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Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06163677

Enrollment

Registered

2023-12-11

Start date

2024-01-17

Completion date

2024-01-17

Last updated

2024-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Disease 2019, COVID-19, 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

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.

Interventions

BIOLOGICALCOVID-19 Vaccine

Receipt of Pfizer BioNTech COVID-19 vaccine

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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).
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.
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.
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.

Secondary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026