EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2)
- Sponsor
- AbbVie
- Enrollment
- 1007
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
- 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)
- Change in Quality of Life (QOL)(Up to approximately 9.5 months)
- Time to Symptom Resolution(Up to approximately 9 months)
- Time to Infection(Up to approximately 9 months)
- Time to Symptom Onset(Up to approximately 9 months)