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临床试验/NCT05144178
NCT05144178Unknown不适用

Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab ) as Part of Emirats Health Service (EHS)Fighting Strategy Against COVID-19.

Emirates Health Services (EHS)1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2021年11月14日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,500
试验地点
1
主要终点
percent of hospital admission from total number of reviewed patient

研究概览

简要总结

Sotrovimab is a newly developed monoclonal antibody for the treatment of mild and moderate COVID-19 patient, who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions.

The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

As the clinical trial results are too preliminary for the drug to enter routine use in UAE the drug approved only for emergency use, until further evidence shows Sotrovimab is effective, so we thought about this study as a tool to assess the success of Emirats Health service (EHS) strategy for fighting against COVID-19 outside the hospital setting.

详细描述

May 26, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19), as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

May 28,2021 the UAE Ministry of Health and Prevention approved the investigational drug for emergency use, and Emirats health service considered strategy for fighting against COVID-19 outside the hospital setting, based on this strategy ,special protocol was finalized and approved including initiation of infusion units for the drug in EHS hospital and primary health care centers, all Infection Prevention and Control Precautions were taken inconsideration .

The overall aim of this study is to determine the effectiveness of Sotrovimab infusion in cohort of ambulatory patients with early symptomatic COVID-19 at high risk for hospitalization, in UAE. We expect to assess the Proportion of patients who have progression of COVID-19 through 28 days as defined by visit to a hospital emergency room for management or illness, or hospitalization more than 24 h for acute management of illness or death. files of patients treated from June 2021 till October 2021 will be reviewed and data will be collected based on the protocol approved from MOHAP ethical committee.

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
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All cases received Sotrovimab according the EUA protocol.
  • All patient aged 13 and above

排除标准

  • Sever form of the COVID-19 disease
  • Hospitalized patient
  • Age less than 13 years old
  • BMI less than 25 and no risk factors

结局指标

主要结局

percent of hospital admission from total number of reviewed patient

时间窗: 10 days

Admission to hospital with progressive COVID -19 more than 24h

percent of Death among total number of reviewed patient

时间窗: 28 days

mortality post treatment

次要结局

未报告次要终点

研究者

发起方
Emirates Health Services (EHS)
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Sumaya Abdalateef

Clinical Director

Emirates Health Services (EHS)

研究点 (1)

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