Clinical Use of EVUSHELD as Pre-exposure Prophylaxis in Real-world Setting - A Multi-center Observational Prospective Study to Determine Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- baseline and repeat administration
研究概览
简要总结
Study on Clinical Use of EVUSHELD (AZD7442) as Pre-exposure Prophylaxis in the Real-world Setting - A Multi-Centre Observational Prospective Study to Determine the Utilization and Clinical Outcomes of EVUSHELD in Gulf Cooperation Council Countries
详细描述
Study on Clinical use of EVUSHELD (AZD7442) as pre-exposure prophylaxis in the Real-world Setting Observational Prospective Study to determine the utilization and Clinical Outcomes of EVUSHELD in GCC.
This will be a multi-country, multi-centre, single-arm, observational, prospective study using primary data collection to describe the demographic and clinical characteristics of patients who received the first dose of AZD7442 for the prevention of SARS-CoV-2 infection causing symptomatic COVID-19 illness. The study will be conducted in the hospital/centers that are authorized to administer AZD7442, agree to participate in the study, and wherein investigators have access to all medical records (electronic/paper) for individual patients. The physicians at the hospital/centers will make a decision to administer AZD7442 to patients according to the local regulations (including the prescribing information) and such a decision to use AZD7442 is independent of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals receiving their first dose of AZD7442 for the prevention of SARS-CoV-2 infection within the 30 days prior to study enrolment.
- •The ability or willingness to sign informed consent/assent forms
排除标准
- •Patients currently participating in interventional clinical trials of SARS-CoV-2 vaccines, other SARS-CoV-2 prophylactic interventions, or COVID-19 treatments.
- •Patients with an ongoing COVID-19 infection at the time of AZD7442 administration as judged by the study physician.
结局指标
主要结局
baseline and repeat administration
时间窗: 12 month
To describe the baseline and repeat administration(s) of AZD7442 for prevention of SARS-CoV-2 infection
Demographics
时间窗: 12 month
To describe the baseline demographic of individuals receiving AZD7442 for pre-exposure prophylaxis
clinical characteristics
时间窗: 12 month
To describe the clinical characteristics of individuals receiving AZD7442 for pre-exposure prophylaxis
次要结局
- COVID-19 risk behavior at time of AZD7442(12 Month)
- describe COVID-19-related healthcare resource utilization(12 Month)
- Incidence of SARS-CoV-2 infection(12 Month)
- Incidence of all-cause hospitalization and mortality(12 Month)
- Describe health-related quality of life(12 Month)