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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID-19, Coronavirus Disease 2019, Influenza

Intervention / Treatment
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* Biological: COVID-19 Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 Positive<br>Laboratory-confirmed COVID-19 illness and at least one patient-reported symptom | Biological: COVID-19 Vaccine<br>* Receipt of Pfizer BioNTech COVID-19 vaccine<br>|
| Influenza Positive<br>Laboratory-confirmed influenza illness and at least one patient-reported symptom | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Patient-Reported Outcomes, Humanistic Burden, Quality of Life, Disease Symptoms Assessment, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus 2 Infection, Acute respiratory infection, Influenza, Human Influenza