DAS181 for Severe COVID-19: Compassionate Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Improved clinical status
研究概览
简要总结
The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.
详细描述
Each eligible subject is treated with DAS181 for 10 days and observed for 28 days from the first day of administration.
From day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml) nebulized DAS181 is given. If DAS181 is given by twice a day, one vial containing 4.5 mg (3.5m1) DAS181 should be delivered with about 12-hour interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens
- •Severe COVID-19
- •If female, subject must not be pregnant or nursing.
- •Non-vasectomized males are required to practice effective birth control methods
- •Capable of understanding and complying with procedures as outlined in the protocol as judged by the Investigator and able to sign informed consent form prior to the initiation of any screening or study-specific procedures.
排除标准
- •ALT or AST> 8 x ULN
- •(ALT or AST> 3 x ULN) and (Total bilirubin> 2.5 x ULN or INR> 2.0 x ULN)
- •Female subjects who have a positive pregnancy test and are breastfeeding
- •Subjects using any other investigational antiviral drugs during the hospitalization before enrollment.
- •Subjects participating in other clinical trials
- •Subjects may be transferred to a non-participating hospital within 72 hours
- •People who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly
- •Severe underlying diseases affecting survival
- •Critical COVID-19 requiring mechanical ventilator at the time enrolled
研究组 & 干预措施
DAS181 Treatment
Nebulized DAS181 9mg/day (4.5 mg bid/day) for 10 days
干预措施: DAS181 (Drug)
结局指标
主要结局
Improved clinical status
时间窗: Day 14
Percent of subjects with improved clinical status
Return to room air
时间窗: Day 14
Percent of subjects return to room air
次要结局
- Discharge(Days 14, 21, 28)
- Death(Day 14, 21, 28)
- SARS-CoV-2 RNA(28 days)
研究者
Gong Zuojiong
Director, Department of Infectious Disease
Renmin Hospital of Wuhan University