Official Title
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
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 totake part in the study. Participant will be emailed a form with questions about theirhealth related to COVID-19 or influenza during twelve follow-ups over a 6-month period.

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.

Withdrawn
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 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

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

Not Provided

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
COVID-19 Vaccines