A REAL-WORLD STUDY ON THE EFFECTIVENESS OF NIRMATRELVIR-RITONAVIR IN REDUCING SEVERE OUTCOMES FROM COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 99,000
- 试验地点
- 2
- 主要终点
- Time to the first severe composite outcome (all-cause hospital admission, ICU admission, or death) within 30 days of treatment assessment.
研究概览
简要总结
The purpose of this study is to learn about the effects of the study medicine called Paxlovid [nirmatrelvir-ritonavir/PF-07321332], for the potential treatment of COVID-19.
This study will use patient health records in Ontario, to find people who were sick with COVID-19 and visited a pharmacist to be treated, anytime from December 1st, 2022, to March 31st, 2024. To be included in our study, the people must be over 18 years of age and be registered in the Ontario health system for at least one year. People were not included in our study if they have been pregnant in the past year or have serious kidney or liver disease.
We will separate the people in the study into two groups: those who received treatment with Paxlovid [nirmatrelvir-ritonavir/PF-07321332] and those who received no treatment. We will monitor their healthcare visits or if they die for any reason, for up to 60 days after the date that they visited their pharmacist. Then we will compare participant experiences when they are taking the study medicine to when they are not. This will help us determine if the study medicine is effective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Record of at least 1 nirmatrelvir-ritonavir prescription and at least 1 dispensation issued by the pharmacist (Treated Cohort only) within 5 days of prescription, identified through pharmacy billing codes
- •Record of at least 1 assessment for nirmatrelvir-ritonavir, without a prescription issued by the pharmacist (Untreated Cohort only), OR record of at least 1 prescription for nirmatrelvir-ritonavir without dispensation (Untreated Cohort only), identified through pharmacy billing codes
- •Invalid or incomplete records (e.g., missing age, missing sex, death before index)
- •Record of a positive PCR test for SARS-CoV-2 between 5 and 90 days prior to the index date
- •Had a prescription for antivirals within 3 days prior to or on the index date
排除标准
- 未提供
研究组 & 干预措施
Assessed and Untreated Cohort
Participants who were assessed with Covid for nirmatrelvir-ritonavir but either were not prescribed the medication or did not have it dispensed during the selection period
干预措施: No treatment (Other)
Assessed and Treated Cohort
Participants who were assessed with Covid prescribed and subsequently dispensed nirmatrelvir-ritonavir during the selection period
干预措施: nirmatrelvir-ritonavir (Drug)
结局指标
主要结局
Time to the first severe composite outcome (all-cause hospital admission, ICU admission, or death) within 30 days of treatment assessment.
时间窗: Participants selected between 01 Dec, 2022 to 31 March 2024
次要结局
- Time to the first severe composite outcome (all-cause hospital admission, ICU admission, or death) within 60 days of treatment assessment.(Participants selected between 01 Dec, 2022 to 31 March 2024)