An Observational Study to Describe EVUSHELD™ (Tixagevimab/Cilgavimab) Pre-exposure Prophylaxis in Real-world Setting in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 397
- 试验地点
- 1
- 主要终点
- Demographics and clinical characteristics of patients received Evusheld as PrEP
研究概览
简要总结
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
详细描述
This is an observational, cohort study that will use secondary data to describe the baseline demographics and clinical characteristics in patients who received EVUSHELD as PrEP against SARS-CoV-2 infection/COVID-19 in Japan.
All patients who have a record of administration of EVUSHELD in the database will be included in the study. The index date will be defined as the date of first EVUSHELD administration in the database (Day 0) and the patients will be followed up to 6 months after the index date (Day 1 to 180). The look back period is defined as the 12-month period prior to index date (Day -360 to -1). The exposure of interest will be defined as the administration of EVUSHELD for use as PrEP against COVID-19. As the result of feasibility assessment, sample size of the study expected to be approximately 280.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunocompromised patients who were administrated EVUSHELD as PrEP and have administration date of EVUSHELD
- •patients aged ≥ 12 years at the index date
排除标准
- •Patients who have no medical visit records at any time in the 12 months preceding the index date
研究组 & 干预措施
Evusheld administered group
干预措施: Evusheld (Drug)
结局指标
主要结局
Demographics and clinical characteristics of patients received Evusheld as PrEP
时间窗: Up to 360 days before the date of first administration of Evusheld
Proportion of patients by age, gender, and clinical characteristics of interest (i.e. comorbidity, concurrent medication) between 360 days from the date of first administration of Evusheld (index date) to the index date will be described.
次要结局
- COVID-19 hospitalization(Up to 180 days after the date of first administration of Evusheld)
- All cause mortality(Up to 180 days after the date of first administration of Evusheld)
- Medically attended COVID-19(Up to 180 days after the date of first administration of Evusheld)
- In-hospital mortality due to COVID-19(Up to 180 days after the date of first administration of Evusheld)