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

February 29, 2024 updated by: Pfizer

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 Positive
Laboratory-confirmed COVID-19 illness and at least one patient-reported symptom
Biological: COVID-19 Vaccine
Receipt of Pfizer BioNTech COVID-19 vaccine
Influenza Positive
Laboratory-confirmed influenza illness and at least one patient-reported symptom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence, Severity, and duration of SARS-CoV-2 symptoms
Time Frame: 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).
6 Months
Prevalence, Severity, and duration of influenza symptoms
Time Frame: 6 Months
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
Time Frame: 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.
6 Months
Change in Health Related Quality of Life (HRQoL) using WPAI:GH
Time Frame: 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.
6 Months
EQ-5D-5L Utility Index (UI) scores
Time Frame: 6 Months
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
Time Frame: 6 Months
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
Time Frame: 6 Months
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
Time Frame: 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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2024

Primary Completion (Actual)

January 17, 2024

Study Completion (Actual)

January 17, 2024

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4591064

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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