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Clinical Trial Details — Status: Withdrawn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
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• Coronavirus Infections
• COVID-19
• Influenza
• Influenza, Human

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

External Links

•   To obtain contact information for a study center near you, click here.