NCT05672888尚未招募2 期
Efficacy and Safety of Jaktinib in Patients With COVID-19 Pneumonia.
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to Recovery
研究概览
简要总结
This was a randomized, double-blind, placebo-controlled parallel study.
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;
- •History of COVID-19 infection within 1 week;
- •Subjects with HRCT consistent with viral pneumonia (Judged by investigator) and meeting any of the following criteria: With fever, respiratory symptoms; Shortness of breath present,RR ≥30 breaths/min.
- •Clear consciousness, Capable and voluntary informed consent.
排除标准
- •Unable to take tablets orally Or suspected hypersensitivity to Jaktinib, drugs of the same class, or their excipients, Patients with severe gastrointestinal dysfunction affecting drug absorption;
- •Any person meeting criteria for critical pneumonia;
- •Patients considered unsuitable for this trial by the investigator.
研究组 & 干预措施
Jaktinib
Experimental
Jaktinib 100mg BID
干预措施: Jaktinib (Drug)
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Recovery
时间窗: Day 1 to Day 28
Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. NIAID-OS: 1 Not hospitalized, no limitations on activities. 2 Not hospitalized, limitation on activities and/or requiring home oxygen. 3 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
次要结局
- Percentage of participants who require invasive mechanical ventilation due to disease progression at Day 3, 7, 1 4 or EOT(Day 3, 7, 14 or EOT)
- Mortality(Day 1 to Day 28)
研究者
研究点 (1)
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