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

NCT ID: NCT06163677

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-17

Study Completion Date

2024-01-17

Brief Summary

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

Detailed Description

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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.

Conditions

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COVID-19 Coronavirus Disease 2019 Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 Positive

Laboratory-confirmed COVID-19 illness and at least one patient-reported symptom

COVID-19 Vaccine

Intervention Type BIOLOGICAL

Receipt of Pfizer BioNTech COVID-19 vaccine

Influenza Positive

Laboratory-confirmed influenza illness and at least one patient-reported symptom

No interventions assigned to this group

Interventions

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COVID-19 Vaccine

Receipt of Pfizer BioNTech COVID-19 vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4591064

To obtain contact information for a study center near you, click here.

Other Identifiers

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C4591064

Identifier Type: -

Identifier Source: org_study_id

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