NCT04367077终止2 期
A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease (COVID-19)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Healios K.K.
- 入组人数
- 206
- 试验地点
- 12
- 主要终点
- Ventilator-Free Days
研究概览
简要总结
Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria, requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or systemic infection
排除标准
- •Moribund subject who, in the opinion of the Investigator, is not expected to survive at least 48 hours and End-stage severe chronic lung disease
研究组 & 干预措施
MultiStem
Experimental
干预措施: MultiStem (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
Ventilator-Free Days
时间窗: Day 0 through Day 28.
Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0.
时间窗: Day 28
次要结局
- All-cause mortality(Day 60)
- Ranked hierarchical composite outcome of alive and ventilator-free(Day 28)
- Ventilator-free days(Day 0 through Day 60)
研究者
研究点 (12)
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