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
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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ACTIVE_NOT_RECRUITING
999 participants
OBSERVATIONAL
2022-01-31
2026-02-28
Brief Summary
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* 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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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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Keywords
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Study Design
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COHORT
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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CVS Caremark
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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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
Countries
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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.
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.
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.
Related Links
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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