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

Overview

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.

Full Title of Study: “EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 24, 2021

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Percentage of Participants With COVID-19 Hospitalization
    • Time Frame: 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
    • Time Frame: Up to approximately 9 months
    • Influenza and COVID-like illness is an indicator of potentially undiagnosed COVID-19 illness.
  • Time to Infection
    • Time Frame: Up to approximately 9 months
    • The analysis for overall time-to-infection will be conducted using the Kaplan-Meier method.
  • Time to Symptom Onset
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: Up to approximately 9.5 months
    • Change in quality of life is assessed through 5-level EQ-5D questionnaire (ED-5Q-5L)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AbbVie Inc., Study Director, AbbVie
  • Overall Contact(s)
    • ABBVIE CALL CENTER, 844-663-3742, abbvieclinicaltrials@abbvie.com

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