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

Pfizer

Status: Withdrawn

Conditions: COVID-19; Influenza; Coronavirus Disease 2019

Treatments: Biological: COVID-19 Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT06163677

C4591064

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
• 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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Self-reported at least one symptom in the screening questionnaire
• Positive result reported from the laboratory
• Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
• Able to complete the questionnaires by themselves in English

Exclusion criteria

• Positive result for both COVID-19 and influenza (coinfection)
• COVID-19 test is done with non-RT-PCR methods such as a rapid antigen test or antibody test

Trial design

0 participants in 2 patient groups

COVID-19 Positive

Description:

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

Treatment:

Biological: COVID-19 Vaccine

Influenza Positive

Description:

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