NCT04847583终止2 期
A Phase 2 Open-Label, Randomized Controlled Trial to Evaluate the Biomarker Change, Efficacy, Pharmacokinetics, Safety and Tolerability of Telacebec in Participants With Moderate COVID-19 Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- Biomarker change
研究概览
简要总结
This is a Phase 2, open-label, randomized controlled trial to determine the effects of Telacebec (Q203) on inhibition of leukotriene production, clinical change, pharmacokinetics, and safety in participants with moderate COVID-19 disease
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
- None
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
- •Provide written, informed consent prior to all study-related procedures.
- •Provide written, informed consent to undergo Human Immunodeficiency Virus (HIV) testing.
- •Willingness and ability to attend scheduled visits and undergo study assessments.
- •Able and willing to measure their oxygen saturation level and temperature, record their COVID-19 symptoms and complete a patient diary.
- •Male or female aged 18 years or older.
- •Confirmed and documented SARS-CoV-2 infection, defined as RT-PCR laboratory confirmation.
- •Clinical and/or radiological findings indicative of moderate COVID-19 disease
排除标准
- •Severe or critical COVID-19 disease at enrollment (Day 1) (per NIH Treatment Guideline categorization) as determined by the Investigator.
- •Inability to swallow oral medication.
- •Concurrent known asthma, active tuberculosis or tuberculosis within the last 3 months, or any other condition that could compromise the well-being of the participant, or prevent, limit or confound protocol specified assessments, in the opinion of the Investigator.
- •Female Participant who is pregnant, breast-feeding, or planning to conceive a child within the anticipated period of participating in the study or within 6 months after last dose of study medication. Males planning to conceive a child during the study or within 6 months of cessation of treatment.
研究组 & 干预措施
Telacebec (Q203) with COVID-19 standard of care (SoC)
Experimental
干预措施: Telacebec (Drug)
Telacebec (Q203) with COVID-19 standard of care (SoC)
Experimental
干预措施: COVID-19 Standard of care (Drug)
COVID-19 Standard of care (SoC)
Active Comparator
干预措施: COVID-19 Standard of care (Drug)
结局指标
主要结局
Biomarker change
时间窗: Day 1 and 14
Percentage Inhibition of whole blood Leukotriene B4 (LTB4) production at 4 hours post dose SoC versus SoC plus telacebec
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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