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

NCT ID: NCT04611230

Last Updated: 2022-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1007 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-05

Study Completion Date

2021-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Great Lakes Clinical Trials /ID# 224874

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Sanchez-Solino O, Kilpatrick RD, Johnson C, Fang Y, Ye Y, Alami NN, Zarish K, Krueger WS, Dreyer N, Gray GC. Longitudinal Molecular and Serological Evidence of SARS-CoV-2 Infections and Vaccination Status: Community-Based Surveillance Study (CONTACT). Infect Dis Ther. 2024 Apr;13(4):633-645. doi: 10.1007/s40121-024-00923-4. Epub 2024 Mar 10.

Reference Type DERIVED
PMID: 38461480 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35107821 (View on PubMed)

Related Links

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Other Identifiers

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H20-308

Identifier Type: -

Identifier Source: org_study_id

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