A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Proportion of subjects discharged from hospital
研究概览
简要总结
A phase 2, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19
详细描述
This is a phase 2, randomized, double-blind, placebo-controlled study of the safety and efficacy of STI-5656 (Abivertinib Maleate) in subjects hospitalized due to COVID-19 in Brazil. Subjects are randomized 3:1 STI-5656 to placebo. Subjects receive either 100 mg of STI-5656 or placebo daily for 7 days. Standard of care will be maintained for all subjects throughout the 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
- •Confirmed positive for COVID-19 by RT-PCR assay or equivalent
- •Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board (IRB) or independent ethics committee (IEC) approved consent form prior to participating in any study related activity. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27, 2020 (Updated on July 2, 2020) FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used
- •Able to swallow capsules
- •Willing to follow contraception guidelines
排除标准
- •Pregnant or breast feeding
- •Suspected uncontrolled active bacterial, fungal, viral, or other infection other than COVID-19
- •Treatment with a strong cytochrome p450 3A4 inhibitor or inducer within 7 days prior to Day 1
- •Received anti-rejection or immunomodulatory drugs within 14 days prior to Day 1
- •Concurrent participation in another clinical trial involving therapeutic interventions (observation studies are acceptable)
- •Any condition that confounds the ability to interpret data from the study
- •Any significant medical condition, laboratory abnormality, or psychiatric illness that would interfere with or prevent the subject from participating in the study
研究组 & 干预措施
STI-5656
STI-5656 (abivertinib maleate) capsules administered orally 100 mg QD for 7 days, in addition to standard of care
干预措施: STI-5656 (Drug)
Placebo
Placebo capsules administered orally daily for 7 days, in addition to standard of care
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects discharged from hospital
时间窗: Randomization through Day 29
Proportion of subjects whoa re alive and discharged from the hospital by Day 29
次要结局
- AUC of STI-5656 (PK)(Randomization through Day 8)
- Incidence of adverse events (safety)(Randomization through study completion through Day 36)
- Time to hospital admission, treatment, and discharge(Randomization through study completion through Day 36)
- Number of days hospitalized(Randomization to Day 36)
- Change in clinical status as assessed using a 0-8 ordinal scale(Randomization to Day 3, Day 10, and Day 36)
- Change in RT-PCR test results(Randomization to Day 3, Day 10, and Day 36)
- Change in C-reactive protein levels(Randomization to Day 3 and Day 10)
- Cmax of STI-5656 (PK)(Randomization through Day 8)
- t½ of STI-5656 (PK)(Randomization through Day 8)
- Change in cytokine levels(Randomization to Day 3 and Day 10)
- Tmax of STI-5656 (PK)(Randomization through Day 8)