NCT04565379已完成2 期
A Randomized, Double Blind, Placebo-controlled, Phase 2 Clinical Trial to Investigate the Efficacy and Safety of 2 Doses of NuSepin® Intravenous Infusion in COVID-19 Pneumonia Patients
Shaperon5 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年9月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 5
- 主要终点
- Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
研究概览
简要总结
A randomized, double blind, placebo-controlled, phase 2 clinical trial to investigate the efficacy and safety of 2 doses of NuSepin® intravenous infusion in COVID-19 pneumonia patients
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NuSepin® 0.1 mg
Active Comparator
NuSepin® 0.1 mg/kg in 100 ml normal saline infusion
干预措施: NuSepin® 0.1 mg (Drug)
NuSepin® 0.2 mg
Active Comparator
NuSepin® 0.2 mg/kg in 100 ml normal saline infusion
干预措施: NuSepin® 0.2 mg (Drug)
Placebo
Placebo Comparator
100 ml normal saline infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Difference in Time to Clinical Improvement (TTCI) between the 2 treatments and the placebo group (in days)
时间窗: Day 29
次要结局
- Duration (days) of supplemental oxygenation(Up to Day 29)
- Length of ICU stay (days)(Up to Day 29)
- Time to complete clinical remission OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours(Up to Day 29)
- Percentage of patients with CRP < 10 mg/L or < 30% decreases from baseline(Day 15 and Day 29)
- Duration (days) of mechanical ventilation(Up to Day 29)
- Duration (days) of extracorporeal membrane oxygenation(Up to Day 29)
- Number of incidence of treatment emergent adverse events (TEAEs) in 3 treatment groups(Day 15 and Day 29)
- Clinical Status assessed by the six-category ordinal scale at fixed time points(Day 1, 4, 9, 15 and 29)
- All-cause mortality(Up to Day 29)
- Length of hospital stay (days)(Up to Day 29)
研究者
研究点 (5)
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