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

Withdrawn

• Conditions: COVID-19; Coronavirus Disease 2019; Influenza
• Interventions: Biological: COVID-19 Vaccine

• Registration Number: NCT06163677
• Lead Sponsor: Pfizer

Brief 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.

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-11
• Study Start: 2024-01-17
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 Positive	COVID-19 Vaccine	Laboratory-confirmed COVID-19 illness and at least one patient-reported symptom

Primary Outcome Measures

Name	Time	Method
Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L	6 Months	To assess the change in HRQoL using EQ-5D-5L before COVID-19 or influenza and over a 6-month period following lab confirmed COVID-19 or influenza.
Prevalence, Severity, and duration of influenza symptoms	6 Months	To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu).
Prevalence, Severity, and duration of SARS-CoV-2 symptoms	6 Months	To characterize prevalence and duration of SARS-CoV-2 symptoms before COVID-19 and up to 6 months (acute phase and Long COVID).
Visual Analog Scale (VAS) scores	6 Months	To estimate the VAS scores and their change over six months following the lab confirmed COVID-19 or influenza.
Change in Health Related Quality of Life (HRQoL) using WPAI:GH	6 Months	To assess the change in HRQoL using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH) before COVID-19 or influenza and over a 6-month period following lab confirmed COVID-19 or influenza.
EQ-5D-5L Utility Index (UI) scores	6 Months	To estimate the EQ-5D-5L UI scores and their change over six months following lab confirmed COVID-19 or influenza.
Work Productivity and Activity Impairment (WPAI) scores	6 Months	To estimate the WPAI scores and their change over six months following the lab confirmed COVID-19 or influenza.

Secondary Outcome Measures

Name	Time	Method
Fatigue after COVID-19 or influenza	6 Months	To estimate the PROMIS questionnaire Fatigue short-form 8a score and its change over six months following lab confirmed COVID-19 or influenza.