Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Acalabrutinib
Intervention description: Acalabrutinib administered orally
Intervention MeSH terms: Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study will consist of two arms Arm 1 is acalabrutinib + best supportive care or Arm 2 is best supportive care alone
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: 2019 novel coronavirus disease; Acalabrutinib; Btk inhibitor

Summary:

      CALAVI US will investigate the safety, efficacy and pharmacokinetics of acalabrutinib
      together with Best Supportive Care in the treatment of COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          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 criteria
             (including positive RT-PCR nucleic acid test)

          4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen
             saturation <94% on room air or requires supplemental oxygen

          5. Able to swallow pills

          6. Willing to follow contraception guidelines

        Exclusion Criteria:

          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), 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).

          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).