Clinical trial NCT04342884: COVID-19 Community Research Partnership
Official title: A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
COVID
Keywords: COVID-19
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: North Carolina Department of Health and Human Services
First posted: 2020-04-13
Enrollment: 61410
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina
timeFrame: baseline
measure: Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina
timeFrame: baseline
Secondary outcomes:
measure: Cumulative incidence of SARS-CoV-2 infection
timeFrame: 12 month
measure: Monthly incidence of SARS-CoV-2 infection
timeFrame: Month 1 thru month 12
measure: Stratified incidence of SARS-CoV-2 infection by age group
timeFrame: Month 1 thru month 12
measure: Stratified incidence of SARS-CoV-2 infection by sex
timeFrame: Month 1 thru month 12
measure: Stratified incidence of SARS-CoV-2 by season
timeFrame: Month 1 thru month 12
measure: Stratified incidence of SARS-CoV-2 infection by geographic area (zip code)
timeFrame: Month 1 thru month 12
measure: Stratified incidence of SARS-CoV-2 infection by preexisting comorbidities
timeFrame: Month 1 thru month 12
measure: Stratified incidence of SARS-CoV-2 infection by COVID-2 contacts
timeFrame: Month 1 thru month 12
measure: Stratified incidence of SARS-CoV-2 infection by use of personal protective equipment (PPE) by health workers
timeFrame: Month 1 thru month 12
measure: Relative risk of SARS-CoV-2 infection by age group
timeFrame: Month 1 thru month 12
measure: Relative risk of SARS-CoV-2 infection by sex
timeFrame: Month 1 thru month 12
measure: Relative risk of SARS-CoV-2 infection by season
timeFrame: Month 1 thru month 12
measure: Relative risk of SARS-CoV-2 infection by geographic area (zip code)
timeFrame: Month 1 thru month 12
measure: Relative risk of SARS-CoV-2 infection by preexisting comorbidities
timeFrame: Month 1 thru month 12
measure: Relative risk of SARS-CoV-2 infection by COVID-2 contacts
timeFrame: Month 1 thru month 12
measure: Relative risk of SARS-CoV-2 infection by use of PPE by health workers
timeFrame: Month 1 thru month 12
measure: Incidence of sequelae
timeFrame: Month 1 thru month 12
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University School of Public Health and Tropical Medicine
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Columbia
country: United States
facility: Medstar Health
state: Maryland
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Greenville
country: United States
facility: Vidant Health
state: North Carolina
city: Lillington
country: United States
facility: Campbell University School of Osteopathic Medicine
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: WakeMed Health and Hospitals
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: John W Sanders, MD, MPH&TM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.