CONTACT: A Study to Assess Infection Rate of Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2) and It's Affect on Quality of Life in Adult Volunteers in Lake County, Illinois

Sponsor

AbbVie (Industry)

Overall Status

Completed

CT.gov ID

NCT04611230

Collaborator

(none)

1,007

Enrollment

Location

11.7

Actual Duration (Months)

86.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to assess infection of SARS-CoV-2 and how quality of life is affected in adult volunteers in Lake County, Illinois.

Volunteers will be recruited through digital advertisements and participants will be required to fill an online questionnaire. Upon consent, participants will be required to provide nasal swab and blood sample. Approximately 1250 adult volunteers living or working in Lake County, IL will be enrolled.

Participants will be followed for approximately 9 months and will be required to provide nasal swab and blood samples every 3 months and complete questionnaires every 2 weeks.

There may be higher treatment burden for participants in this trial. Participants will be monitored by medical assessments, blood tests and questionnaires.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)

Study Design

Study Type:

Observational

Actual Enrollment :

1007 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT

Actual Study Start Date :

Nov 5, 2020

Actual Primary Completion Date :

Oct 27, 2021

Actual Study Completion Date :

Oct 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Adult Volunteers (Low Risk Group) Volunteers with jobs that do not require close contact with (i.e., within 6 feet of) the general public or co-workers.
Adult Volunteers (Medium - Low Risk Group) Volunteers with jobs that require in-frequent contact with (i.e., within 6 feet of) the general public or co-workers.
Adult Volunteers (Medium - High Risk Group) Volunteers with jobs that require frequent contact with (i.e., within 6 feet of) the general public or co-workers.
Adult Volunteers (High Risk Group) Volunteers with jobs that require frequent and/or close contact with (i.e., within 6 feet of) individuals with high potential for exposure to known or suspected sources of COVID-19.

Outcome Measures

Primary Outcome Measures

Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection [Baseline (Week 0)]
SARS-CoV-2 infection prior to enrollment is assessed by Immunoglobulin G (IgG) serology testing and/or self-reported diagnosis.
Percentage of Participants With Current SARS-CoV-2 Infection [Baseline (Week 0)]
SARS-CoV-2 active infection is assessed by polymerase chain reaction (PCR) testing.
Percentage of Participants With Incidence of SARS-CoV-2 Infection [Up to Approximately 9 months]
Incidence of SARS-CoV-2 Infection is assessed by positive PCR test, positive IgG serology test or COVID-19 diagnosis.

Secondary Outcome Measures

Percentage of Participants With COVID-19 Hospitalization [Up to approximately 9 months]
Percentage of participants with COVID-19 hospitalization prior to enrollment will be recorded.
Percentage of Participants With Influenza and COVID-like Illness [Up to approximately 9 months]
Influenza and COVID-like illness is an indicator of potentially undiagnosed COVID-19 illness.
Time to Infection [Up to approximately 9 months]
The analysis for overall time-to-infection will be conducted using the Kaplan-Meier method.
Time to Symptom Onset [Up to approximately 9 months]
The analysis for overall time to symptom onset will be conducted using the Kaplan-Meier method.
Time to Symptom Resolution [Up to approximately 9 months]
The analysis for overall time to symptom resolution will be conducted using the Kaplan-Meier method.
Change in Quality of Life (QOL) [Up to approximately 9.5 months]
Change in quality of life is assessed through 5-level EQ-5D questionnaire (ED-5Q-5L)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Currently living or employed in Lake County, Illinois.
Have regular access to computer, smartphone or tablet and sufficient internet access to connect to study platform.
Willing and able to provide informed consent for collection of online data and of respiratory and blood specimens.
Willing and able to follow the procedures of the study.
Able to complete survey in English or Spanish.

Exclusion Criteria:

Unable to provide informed consent.
Unable to perform the requested study tasks and unable or unwilling to assign a proxy informant to complete the tasks.
Hospitalized at the time of study enrollment.