EUCTR2020-001644-25-ES进行中（未招募）1 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 - CALAVI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 177
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For Part 1 (Randomized cohort):
- •1.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)
- •2.Men and women =18 years of age at the time of signing the informed consent form
- •3.Confirmed infection with SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization
- •4.Able to swallow capsules or receive delivery of emptied capsule via a NG or an enteral feeding tube
- •5.Willing to follow contraception guidelines
- •For Part 2 Intensive Care Unit (ICU Cohort):
- •1.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)
- •2.Men and women =18 years of age at the time of signing the informed consent form
- •3.Confirmed infection with SARS-CoV-2 per WHO criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of randomization
- •4.Able to swallow capsules or receive delivery of emptied capsule via a NG or an enteral feeding tube
- •5.Willing to follow contraception guidelines
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 128
排除标准
- •For Part 1 and Part 2 (All Subjects):
- •1. Pregnant or breast feeding
- •2. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
- •3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
- •4. 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 on study.
- •For Part 1:
- •1.Respiratory failure before randomization
- •2.Known medical resuscitation within 14 days of randomization
- •For Part 2:
- •1.Randomization to Part 1
研究者
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