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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Participants who received nirmatrelvir-ritonavir Patients with cardio-pulmonary conditions
  • Drug: nirmatrelvir-ritonavir
    Paxlovid standard of treatment care
    Other names:
    • Paxlovid
Participants who did not received nirmatrelvir-ritonavir Patients with cardio-pulmonary conditions

Recruiting Locations

More Details

NCT ID
NCT07090486
Status
Completed
Sponsor
Pfizer

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.