Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.

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).