NCT04447404终止2 期
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of DUR-928 in Subjects Infected With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Durect
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Composite Endpoint of Alive and Free of Organ Failure at Day 28
研究概览
简要总结
Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Hospitalized with moderate, severe, or early critical COVID-19 illness diagnosed by RT- PCR
- •Acute liver injury (including acute on chronic liver disease) or acute kidney injury or moderate COVID-19 pneumonia
排除标准
- •Critical COVID-19 illness (MAP < 60 mm Hg, on mechanical ventilator for ≥ 5 days)
- •On maintenance hemodialysis or peritoneal dialysis
- •Child Pugh C cirrhosis
- •Hepatorenal syndrome
- •Ascites and/or hepatic encephalopathy
- •History of end stage renal disease or CKD with eGFR < 15 mL/min/1.73m2
- •Women who are pregnant or breast feeding
- •Receipt of other concomitant experimental therapies
研究组 & 干预措施
DUR-928
Experimental
干预措施: DUR-928 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Composite Endpoint of Alive and Free of Organ Failure at Day 28
时间窗: Day 28
Free of mechanical ventilation, free of renal replacement therapy and free of acute liver failure
次要结局
- Alive at Days 28 and 60(Day 28 and Day 60)
- Alive, Out of Hospital, at Days 28 and 60(Day 28 and Day 60)
- Alive, Out of ICU, at Day 28(Day 28)
研究者
研究点 (1)
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