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

NCT06163677 | Withdrawn FDA Drug

• 1 other identifier: C4591064
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; Coronavirus Disease 2019; 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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Fatigue after COVID-19 or influenza

  6 Months

Study Arms (2)

COVID-19 Positive

Laboratory-confirmed COVID-19 illness and at least one patient-reported symptom

Biological: COVID-19 Vaccine

Influenza Positive

Laboratory-confirmed influenza illness and at least one patient-reported symptom

Interventions

COVID-19 Vaccine BIOLOGICAL

Receipt of Pfizer BioNTech COVID-19 vaccine

COVID-19 Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

COVID-19; Influenza, Human

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 11, 2023
• Study Start: January 17, 2024
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share