NCT04500132已完成2 期
Phase 2, Multi-center, Randomized, Double-blind, Placebo- Controlled Study to Evaluate the Safety and Efficacy of EC-18 in COVID-19 Infection to Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Rate of transition to ARDS
研究概览
简要总结
Prevention of COVID-19 infection to severe pneumonea or ARDS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Male or female age 19 years or older
- •Pathologically confirmed diagnosis of COVID-19 Infection to Pneumonia
排除标准
- •Pathologically confirmed diagnosis of bacterial pneumonia or viral pneumonia
- •Pregnant or nursing at the time of signing informed consent
- •Known sensitivity to any study medication
- •Unwilling or unable to complete study diary
- •Any other condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the protocol
研究组 & 干预措施
Placebo Arm
Placebo Comparator
Placebo EC-18 QD
干预措施: Placebo EC-18 (Drug)
EC-18 Arm
Experimental
EC-18 QD
干预措施: EC-18 (Drug)
结局指标
主要结局
Rate of transition to ARDS
时间窗: 14 days after starting IP administration
次要结局
未报告次要终点
研究者
研究点 (1)
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