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 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 (WHO)
criteria (including positive RT-PCR nucleic acid test of any specimen [eg,
respiratory, blood, urine, stool, or other bodily fluid]) within 4 days of
randomization

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 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 130 Years
Countries
Argentina
Brazil
Chile
France
Germany
India
Italy
Japan
Mexico
Peru
Poland
Russian Federation
South Africa
Turkey
Locations

Research Site
Ciudad de Buenos Aires, Argentina

Research Site
Ciudad de Buenos Aires, Argentina

Research Site
Monte Grande, Argentina

Research Site
Ramos Mejía, Argentina

Research Site
Botucatu, Brazil

Research Site
Brasillia, Brazil

Research Site
Florianópolis, Brazil

Research Site
Porto Alegre, Brazil

Research Site
Porto Alegre, Brazil

Research Site
Ribeirão Preto, Brazil

Research Site
Salvador, Brazil

Research Site
Sao Bernardo do Campo, Brazil

Research Site
Sao Paulo, Brazil

Research Site
Sao Paulo, Brazil

Research Site
São Paulo, Brazil

Research Site
Curico, Chile

Research Site
Santiago, Chile

Research Site
Talca, Chile

Research Site
Villejuif Cedex, France

Research Site
Frankfurt, Germany

Research Site
Gauting, Germany

Research Site
Köln, Germany

Research Site
Bangalore, India

Research Site
New Delhi, India

Research Site
Milano, Italy

Research Site
Roma, Italy

Research Site
Shinjuku-ku, Japan

Research Site
D.F, Mexico

Research Site
Monterrey, Mexico

Research Site
México, Mexico

Research Site
Lima, Peru

Research Site
Lima, Peru

Research Site
Lima, Peru

Research Site
Warszawa, Poland

Research Site
Warszawa, Poland

Research Site
Moscow, Russian Federation

Research Site
Moscow, Russian Federation

Research Site
Moscow, Russian Federation

Research Site
Moscow, Russian Federation

Research Site
Murmansk, Russian Federation

Research Site
Cape Town, South Africa

Research Site
George, South Africa

Research Site
Johannesburg, South Africa

Research Site
Johannesburg, South Africa

Research Site
Pretoria, South Africa

Research Site
Ankara, Turkey

Research Site
Bakirkoy, Turkey

Research Site
Istanbul, Turkey

Research Site
Istanbul, Turkey

Research Site
Umraniye, Turkey

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