COVID-19 Community Research Partnership

NCT ID: NCT04342884

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61410 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-08
• Study Completion Date: 2022-05-02

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Clients of Wake Forest Baptist Health (WFBH)

No interventions assigned to this group

Health care workers of Wake Forest Baptist Health (WFBH)

No interventions assigned to this group

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

North Carolina Department of Health and Human Services

OTHER_GOV

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John W Sanders, MD, MPH&TM

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Tulane University School of Public Health and Tropical Medicine

New Orleans, Louisiana, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

Medstar Health

Columbia, Maryland, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Atrium Health

Charlotte, North Carolina, United States

Vidant Health

Greenville, North Carolina, United States

Campbell University School of Osteopathic Medicine

Lillington, North Carolina, 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, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37649617 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37009915 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36606308 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36573634 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36117003 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34383157 (View on PubMed)

Other Identifiers

FP00000129

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SC-75D30120C08405

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00064912

Identifier Type: -

Identifier Source: org_study_id

NCT04361123

Identifier Type: -

Identifier Source: nct_alias