Clinical trial NCT06163677: A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza.
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID-19
Coronavirus Disease 2019
Influenza
Keywords: Patient-Reported Outcomes
Humanistic Burden
Quality of Life
Disease Symptoms Assessment
COVID-19
SARS-CoV-2
Severe Acute Respiratory Syndrome Coronavirus 2 Infection
Acute respiratory infection
Influenza
Human Influenza
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants 18 years or older who are self-reported symptomatic, with laboratory-confirmed illness when tested at any of Walgreens pharmacy COVID-19 or influenza test sites, and consent to participate in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence, Severity, and duration of SARS-CoV-2 symptoms
timeFrame: 6 Months
measure: Prevalence, Severity, and duration of influenza symptoms
timeFrame: 6 Months
measure: Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L
timeFrame: 6 Months
measure: Change in Health Related Quality of Life (HRQoL) using WPAI:GH
timeFrame: 6 Months
measure: EQ-5D-5L Utility Index (UI) scores
timeFrame: 6 Months
measure: Visual Analog Scale (VAS) scores
timeFrame: 6 Months
measure: Work Productivity and Activity Impairment (WPAI) scores
timeFrame: 6 Months
Secondary outcomes:
measure: Fatigue after COVID-19 or influenza
timeFrame: 6 Months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: