A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
Purpose
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.
Conditions
- COVID-19
- Coronavirus Disease 2019
- Influenza
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 18 or older - Self-reported at least one symptom in the CVS Health pre-test screening questionnaire - Positive result reported from diagnostic test for COVID-19 (or influenza in updated analysis) - Evidence of a signed and dated informed consent through electronic consent process indicating that the participant has been informed of all pertinent aspects of the study - Able to complete the questionnaires by themselves in English or Spanish
Exclusion Criteria
- No symptoms reported in the study screening questionnaire
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| COVID-19 Positive | Test-confirmed COVID-19 illness and at least one patient-reported symptom |
|
| Influenza Positive | Test-confirmed influenza illness and at least one patient-reported symptom |
|
Recruiting Locations
Woonsocket, Rhode Island 02895
More Details
- NCT ID
- NCT05160636
- Status
- Recruiting
- Sponsor
- Pfizer
Detailed Description
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.