NCT05160636

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

Patient-Reported Outcomes Associated With COVID-19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Test-Confirmed Illness in the United States

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 999 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• COVID-19
• Coronavirus Disease 2019
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine	Receipt of Pfizer BioNTech COVID-19 vaccine

Timeline

• Start date: 2022-01-31
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2021-12-16
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study