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Active, Not Recruiting

NCT Number: NCT05160636

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

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 (influenza only included in updated study analyses) * the potential effects of COVID-19 vaccines in people with COVID-19

This study will enroll participants who are:

* 18 years or older * reported to have symptoms with tests that have confirmed illness. The tests can be taken at any of CVS 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 multiple follow-ups over a 6-month period.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Disease 2019 Coronavirus Infections Infections Influenza Influenza, Human Lung Diseases Nidovirales Infections Orthomyxoviridae Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10001, United States

About this study

This is a prospective non-interventional longitudinal cohort survey study. Repeated measures on PROs including: symptoms (prevalence, frequency, duration, and severity), EQ-5D-5L, and WPAI over 6 months will be collected and evaluated.

COVID-19 Cohort: Participants 18 years or older with test-confirmed COVID-19 illness and at least one patient-reported symptom.

Influenza Cohort: Participants 18 years or older with test-confirmed influenza illness and at least one patient-reported symptom.

All study objectives and outcomes will be assessed separately for the two study cohorts. Influenza cohort is only included in updated study analyses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Self-reported at least one symptom in the CVS Health pre-test screening questionnaire
  • Positive result reported from diagnostic test for COVID-19 (or influenza in updated analysis)
  • Evidence of a signed and dated informed consent through electronic consent process indicating that the participant has been informed of all pertinent aspects of the study
  • Able to complete the questionnaires by themselves in English or Spanish

Exclusion criteria

  • No symptoms reported in the study screening questionnaire

Treatment and study plan

COVID-19 vaccine

Biological

Receipt of Pfizer BioNTech COVID-19 vaccine

Primary outcomes

  1. 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 the test-confirmed COVID-19 or influenza.

  2. EQ-5D-5L Utility Index (UI) scores

    Time frame: 6 months

    To estimate the EQ-5D-5L UI scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.

  3. Visual Analog Scale (VAS) scores

    Time frame: 6 months

    To estimate the VAS scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.

  4. WPAI scores

    Time frame: 6 months

    To estimate the WPAI scores and their change across six time points in a span of six months following the test-confirmed COVID-19 or influenza.

Secondary outcomes

  1. Prevalence 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).

  2. Prevalence, Severity, and duration of influenza symptoms aggregated as index score area under the curve

    Time frame: 6 Months

    To characterize prevalence and duration of influenza symptoms before influenza and up to 6 months (acute phase and Long Flu). Outcome will be aggregated by assigning a point-scale to the symptom severity and calculating the area under the curve of the severity index score.

  3. Fatigue before COVID-19

    Time frame: 6 months

    To assess fatigue (using PROMIS questionnaire Fatigue short-form 8a) before COVID-19 and over a six-month follow-up.

  4. Fatigue after COVID-19

    Time frame: 6 months

    To estimate the PROMIS questionnaire Fatigue short-form 8a score and its change across six time points in a span of six months following the RT-PCR confirmed COVID-19.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • CVS Caremark

Registry information

Official study title

Patient-Reported Outcomes Associated With COVID-19 and Influenza: A Prospective Survey Study on Outpatient Symptomatic Adults With Test-Confirmed Illness in the United States

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2021
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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