Completed
CALAVIA 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
What is being tested
Acalabrutinib
Drug
Who is being recruted
COVID-19+9
+ Coronaviridae Infections
+ Infections
From 18 to 130 Years
+15 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: June 2020
Summary
Principal SponsorAstraZeneca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 12, 2020
Actual date on which the first participant was enrolled.CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
Official TitleA 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
Principal SponsorAstraZeneca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
177 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 130 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
COVID-19Coronaviridae InfectionsInfectionsLung DiseasesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCoronavirus InfectionsNidovirales Infections
Criteria
6 inclusion criteria required to participate
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
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9 exclusion criteria prevent from participating
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)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalAcalabrutinib+ Best Supportive Care
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 50 locations
Suspended
Suspended
Research Site
Ciudad de Buenos Aires, ArgentinaSuspended
Research Site
Monte Grande, ArgentinaSuspended
Research Site
Ramos Mejía, ArgentinaCompleted50 Study Centers