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

NCT ID: NCT05160636

Last Updated: 2025-12-24

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

ACTIVE_NOT_RECRUITING

Total Enrollment

999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-31

Study Completion Date

2026-02-28

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 (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

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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.

Conditions

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COVID-19 Coronavirus Disease 2019 Influenza

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COVID-19 Positive

Test-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

Test-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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CVS Caremark

INDUSTRY

Sponsor Role collaborator

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

Locations

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Pfizer

New York, New York, United States

Site Status

Countries

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United States

References

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Sun X, Di Fusco M, Lupton LL, Yehoshua A, Alvarez MB, Allen KE, Puzniak L, Lopez SMC, Cappelleri JC. Predictors of Long COVID Among Symptomatic US Adults Testing Positive for SARS-CoV-2 at a National Retail Pharmacy. Healthcare (Basel). 2024 Nov 21;12(23):2321. doi: 10.3390/healthcare12232321.

Reference Type DERIVED
PMID: 39684943 (View on PubMed)

Di Fusco M, Cappelleri JC, Yehoshua A, Craig KJT, Alvarez MB, Allen KE, Porter TM, Lopez SMC, Puzniak L, Sun X. Associations between symptom-based long COVID clusters and long-term quality of life, work and daily activities among individuals testing positive for SARS-CoV-2 at a national retail pharmacy. J Patient Rep Outcomes. 2024 Oct 22;8(1):122. doi: 10.1186/s41687-024-00797-7.

Reference Type DERIVED
PMID: 39436613 (View on PubMed)

Sun X, Di Fusco M, Puzniak L, Coetzer H, Zamparo JM, Tabak YP, Cappelleri JC. Assessment of retrospective collection of EQ-5D-5L in a US COVID-19 population. Health Qual Life Outcomes. 2023 Sep 8;21(1):103. doi: 10.1186/s12955-023-02187-x.

Reference Type DERIVED
PMID: 37679771 (View on PubMed)

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4591034

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

Other Identifiers

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NCT05160636

Identifier Type: REGISTRY

Identifier Source: secondary_id

C4591034

Identifier Type: -

Identifier Source: org_study_id