NCT05686629尚未招募2 期
A 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
- 120
- 试验地点
- 1
- 主要终点
- Efficacy of Jaktinib
研究概览
简要总结
This study adopts a randomized, double-blind, placebo parallel control design, and is expected to include 120 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years old (including threshold), regardless of gender;
- •There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1 week;
- •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 patients 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 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: Jaktinib hydrochloride tablets (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
Time interval from randomization to discharge
时间窗: up to 28 days after randomization
次要结局
- Safety of Jaktinib(up to 2 months after randomization)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.Acute Pain From Ankle Sprain or StrainNCT02089425Kowa Research Institute, Inc.384
已完成
不适用
A Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in ChildrenElevated Blood Lead LevelsNCT04891666Novozymes A/S66
已完成
不适用
The Combined Seed Extracts of Cassia Obtusifolia Linne and Foeniculum Vulgare Mill in Patients With Chronic ConstipationChronic ConstipationNCT05548842Pusan National University Yangsan Hospital100
已完成
1 期
Influenza Vaccine Challenge Study in Healthy SubjectsInfluenzaNCT01226758PepTcell Limited32
已完成
2 期
Study to Evaluate the Safety and Efficacy of JVS-100 Administered to Adults With Critical Limb IschemiaCritical Limb IschemiaNCT01410331Juventas Therapeutics, Inc.48