Clinical trial NCT05160636: A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: CVS Caremark
First posted: 2021-12-16
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are 18 years or older who are self-reported symptomatic, who tested positive with RT-PCR at any of the approximately 5,000 CVSH COVID-test sites and consented to participate in the PRO study from mid-October 2021 through mid-January 2022 or when enrollment reaches 600

Updated study analysis included participants 18 years or older who are self-reported symptomatic, with test-confirmed illness when tested at any of CVS pharmacy COVID-19 or influenza test sites, and consent to participate in the study.

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 (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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Health Related Quality of Life (HRQoL) using EQ-5D-5L
timeFrame: 6 months
measure: EQ-5D-5L Utility Index (UI) scores
timeFrame: 6 months
measure: Visual Analog Scale (VAS) scores
timeFrame: 6 months
measure: WPAI scores
timeFrame: 6 months
Secondary outcomes:
measure: Prevalence and duration of SARS-CoV-2 symptoms
timeFrame: 6 months
measure: Prevalence, Severity, and duration of influenza symptoms aggregated as index score area under the curve
timeFrame: 6 Months
measure: Fatigue before COVID-19
timeFrame: 6 months
measure: Fatigue after COVID-19
timeFrame: 6 months
Other outcomes:
Locations:
city: Woonsocket
country: United States
facility: CVS Health
state: Rhode Island
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: