NCT04371367已完成2 期
A Double-blind, Randomized Study Versus Placebo of Avdoralimab (IPH5401), an Anti-C5aR Antibody, in Patients With COVID-19 Severe Pneumonia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Number of ventilator-free days at Day 28 (VFD28)
研究概览
简要总结
The primary objective of this trial is to improve the proportion of COVID-19 patients with severe pneumonia who no longer need to be hospitalized, and to reduce the need for and duration of mechanical ventilation in patients with COVID-19 pneumonia complicated by acute respiratory distress syndrome (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)
盲法说明
Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COVID-19 severe pneumonia patients need for oxygen therapy ≥ 5 l/min or high-flow oxygen therapy
- •COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring mechanical ventilation
排除标准
- •Pregnant woman
- •Uncontrolled sepsis of bacterial or fungal origin
结局指标
主要结局
Number of ventilator-free days at Day 28 (VFD28)
时间窗: day 28
Number of days without mechanical ventilation at Day 28 for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) Patients hospitalized in ICU
Clinical improvement using WHO ordinal scale
时间窗: day 28
improvement of WHO ordinal scale
次要结局
- Number of participants with treatment-related adverse events(day 28)
研究者
研究点 (2)
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