NCT04377620终止3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 211
- 试验地点
- 36
- 主要终点
- Percentage of Participants Who Have Died Due to Any Cause
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS) who require mechanical ventilation.
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 blinded
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant or guardian health proxy must provide informed consent before any study assessment is performed.
- •Male or female participants aged ≥ 12 years.
- •Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to randomization by any test with local regulatory approval.
- •Participants who are intubated and receiving mechanical ventilation due to COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of randomization.
- •Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest x-ray or CT scan.
排除标准
- •Known history of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
- •Presence of severely impaired renal function defined by estimated creatinine clearance < 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the updated bedside Schwartz equation. Participants must not be receiving CRRT or intermittent hemodialysis at screening.
- •In the opinion of the investigator, unlikely to survive for > 24 hours from randomization.
- •Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
- •Currently receiving ECMO.
- •Participant may not be sharing a ventilator, or co-ventilating, with any other patient.
- •Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK inhibitor, within 7 days of randomization.
- •Treatment with a JAK inhibitor within 30 days of randomization.
- •Participants who are on long-term use of antirejection or immunomodulatory drugs.
- •Pregnant or nursing (lactating) women.
研究组 & 干预措施
Placebo + Standard of Care (SoC)
Placebo Comparator
Matching Placebo will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
干预措施: Placebo (Drug)
Ruxolitinib 5mg + Standard of Care (SoC)
Experimental
Ruxolitinib 5mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
干预措施: Ruxolitinib (Drug)
Ruxolitininb 15mg + Standard of Care (SoC)
Experimental
Ruxolitinib 15mg will be administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Percentage of Participants Who Have Died Due to Any Cause
时间窗: Study start to Day 29
To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.
次要结局
- Number of Ventilator Free Days(Study start to Day 29)
- Oxygen Free Days(Study start to Day 29)
- Vasopressor Free Days(Study start to Day 29)
- Hospital Free Days(Study start to Day 29)
- Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale(Study start to Days 15 and 29)
- Number of ICU Free Days(Study start to Day 29)
- Percentage of Participants With the COVID-19 Ordinal Scale Reported(Study start to Day 29)
- Change in SOFA Score(from baseline to Days 3, 5, 8, 11, 15, and 29)
- Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale(Study start to Days 15 and 29)
- Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events(Study start to Day 29)
- Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale(Study Start to Day 29)
- Change in the COVID-19 9-point Ordinal Scale(Study start to Days 15 and 29)
研究者
研究点 (36)
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