EUCTR2020-001644-25-FR进行中（未招募）1 期
A Phase 2 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
- 428
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 COVID-19 infection 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 3 weeks of study entry) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires 2-5 L/min of oxygen with at least one of the follow laboratory values:
- •(a) Ferritin > 300 ng/mL for men and > 150 ng/mL for women
- •(b) C-reactive protein (CRP) = 10 mg/L
- •(c) D-dimer > 1 mg/L
- •(d) Absolute lymphocyte count < 1000 cells/µL
- •4. Able to swallow capsules or receive delivery of emptied capsule via a nasogastric (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 COVID-19 infection requiring ICU admission and requiring = 6 L/min of oxygen or PaO2/FiO2 =300 mm Hg)
- •4. Able to swallow capsules or receive delivery of emptied capsule via a nasogastric (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. Are not committed to aggressive management. For example, the subject’s family or primary physician are unwilling to place the subject on mechanical ventilation or an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation, is present.
- •3. Suspected, uncontrolled active bacterial, fungal, viral, or other infection (besides COVID 19)
- •4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
- •5. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), or require home oxygen for a chronic lung disorder. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
- •6. Use of active systemic or inhaled corticosteroids. Subjects who stop active systemic or inhaled corticosteroids before the first dose of acalabrutinib will not be excluded.
- •7. Concomitant use of JAK, PI3K, or Btk (other than acalabrutinib) inhibitors with acalabrutinib. Subjects who stop JAK or PI3K inhibitors before the first dose of acalabrutinib will not be excluded. Use of other Btk inhibitors must be stopped 30 days before the first dose of acalabrutinib.
- •For Part 1:
- •1. In ICU or on invasive mechanical ventilation or ECMO machine before randomization.
- •2. Known medical resuscitation within 14 days of randomization
- •For Part 2:
- •1. Randomization to Part 1
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