Impact of Nirmatrelvir-ritonavir on Changes in Healthcare Utilization and Frailty Following COVID-19: a Difference-in-difference Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 14,000
- 试验地点
- 1
- 主要终点
- Cardio-pulmonary Measurement A: Change in rate of cardiopulmonary-related healthcare utilization in patients that received nirmatrelvir-ritonavir compared to not received.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Participants who received nirmatrelvir-ritonavir
Patients with cardio-pulmonary conditions
干预措施: nirmatrelvir-ritonavir (Drug)
结局指标
主要结局
Cardio-pulmonary Measurement A: Change in rate of cardiopulmonary-related healthcare utilization in patients that received nirmatrelvir-ritonavir compared to not received.
时间窗: 180 days before COVID-19 symptoms to 180 days after or 365 days after
次要结局
- 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.)