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

NCT04611230 | Completed

• 1 other identifier: H20-308
• Study Type: observational
• Target: 1,007
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Severe acute respiratory syndrome - coronavirus 2; SARS-CoV-2; Coronavirus disease 2019; COVID-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Percentage of Participants With COVID-19 Hospitalization

  Up to approximately 9 months

• Percentage of Participants With Influenza and COVID-like Illness

  Up to approximately 9 months

• Time to Infection

  Up to approximately 9 months

• Time to Symptom Onset

  Up to approximately 9 months

• Time to Symptom Resolution

  Up to approximately 9 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult volunteers living or employed in Lake County, Illinois.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Great Lakes Clinical Trials /ID# 224874

Chicago, Illinois, 60640, United States

Location

Related Publications (2)

• 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.

  PMID: 38461480 DERIVED

• 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.

  PMID: 35107821 DERIVED

Related Links

• clinical study report synopsis

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 2, 2020
• Study Start: November 5, 2020
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

US (1)