Bi-directional Real-world Cohort Study on Sotrovimab and Its Impact on the Strength and Duration of the Immune Response to Natural SARS-CoV-2 Infection in Real-life Setting in the UAE and the Kingdom of Bahrain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.
研究概览
简要总结
The United Arab Emirates (UAE), the Kingdom of Bahrain, Kuwait, Oman, and Qatar have authorised sotrovimab for emergency use. Local experience among physicians include recent successful COVID-19 vaccine pivotal studies supported by the authorities' willingness to expedite understanding of the role of monoclonal antibodies such as sotrovimab in the management of COVID-19 and expertise to integrate the latest knowledge into the local or regional COVID-19 management guidelines. The aim of this study is to collect local clinical evidence for sotrovimab effect in the real-life setting in the UAE and the Kingdom of Bahrain. Overall study population is 20,000 and the duration of the study will be approximately six months from recruitment date.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Adults and paediatric patients (≥ 12 years of age weighing at least 40 kg)
- •Mild-to-moderate COVID-19
- •Positive results of direct SARS-CoV-2 viral testing
- •High risk for progression to severe COVID-19
排除标准
- •Patients who are hospitalised due to COVID-19 before sotrovimab administration
- •Patients who require oxygen therapy due to COVID-19 before sotrovimab administration oPatients who received pharmacological treatment including monoclonal antibodies to any components of SARS-CoV-2 virus within 6 months prior to enrolment into the study in retrospective and prospective arms.
研究组 & 干预措施
Sotrovimab Arm
干预措施: Sotrovimab (Drug)
结局指标
主要结局
To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.
时间窗: 6 months
Defined as • Change from baseline in mean levels of elevated SARS-CoV-2 functional neutralising antibodies at Day 29, Day 60 and Day 180 after sotrovimab administration, these will be presented as proportion of patients with that response
• Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration:
时间窗: 6 months
* Proportion of patients with COVID-19 progression through Day 29 after sotrovimab administration: * Requiring supplemental oxygen * Requiring ICU and/or general ward admission * Death * Time to first PCR negative status after the COVID-19 symptom onset * Time to first PCR negative status after date of sotrovimab administration
次要结局
- To assess the safety of sotrovimab in real-life setting in the UAE and Bahrain(6 months)
- To evaluate the impact of sotrovimab on the duration and the severity of COVID-19 clinical symptoms(6 months)
- To evaluate the impact of sotrovimab in reducing SARS-CoV-2 viral load and in preventing COVID-19 respiratory disease progression.(6 months)
- To assess the impact of sotrovimab on the strength and duration of the immune response to natural SARS-CoV-2 infection in real-life setting in the UAE and Bahrain.(6 months)