Acalabrutinib study with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19. - CALAVI

Exclusion Criteria

• 1. Respiratory failure at time of screening due to COVID-19
• 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 ≥ 3x upper limit of normal (ULN) and/or severe hepatic
• impairment detected within 24 hours at screening (per local lab)
• 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
• 14 days before first dose of study drug) or inducer (within 7 days before
• first dose of study drug).
• 8. Requires treatment with proton-pump inhibitors (PPIs; eg,
• omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole,
• or pantoprazole). Subjects receiving PPIs who switch to H2-receptor
• antagonists or antacids are eligible for enrollment in this study
• 9. Received oral antirejection or immunomodulatory drugs (eg, anticytokines,
• Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days
• before randomization on study