COVID-19
Conditions
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
Brief summary
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.
Interventions
Paxlovid standard of treatment care
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardio-pulmonary Measurement A: Change in rate of cardiopulmonary-related healthcare utilization in patients that received nirmatrelvir-ritonavir compared to not received. | 180 days before COVID-19 symptoms to 180 days after or 365 days after |
Secondary
| Measure | Time frame |
|---|---|
| Frailty Measurement A: Change in frailty measured by Frailty score Median (IQR) in patients that did receive in patients nirmatrelvir-ritonavir compared to not received. | During Pre-period: 12 months prior to symptom onset Frailty score Median (IQR) to 12 months after. |
Countries
United States
Outcome results
None listed