EUCTR2020-001162-12-DE进行中（未招募）1 期
An adaptive phase 3, randomized, double-blind, placebo-controlled, study assessing efficacy and safety of sarilumab for hospitalized patients with COVID-19
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants must be =18 years of age
- •Participants must be hospitalized for less than or equal to 7 days with
- •evidence of pneumonia and have one of the following disease categories:
- •severe disease or critical disease
- •Laboratory-confirmed SARS-CoV-2 infection
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 176
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 264
排除标准
- •Unlikely to survive after 48 hours from screening or unlikely to remain at
- •the investigational site beyond 48 hours. Patients with multi organ dysfunction or requiring extracorporeal life support or renal replacement
- •therapy are excluded.
- •Presence of neutropenia less than 2000/mmˆ3, AST or ALT greater than
- •5 X ULN, platelets less than 50,000/mmˆ3
- •Prior immunosuppressive therapies
- •Use of chronic oral corticosteroids for non-COVID-19 related condition
- •Known or suspected history of tuberculosis
- •Suspected or known active systemic bacterial or fungal infections
研究者
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