Official Title
Impact of Nirmatrelvir-ritonavir on Changes in Healthcare Utilization and Frailty Following COVID-19: a Difference-in-difference Analysis
Brief Summary

This is a cohort study that will include Paxlovid (nirmatrelvir-ritonavir) treatmenteligible for people with a positive SARS-CoV-2 diagnostic test and at least one COVID-19symptom. This study will look at the change in Post Covid Conditions measured by thenumber of outpatients, Emergency department, urgent care and inpatient visits before andafter COVID-19 between those who did and did not receive Paxlovid. In addition, changesin frailty post-acute infection will be evaluated, in a separate analysis. It ishypothesized that individuals with COVID-19 who received Paxlovid will have a smallerpost-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

Not Provided

Completed
COVID-19

Drug: nirmatrelvir-ritonavir

Paxlovid standard of treatment care
Other Name: Paxlovid

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Pfizer New York
New York, New York, United States

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
Keywords
Coronavirus-19 disease (COVID-19)
Kaiser Permanente Southern California (KPSC)
post-COVID conditions (PCC)
Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
long COVID
Nirmatrelvir-Ritonavir
MeSH Terms
COVID-19
Ritonavir
Nirmatrelvir
Nirmatrelvir and ritonavir drug combination