NCT04342884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61,410

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

March 30, 2023

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

April 8, 2020

Last Update Submit

March 29, 2023

Conditions

CoronavirusCOVID

Keywords

COVID-19

Outcome Measures

Primary Outcomes (2)

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

    Percent of volunteers who are 2019-nCoV Ab test positive

    baseline

  • 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 Outcomes (17)

  • Cumulative incidence of SARS-CoV-2 infection

    12 month

  • Monthly incidence of SARS-CoV-2 infection

    Month 1 thru month 12

  • Stratified incidence of SARS-CoV-2 infection by age group

    Month 1 thru month 12

  • Stratified incidence of SARS-CoV-2 infection by sex

    Month 1 thru month 12

  • Stratified incidence of SARS-CoV-2 by season

    Month 1 thru month 12

  • +12 more secondary outcomes

Study Arms (2)

Clients of Wake Forest Baptist Health (WFBH)

Health care workers of Wake Forest Baptist Health (WFBH)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Tulane University School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Medstar Health

Columbia, Maryland, 21044, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Atrium Health

Charlotte, North Carolina, 28202, United States

Location

Vidant Health

Greenville, North Carolina, 27834, United States

Location

Campbell University School of Osteopathic Medicine

Lillington, North Carolina, 27546, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

WakeMed Health and Hospitals

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (6)

  • 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.

    PMID: 37649617DERIVED

  • 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.

    PMID: 37009915DERIVED

  • 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.

    PMID: 36606308DERIVED

  • 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.

    PMID: 36573634DERIVED

  • 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.

    PMID: 36117003DERIVED

  • 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.

    PMID: 34383157DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • John W Sanders, MD, MPH&TM

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 13, 2020

Study Start

April 8, 2020

Primary Completion

May 2, 2022

Study Completion

May 2, 2022

Last Updated

March 30, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(11)