NCT05702788撤回2 期
A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Study to Evaluate the Efficacy and Safety of Jaktinib Hydrochloride Tablets in Participants Receiving the Best Available Treatment for Severe Novel Coronavirus Pneumonia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The proportion of Participants who develop death or respiratory failure.
研究概览
简要总结
This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 168 eligible patients with severe novel coronavirus pneumonia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age, male or female;
- •The Participants was diagnosed with novel coronavirus pneumonia;
- •It meets the heavy-duty standards of the new coronavirus pneumonia diagnosis and treatment protocol (version 9).
- •Participants who voluntarily sign informed consent.
- •The National Institute of Allergy and Infectious Diseases Sequential Scale (NIAID-0S) score is 5 or 6;
排除标准
- •Participants who cannot take orally, or are suspected to be allergic to Jaktinib, similar drugs or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
- •Participants who have received the following treatments within the specified time window before randomization:
- •Participants have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid;
- •Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half lives at random;
- •Immune deficiency;
研究组 & 干预措施
Jaktinib 75mg BID
Experimental
Jaktinib 75mg BID
干预措施: Jaktinib hydrochloride tablets (Drug)
Jaktinib 100mg BID
Experimental
Jaktinib 100mg BID
干预措施: Jaktinib hydrochloride tablets (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
The proportion of Participants who develop death or respiratory failure.
时间窗: 28 days after randomization
Respiratory failure is defined as Participants who on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation(ECMO) or on non-invasive ventilation or high-flow oxygen devices.
次要结局
- The proportion of Participants who develop death or respiratory failure.(14 days after randomization)
研究者
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