jRCT2043210005已完成不适用
Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection (Clinical study of CL2020 in patients with acute respiratory distress syndrome associated with SARS-CoV-2 infection)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •SARS-CoV-2 positive patients by RT-PCR
- •Patients diagnosed with ARDS by Berlin definition
- •Patients who are intubated and under mechanical ventilatory control
排除标准
- •Patients managed by Extracorporeal Membrane Oxygenation (ECMO) or using ventilation techniques such as High Frequency Oscillatory Ventilation (HFOV)
- •Patients who are not expected to survive for about 72 hours
结局指标
主要结局
Safety
incidence of Adverse events (AEs), adverse drug reactions (ADRs)
Efficacy
时间窗: 4 weeks after administration
mortality up to 4 weeks after administration
次要结局
未报告次要终点
研究者
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