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NCT06163677 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT06163677
Other study ID # C4591064
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 17, 2024
Est. completion date January 17, 2024

Study information
Verified date February 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 17, 2024
Est. primary completion date January 17, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• COVID-19 Vaccine
Receipt of Pfizer BioNTech COVID-19 vaccine

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
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