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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)

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ClinicalTrials.gov Identifier: NCT04611230
Recruitment Status : Completed
First Posted : November 2, 2020
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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
Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)

Study Design
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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 : November 5, 2020
Actual Primary Completion Date : October 27, 2021
Actual Study Completion Date : October 27, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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)


Biospecimen Retention:   Samples With DNA
Whole blood sample

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult volunteers living or employed in Lake County, Illinois.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611230


Locations
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United States, Illinois
Great Lakes Clinical Trials /ID# 224874
Chicago, Illinois, United States, 60640
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT04611230    
Other Study ID Numbers: H20-308
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by AbbVie:
Severe acute respiratory syndrome - coronavirus 2
SARS-CoV-2
Coronavirus disease 2019
COVID-19
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome
Syndrome
Disease
Pathologic Processes
Respiratory Tract Infections
Infections
 Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases