A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza

Pfizer

Status: Active, not recruiting

Conditions: COVID-19; Influenza; Coronavirus Disease 2019

Treatments: Biological: COVID-19 Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT05160636

NCT05160636 (Registry Identifier)

C4591034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 999 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

999 participants in 2 patient groups

COVID-19 Positive

Description:

Test-confirmed COVID-19 illness and at least one patient-reported symptom

Treatment:

Biological: COVID-19 Vaccine

Influenza Positive

Description:

Test-confirmed influenza illness and at least one patient-reported symptom