The main purpose of this study is to understand: * the symptoms of COVID-19 or influenza- health-related outcomes of people with COVID-19 or influenza (influenza only included in updated study analyses) * the potential effects of COVID-19 vaccines in people with COVID-19 This study will enroll participants who are: * 18 years or older * reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS pharmacy COVID-19 or influenza test sites. The study will collect vaccine history information from participants who are ready to take part in the study. Participant will be emailed a form with questions about their health related to COVID-19 or influenza during multiple follow-ups over a 6-month period.
This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs including: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, and WPAI over 6 months will be collected and evaluated. COVID-19 Cohort: Participants 18 years or older with test-confirmed COVID-19 illness and at least one patient-reported symptom. Influenza Cohort: Participants 18 years or older with test-confirmed influenza illness and at least one patient-reported symptom. All study objectives and outcomes will be assessed separately for the two study cohorts. Influenza cohort is only included in updated study analyses.
Study Type
OBSERVATIONAL
Enrollment
999
Receipt of Pfizer BioNTech COVID-19 vaccine
Pfizer
New York, New York, United States
Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L
To assess the change in HRQoL using EQ-5D-5L before COVID-19 or influenza and over a 6-month period following the test-confirmed COVID-19 or influenza.
Time frame: 6 months
EQ-5D-5L Utility Index (UI) scores
To estimate the EQ-5D-5L UI scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.
Time frame: 6 months
Visual Analog Scale (VAS) scores
To estimate the VAS scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.
Time frame: 6 months
WPAI scores
To estimate the WPAI scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.
Time frame: 6 months
Prevalence and duration of SARS-CoV-2 symptoms
To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID).
Time frame: 6 months
Prevalence, Severity, and duration of influenza symptoms aggregated as index score area under the curve
To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu). Outcome will be aggregated by assigning a point-scale to the symptom severity and calculating the area under the curve of the severity index score.
Time frame: 6 Months
Fatigue before COVID-19
To assess fatigue (using PROMIS questionnaire Fatigue short-form 8a) before COVID-19 and over a six-month follow-up.
Time frame: 6 months
Fatigue after COVID-19
To estimate the PROMIS questionnaire Fatigue short-form 8a score and its change across six time points in a span of six months following the RT-PCR confirmed COVID-19.
Time frame: 6 months
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