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

Completed · Phase 2

Conditions studied: COVID-19

In brief

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

Key facts

Study ID

NCT04380688

Run by

AstraZeneca

People needed

62

Starts

2020-06-13

Expected to finish

2020-11-16

Last updated by the study team

2021-09-13

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 criteria (including positive RT-PCR nucleic acid test)
• 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

You may not qualify if…

• 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.
• 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), 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).
• 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 7 days before first dose of study drug) or inducer (within 14 days before first dose of study drug).

Where it is running

• 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 D.C., 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 — Buffalo, New York, United States
• Research Site — New York, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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