NCT04380688已完成2 期
A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Percentage of Participants Alive and Free of Respiratory Failure at Day 28
研究概览
简要总结
CALAVI US will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
- •Men and women ≥18 years of age at the time of signing the informed consent form
- •Confirmed infection with SARS-CoV-2 confirmed per World Health Organization criteria (including positive RT-PCR nucleic acid test)
- •COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
- •Able to swallow pills
- •Willing to follow contraception guidelines
排除标准
- •Respiratory failure at the time of screening due to COVID-19 pneumonia that impedes the ability to swallow pills, or in the opinion of the treating physician, the subject is likely to require mechanical ventilation within the immediate 24 hours and therefore unable to swallow pills.
- •Known medical resuscitation within 14 days of randomization
- •Pregnant or breast feeding
- •Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
- •Alanine aminotransferase (ALT), and/or aspartate aminotransferase (AST) and/or bilirubin ≥ 3x upper limit of normal (ULN) and/or severe hepatic impairment detected during the screening period (per local lab) Exception: AST and/or ALT ≤5 × ULN if considered due to underlying COVID-19 disease, but cannot be associated with concurrent elevated bilirubin (≤2 × ULN).
- •Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
- •Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 7 days before first dose of study drug) or inducer (within 14 days before first dose of study drug).
研究组 & 干预措施
Arm 1
Experimental
Acalabrutinib+ Best Supportive Care
干预措施: Acalabrutinib (Drug)
结局指标
主要结局
Percentage of Participants Alive and Free of Respiratory Failure at Day 28
时间窗: At Day 28
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by highflow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥0.5) c) Noninvasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation
Number of Participants With Adverse Events and Serious Adverse Events
时间窗: Screening to 28 (+3) days after last dose of acalabrutinib (for acalabrutinib + BSC participants) or to 38 (+3) days after randomization (for BSC alone participants)
次要结局
- Percentage of Participants Alive and Discharged From ICU(At Day 14 and at Day 28)
- Time From Randomization to First Occurrence of Respiratory Failure or Death on Study Due to Any Cause(From randomization to 28 days after randomization.)
- Number of Days With Respiratory Failure(From randomization to 28 days after randomization.)
- Number of Days Hospitalized(From randomization to 28 days after randomization.)
- Percent Change From Baseline in Absolute Lymphocyte Count(Days 3, 5, 7, 10, 14, 28)
- Number of Days Alive and Free of Respiratory Failure(From randomization to 28 days after randomization.)
- Number of Days Alive Outside of Hospital(From randomization to 90 days after randomization.)
- Pharmacokinetics of Acalabrutinib(Day 3 and Day 7)
- Percentage of Participants Alive and Free of Respiratory Failure at Day 14(At Day 14)
- Percent Change From Baseline in C-reactive Protein.(Days 3, 5, 7, 10, 14, 28)
- Percent Change From Baseline in Ferritin(Days 3, 5, 7, 10, 14, 28)
- Percent Change From Baseline in Oxygenation Index(Days 3, 5, 7, 10, 14, 28)
- Overall Survival(From randomization until 90 days after randomization.)
- Number of Days in ICU(From randomization to 90 days after randomization.)
- Time From Randomization to Clinical Improvement of at Least 2 Points on a 9-point Category Ordinal Scale(From randomization to 28 days after randomization.)
- Pharmacokinetics of ACP-5862(Day 3 and Day 7)
研究者
研究点 (1)
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