An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among Immunocompromised Patients in Israel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Hospitalisation due to COVID-19
研究概览
简要总结
An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EVUSHELD eligible patient population in the Clalit Health Services in Israel.
详细描述
This a Phase IV observational, secondary data study to assess the effectiveness of EVUSHELD in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.
The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EVUSHELD eligible patient population in the Clalit Health Services in Israel.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •With evidence of COVID 19 (i.e., a positive diagnostic test, or COVID-19 diagnosis code) in the period of 90 days before (pseudo) index date OR
- •With evidence of SARS-CoV-2 infection on the (pseudo) index date or anytime within the 6-day period immediately following this date (i.e., index date to index date+6)
研究组 & 干预措施
EVUSHELD Arm
Individuals given EVUSHELD for pre-exposure prophylaxis
干预措施: EVUSHELD (Drug)
结局指标
主要结局
Hospitalisation due to COVID-19
时间窗: up to 6 months
Any record of admission to hospital that was reported to the Israeli MOH as hospitalization due to SARS-CoV-2
All-cause mortality
时间窗: up to 6 months
All-cause deaths reported in the patient's record
次要结局
- COVID-19 mortality(6 months and 12 months)
- COVID-19-related healthcare resource utilization (HCRU)(6 months)
- COVID-19-related healthcare resource utilization(6 months)
- Documented SARS-CoV-2 Infection, COVID-19 related mortality, Severe COVID-19(6 months and 12 months)
- SAEs/AESIs(6 months)
- Adverse events (AEs)(12 months)