NCT05688839尚未招募2 期
A Second Study to Assess the Efficacy and Safety of Jaktinib Hydrochloride Tablets in the Treatment of 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
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy of Jaktinib
研究概览
简要总结
A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 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
- •Aged ≥18 years old, regardless of gender;
- •There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1-2 weeks;
- •HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator)
- •Participants who voluntarily sign informed consent.
排除标准
- •Participants who cannot take orally, or are suspected to be allergic to Jaktinib hydrochloride, similar drugs, or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
- •Critical pneumonia Participants with other organ failure requiring ICU monitoring and treatment;
- •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;
- •Participants who have received the novel coronavirus vaccine within 1 week before randomization;
- •Prior to randomization, there were the following active and uncontrolled infections: tuberculosis, HIV, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than SARS CoV-2 that required systemic anti-infection treatment;
- •Renal diseases requiring dialysis treatment;
- •Pregnant and lactating women;
- •Any other Participants that were considered unsuitable by the investigator.
研究组 & 干预措施
Jaktinib 100mg BID
Experimental
Jaktinib hydrochloride tablets, 2 x 50mg dosage, BID
干预措施: Jaktinib hydrochloride tablets (Drug)
Placebo
Placebo Comparator
2 x Placebo tablets, BID
干预措施: placebo (Drug)
结局指标
主要结局
Efficacy of Jaktinib
时间窗: 28 days after randomization
The proportion of subjects whose chest High-Resolution CT (HRCT) showed significant absorption of pulmonary inflammation (definition of significant absorption: the lung inflammatory lesions were reduced by more than 50%) at 7, 14 days after treatment until EOT
次要结局
- Safety of Jaktinib(Up to 2 months after randomization)
研究者
研究点 (1)
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