A Study to Understand How the Use of Paxlovid Affected Healthcare Use in People With Pre-existing Conditions.

NCT ID: NCT07090486

Last Updated: 2025-07-29

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

COMPLETED

Total Enrollment

14000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-15

Study Completion Date

2025-04-15

Brief Summary

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This is a cohort study that will include Paxlovid (nirmatrelvir-ritonavir) treatment eligible for people with a positive SARS-CoV-2 diagnostic test and at least one COVID-19 symptom. This study will look at the change in Post Covid Conditions measured by the number of outpatients, Emergency department, urgent care and inpatient visits before and after COVID-19 between those who did and did not receive Paxlovid. In addition, changes in frailty post-acute infection will be evaluated, in a separate analysis. It is hypothesized that individuals with COVID-19 who received Paxlovid will have a smaller post-COVID-19 increase (vs pre-COVID) in PCC healthcare utilization (i.e., cardiopulmonary) in comparison to patients with COVID-19 who did not receive Paxlovid.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants who received nirmatrelvir-ritonavir

Patients with cardio-pulmonary conditions

nirmatrelvir-ritonavir

Intervention Type DRUG

Paxlovid standard of treatment care

Participants who did not received nirmatrelvir-ritonavir

Patients with cardio-pulmonary conditions

No interventions assigned to this group

Interventions

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nirmatrelvir-ritonavir

Paxlovid standard of treatment care

Intervention Type DRUG

Other Intervention Names

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Paxlovid

Eligibility Criteria

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Inclusion Criteria

* Developed at least one COVID-19 symptom between Apr 1, 2022 through Dec 31, 2023
* A positive lab-confirmed polymerase chain reaction (PCR) SARS-COV-2 test 5 days after symptom onset (primary analysis).
* Continuous enrollment in KPSC health plans for at least 1 year (allowing for a 31-day gap to account for potential delays in membership renewal) before the date of symptom onset
* Active membership in KPSC health plans for at least 31 days after the date of symptom onset
* Eligible for nirmatrelvir-ritonavir defined by age and CDC-defined risk factors for severe COVID-19

Exclusion Criteria

* Individuals on another medication that is contraindicated for treatment with nirmatrelvir-ritonavir defined as having any prescription drug claim in the 90 days prior to COVID-19 symptom onset
* Receipt of any COVID-19 antiviral (molnupiravir, remdesivir, nirmatrelvir/ritonavir) or monoclonal antibody treatment (bamlanivimab, bebtelovimab, casirivimab/imdevimab, cilgavimab/tixagevimab, otrovimab,) \<180 days prior to COVID-19 symptom onset
* Any positive SARS-CoV-2 test, including self-reported tests, \<180 days prior to COVID-19 symptom onset.
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

Locations

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Pfizer New York

New York, New York, United States

Site Status

Countries

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United States

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4671067

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

Other Identifiers

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C4671067

Identifier Type: -

Identifier Source: org_study_id

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