Status:
COMPLETED
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Acerta Pharma BV
Conditions:
COVID-19
Eligibility:
All Genders
18-130 years
Phase:
PHASE2
Brief Summary
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
Eligibility Criteria
Inclusion
- 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)
- Men and women ≥18 years of age at the time of signing the informed consent form
- 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
- COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation \<94% on room air or requires supplemental oxygen
- Able to swallow pills
- Willing to follow contraception guidelines
Exclusion
- Respiratory failure at time of screening due to COVID-19
- Known medical resuscitation within 14 days of randomization
- Pregnant or breast feeding
- Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
- 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)
- 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
- 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).
- 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
- Received oral antirejection or immunomodulatory drugs (eg, anticytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
Key Trial Info
Start Date :
June 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2020
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT04346199
Start Date
June 12 2020
End Date
November 17 2020
Last Update
September 17 2021
Active Locations (50)
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1
Research Site
Ciudad de Buenos Aires, Argentina, 1221
2
Research Site
Ciudad de Buenos Aires, Argentina, C1180AAX
3
Research Site
Monte Grande, Argentina, B1842
4
Research Site
Ramos Mejía, Argentina, B1704