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NCT05160636 | RECRUITING | COVID-19

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

Pfizer

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.

Condition or disease

COVID-19

Coronavirus Disease 2019

Influenza

Intervention/treatment

COVID-19 Vaccine

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 999 participants
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
Actual Study Start Date : 2022-01-31
Estimated Primary Completion Date : 2025-09-17
Estimated Study Completion Date : 2025-09-17

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study to Look at the Health Outcomes of Patients With COVID-19 and Influenza

Location Details

NCT05160636

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Rhode Island

CVS Health

Living socket, Rhode Island, United States, 02895