CoronavirusNCT04342884

COVID-19 Community Research Partnership

An observational study of Coronavirus and COVID, run by Wake Forest University Health Sciences at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Coronavirus, COVID
How many people
61,410 participants
Where
11 sitesUnited States
Study dates
8 Apr 2020to 2 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Investigators will seek enrollment of the clients and health care workers from diverse hospitals and clinics of WFBH.

Who may be able to join

  • All clients and health care worker of WFBH are eligible for enrollment.

Who cannot join

  • Health care workers who do not receive medical services through WFBH will not be enrolled.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Atrium Health

    Charlotte, North Carolina, 28202

  • Medstar Health

    Columbia, Maryland, 21044

  • Vidant Health

    Greenville, North Carolina, 27834

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Campbell University School of Osteopathic Medicine

    Lillington, North Carolina, 27546

  • Tulane University School of Public Health and Tropical Medicine

    New Orleans, Louisiana, 70112

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • WakeMed Health and Hospitals

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records

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.

Read the 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.

Conditions
Coronavirus, COVID
Keywords
COVID-19
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04342884
Study groupRoleWhat they receive
Clients of Wake Forest Baptist Health (WFBH)Not described
Health care workers of Wake Forest Baptist Health (WFBH)Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Percent of volunteers who are 2019-nCoV Ab test positive

    Measured: baseline

  2. Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina

    Percent of volunteers who are 2019-nCoV Ab test positive

    Measured: baseline

Secondary outcomes (17)

  1. Cumulative incidence of SARS-CoV-2 infection

    Measured: 12 month

  2. Monthly incidence of SARS-CoV-2 infection

    Measured: Month 1 thru month 12

  3. Stratified incidence of SARS-CoV-2 infection by age group

    Measured: Month 1 thru month 12

  4. Stratified incidence of SARS-CoV-2 infection by sex

    Measured: Month 1 thru month 12

  5. Stratified incidence of SARS-CoV-2 by season

    Measured: Month 1 thru month 12

  6. Stratified incidence of SARS-CoV-2 infection by geographic area (zip code)

    Measured: Month 1 thru month 12

  7. Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities

    Measured: Month 1 thru month 12

  8. Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts

    Measured: Month 1 thru month 12

  9. Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers

    Measured: Month 1 thru month 12

  10. Relative risk of SARS-CoV-2 infection by age group

    Measured: Month 1 thru month 12

  11. Relative risk of SARS-CoV-2 infection by sex

    Measured: Month 1 thru month 12

  12. Relative risk of SARS-CoV-2 infection by season

    Measured: Month 1 thru month 12

  13. Relative risk of SARS-CoV-2 infection by geographic area (zip code)

    Measured: Month 1 thru month 12

  14. Relative risk of SARS-CoV-2 infection by preexisting comorbidities

    Measured: Month 1 thru month 12

  15. Relative risk of SARS-CoV-2 infection by COVID-2 contacts

    Measured: Month 1 thru month 12

  16. Relative risk of SARS-CoV-2 infection by use of PPE by health workers

    Measured: Month 1 thru month 12

  17. Incidence of sequelae

    Measured: Month 1 thru month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2020
  2. Study start8 Apr 2020
  3. Primary completion2 May 2022
  4. Study completion2 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
61,410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04342884
Sponsor's protocol ID
IRB00064912
Other IDs
FP00000129, SC-75D30120C08405
Status last verified
May 2022
First submitted
8 Apr 2020
Last updated
30 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Beron AJ, Yukich JO, Berry AA, Correa A, Keating J, Bott M, Wierzba TF, Weintraub WS, Friedman-Klabanoff DJ, Mongraw-Chaffin M, Gibbs MA, Taylor YJ, Kissinger PJ, Hayes DV, Schieffelin JS, Burke BK, Oberhelman RA. Assessment of sociodemographic factors associated with time to self-reported COVID-19 infection among a large multi-center prospective cohort population in the southeastern United States. PLoS One. 2024 Sep 6;19(9):e0293787. doi: 10.1371/journal.pone.0293787. eCollection 2024.

    PubMed 39240796

  • Berry AA, Tjaden AH, Renteria J, Friedman-Klabanoff D, Hinkelman AN, Gibbs MA, Ahmed A, Runyon MS, Schieffelin J, Santos RP, Oberhelman R, Bott M, Correa A, Edelstein SL, Uschner D, Wierzba TF; COVID-19 Community Research Partnership. Persistence of antibody responses to COVID-19 vaccines among participants in the COVID-19 Community Research Partnership. Vaccine X. 2023 Aug 11;15:100371. doi: 10.1016/j.jvacx.2023.100371. eCollection 2023 Dec.

    PubMed 37649617

  • Ahmed A, DeWitt ME, Dantuluri KL, Castri P, Buahin A, LaGarde WH, Weintraub WS, Rossman W, Santos RP, Gibbs M, Uschner D; COVID-19 Community Research Partnership. Characterisation of infection-induced SARS-CoV-2 seroprevalence amongst children and adolescents in North Carolina. Epidemiol Infect. 2023 Apr 3;151:e63. doi: 10.1017/S0950268823000481.

    PubMed 37009915

  • Tjaden AH, Edelstein SL, Ahmed N, Calamari L, Dantuluri KL, Gibbs M, Hinkelman A, Mongraw-Chaffin M, Sanders JW, Saydah S, Plumb ID; COVID-19 Community Research Partnership Study Group. Association between COVID-19 and consistent mask wearing during contact with others outside the household-A nested case-control analysis, November 2020-October 2021. Influenza Other Respir Viruses. 2023 Jan;17(1):e13080. doi: 10.1111/irv.13080. Epub 2023 Jan 5.

    PubMed 36606308

  • DeWitt ME, Tjaden AH, Herrington D, Schieffelin J, Gibbs M, Weintraub WS, Sanders JW, Edelstein SL; COVID-19 Community Research Partnership. COVID-19 Symptoms by Variant Period in the North Carolina COVID-19 Community Research Partnership, North Carolina, USA. Emerg Infect Dis. 2023 Jan;29(1):207-211. doi: 10.3201/eid2901.221111.

    PubMed 36573634

  • Friedman-Klabanoff DJ, Tjaden AH, Santacatterina M, Munawar I, Sanders JW, Herrington DM, Wierzba TF, Berry AA; COVID-19 Community Research Partnership. Vaccine-induced seroconversion in participants in the North Carolina COVID-19 community Research Partnership. Vaccine. 2022 Oct 6;40(42):6133-6140. doi: 10.1016/j.vaccine.2022.09.021. Epub 2022 Sep 12.

    PubMed 36117003

  • Peacock JE Jr, Herrington DM, Edelstein SL, Seals AL, Plumb ID, Saydah S, Lagarde WH, Runyon MS, Maguire PD, Correa A, Weintraub WS, Wierzba TF, Sanders JW; COVID-19 Community Research Partnership Study Group. Survey of Adherence with COVID-19 Prevention Behaviors During the 2020 Thanksgiving and Winter Holidays Among Members of the COVID-19 Community Research Partnership. J Community Health. 2022 Feb;47(1):71-78. doi: 10.1007/s10900-021-01021-z. Epub 2021 Aug 12.

    PubMed 34383157

Questions about this trial

What is this clinical trial studying?

An observational study of Coronavirus and COVID, run by Wake Forest University Health Sciences at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04342884, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.

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