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 (CONTACT)

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

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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)

• Study Type: Observational
• Enrollment (Actual): 1007

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials /ID# 224874

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult volunteers living or employed in Lake County, Illinois.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Kilpatrick RD, Sanchez-Solino O, Alami NN, Johnson C, Fang Y, Wegrzyn LR, Krueger WS, Ye Y, Dreyer N, Gray GC. EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois (CONTACT): Methodology and Baseline Characteristics of a Community-Based Surveillance Study. Infect Dis Ther. 2022 Apr;11(2):899-911. doi: 10.1007/s40121-022-00593-0. Epub 2022 Feb 2.

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): October 27, 2021
• Study Completion (Actual): October 27, 2021

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Coronavirus disease 2019; Severe acute respiratory syndrome - coronavirus 2
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease; Severe Acute Respiratory Syndrome; Coronavirus Infections; Syndrome
• Other Study ID Numbers: H20-308

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No