Official Title
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
Brief Summary

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

Completed
COVID-19

Drug: Acalabrutinib

Acalabrutinib administered orally

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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 130 Years
Countries
United States
Locations

Research Site
Anniston, Alabama, United States

Research Site
Mobile, Alabama, United States

Research Site
Escondido, California, United States

Research Site
Fullerton, California, United States

Research Site
Glendale, California, United States

Research Site
Newport Beach, California, United States

Research Site
New Haven, Connecticut, United States

Research Site
Washington, District of Columbia, United States

Research Site
Fort Lauderdale, Florida, United States

Research Site
Jacksonville, Florida, United States

Research Site
Jacksonville, Florida, United States

Research Site
Loxahatchee Groves, Florida, United States

Research Site
Fort Wayne, Indiana, United States

Research Site
Louisville, Kentucky, United States

Research Site
Annapolis, Maryland, United States

Research Site
Baltimore, Maryland, United States

Research Site
Bethesda, Maryland, United States

Research Site
Bethesda, Maryland, United States

Research Site
Silver Spring, Maryland, United States

Research Site
Hackensack, New Jersey, United States

Research Site
Albany, New York, United States

Research Site
Bronx, New York, United States

Research Site
Buffalo, New York, United States

Research Site
New York, New York, United States

Research Site
Philadelphia, Pennsylvania, United States

Research Site
Nashville, Tennessee, United States

Research Site
Houston, Texas, United States

Research Site
Houston, Texas, United States

Research Site
Tyler, Texas, United States

Research Site
Richmond, Virginia, United States

Research Site
Renton, Washington, United States

Acerta Pharma BV
NCT Number
Keywords
2019 novel coronavirus disease
Acalabrutinib
Btk inhibitor
MeSH Terms
COVID-19
Acalabrutinib