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.
Study Type
OBSERVATIONAL
Enrollment
1,007
Great Lakes Clinical Trials /ID# 224874
Chicago, Illinois, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Approximately 9 months
Percentage of Participants With COVID-19 Hospitalization
Percentage of participants with COVID-19 hospitalization prior to enrollment will be recorded.
Time frame: Up to approximately 9 months
Percentage of Participants With Influenza and COVID-like Illness
Influenza and COVID-like illness is an indicator of potentially undiagnosed COVID-19 illness.
Time frame: Up to approximately 9 months
Time to Infection
The analysis for overall time-to-infection will be conducted using the Kaplan-Meier method.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Up to approximately 9.5 months
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