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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult volunteers living or employed in Lake County, Illinois.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Lakes Clinical Trials /ID# 224874 | Chicago | Illinois | 60640 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38461480 | Derived | 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. | |
| 35107821 |
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Whole blood sample
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 |
| 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. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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