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 in VA Health System 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
- 5,814
- 试验地点
- 1
- 主要终点
- Hospitalization 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 EUA-eligible patient population in the Department of Veterans Affairs (VA) 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 the VA 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 to access EVUSHELD use under the EUA.
排除标准
- 未提供
研究组 & 干预措施
EVUSHELD arm
Individuals given EVUSHELD for prophylaxis
干预措施: Evusheld (Drug)
结局指标
主要结局
Hospitalization due to COVID-19
时间窗: up to 6 months
Hospital record of patient admission
All-cause mortality
时间窗: Up to 6 months
All-cause deaths
次要结局
- Documented SARS-COV-2 infection(up to 6 and 12 months)
- Medically attended COVID-19(up to 6 and 12 months)
- COVID-19 hospitalisation(up to 12 months)
- COVID-19 Intensive Care Unit (ICU) admisssion(up to 6 and 12 months)
- COVID-19-related mortality(up to 6 and 12 months)