An Observational Study to Assess the Real-world Effectiveness of EVUSHELD™ (Tixagevimab/Cilgavimab) as Pre-exposure Prophylaxis Against COVID-19 Among EVUSHELD-eligible Populations Receiving Care at UPMC in the United States
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 4,232
- 试验地点
- 1
- 主要终点
- All-cause mortality
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 EUA-eligible patient population in the University of Pittsburgh Medical Center (UPMC) Health System.
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 EUA-eligible patient population in UPMC health system
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receipt of EVUSHELD under the FDA EUA for EVUSHELD
- •Eligibility for assess Evusheld use under the EUA. -
排除标准
- 未提供
研究组 & 干预措施
EVUSHELD arm
3,000 Individuals given EVUSHELD for pre-exposure prophylaxis
干预措施: EVUSHELD (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 6 months
To assess the effectiveness of EVUSHELD as PrEP against all-cause mortality
COVID-19 hospitalisation
时间窗: 6 months
To assess the effectiveness of EVUSHELD as PrEP against COVID-19 hospitalisation
次要结局
- SARS-CoV-2 infection(6 & 12 months)
- Medically attended COVID-19(6 & 12 months)
- Medically attended acute COVID-19(6 & 12 months)
- COVID-19 hospitalisation(12 months)
- COVID-19 intensive care unit (ICU) admission(6 & 12 months)