EUCTR2020-001644-25-DE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
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent
- •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 7 days of randomization
- •4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen Saturation (Sp02) <94% on room air or requires supplemental oxygen
- •5. Able to swallow pills
- •6. 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 127
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. 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.
- •2. Known medical resuscitation within 14 days of randomization
- •3. Pregnant or breast feeding
- •4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
- •5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or Bilirubin = 3× upper limit of normal (ULN) and/or severe hepatic impairment detected during the screening period (per local laboratory).
- •Exception: AST and/or ALT can be up to 5 × ULN if considered due to Underlying COVID-19 disease, but cannot be associated with concurrent elevated bilirubin (up to 2 × ULN).
- •6. 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
- •7. 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)
- •8. Subjects are excluded who have already received Prior immunomodulatory/immunosuppressive treatment intended as specific treatment for COVID-19 (after randomization these agents may be
- •permitted ). Note: Steroids are permitted prior to randomization and on study
研究者
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