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
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-19This 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 totake part in the study. Participant will be emailed a form with questions about theirhealth 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.

Recruiting
COVID-19
Coronavirus Disease 2019
Influenza

Biological: COVID-19 Vaccine

Receipt of Pfizer BioNTech COVID-19 vaccine

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

CVS Health
Woonsocket, Rhode Island, United States

Contacts

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
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
MeSH Terms
COVID-19
Influenza, Human
Coronavirus Infections