Trials / Withdrawn
WithdrawnNCT06163677
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 Laboratory-Confirmed Illness in the United States
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- 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 * the effects of vaccines in people with COVID-19 or influenza. This study will take in participants who are: * 18 years or older * reported to have symptoms with lab tests that have confirmed illness. The lab tests can be tested at any of Walgreens 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 twelve follow-ups over a 6-month period.
Detailed description
This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, WPAI and PROMIS-Fatigue short form 8a over 6 months will be collected and evaluated. COVID-19 Cohort: Participants 18 years or older with laboratory-confirmed COVID-19 illness and at least one patient-reported symptom. Influenza Cohort: Participants 18 years or older with laboratory-confirmed influenza illness and at least one patient-reported symptom. All study objectives and outcomes will be assessed separately for the two study cohorts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | COVID-19 Vaccine | Receipt of Pfizer BioNTech COVID-19 vaccine |
Timeline
- Start date
- 2024-01-17
- Primary completion
- 2024-01-17
- Completion
- 2024-01-17
- First posted
- 2023-12-11
- Last updated
- 2024-03-01
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06163677. Inclusion in this directory is not an endorsement.