Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.
CALAVI
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
1 other identifier
interventional
177
14 countries
50
Brief Summary
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 covid19
Started Jun 2020
Shorter than P25 for phase_2 covid19
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedStudy Start
First participant enrolled
June 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 17, 2020
CompletedResults Posted
Study results publicly available
September 13, 2021
CompletedSeptember 17, 2021
September 1, 2021
5 months
April 9, 2020
September 8, 2021
September 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Alive and Free of Respiratory Failure at Day 14
Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥0.5) c) Non-invasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation
At Day 14
Secondary Outcomes (18)
Number of Participants With Adverse Events and Serious Adverse Events
Screening to 28 (+3) days after last dose of acalabrutinib (for acalabrutinib + BSC participants) or to 38 (+3) days after randomization (for BSC alone participants)
Percentage of Participants Alive and Free of Respiratory Failure at Day 28
At Day 28
Percent Change From Baseline in C-reactive Protein.
Days 3, 5, 7, 10, 14, 28
Percent Change From Baseline in Ferritin
Days 3, 5, 7, 10, 14, 28
Percent Change From Baseline in Absolute Lymphocyte Count
Days 3, 5, 7, 10, 14, 28
- +13 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALAcalabrutinib+ Best Supportive Care
Arm 2
NO INTERVENTIONBest Supportive Care
Interventions
Eligibility Criteria
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 (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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Acerta Pharma BVcollaborator
Study Sites (50)
Research Site
Ciudad de Buenos Aires, 1221, Argentina
Research Site
Ciudad de Buenos Aires, C1180AAX, Argentina
Research Site
Monte Grande, B1842, Argentina
Research Site
Ramos Mejía, B1704, Argentina
Research Site
Botucatu, 18618-687, Brazil
Research Site
Brasillia, 72145-450, Brazil
Research Site
Florianópolis, 88036-800, Brazil
Research Site
Porto Alegre, 90035-903, Brazil
Research Site
Porto Alegre, 91350-200, Brazil
Research Site
Ribeirão Preto, 14051-140, Brazil
Research Site
Salvador, 40110-060, Brazil
Research Site
São Bernardo do Campo, 09715090, Brazil
Research Site
São Paulo, 01308-050, Brazil
Research Site
São Paulo, 01327-001, Brazil
Research Site
São Paulo, 04004-030, Brazil
Research Site
Curicó, 3341643, Chile
Research Site
Santiago, 7500692, Chile
Research Site
Talca, 3460001, Chile
Research Site
Villejuif, 94805, France
Research Site
Cologne, 50937, Germany
Research Site
Frankfurt, 60590, Germany
Research Site
Gauting, 82131, Germany
Research Site
Bangalore, 560002, India
Research Site
New Delhi, 110017, India
Research Site
Milan, 20132, Italy
Research Site
Roma, 00168, Italy
Research Site
Shinjuku-ku, 162-8655, Japan
Research Site
D.F, 14050, Mexico
Research Site
México, 03103, Mexico
Research Site
Monterrey, 64461, Mexico
Research Site
Lima, 15324, Peru
Research Site
Lima, LIMA 11, Peru
Research Site
Lima, LIMA 1, Peru
Research Site
Warsaw, 02-507, Poland
Research Site
Warsaw, 04-141, Poland
Research Site
Moscow, 111539, Russia
Research Site
Moscow, 119992, Russia
Research Site
Moscow, 123182, Russia
Research Site
Moscow, 143442, Russia
Research Site
Murmansk, 183047, Russia
Research Site
Cape Town, 7500, South Africa
Research Site
George, 6529, South Africa
Research Site
Johannesburg, 1827, South Africa
Research Site
Johannesburg, 2193, South Africa
Research Site
Pretoria, 0157, South Africa
Research Site
Ankara, 06800, Turkey (Türkiye)
Research Site
Bakırköy, 34147, Turkey (Türkiye)
Research Site
Istanbul, 34214, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Umraniye, 34760, Turkey (Türkiye)
Related Publications (1)
Scheinberg P, Khoshnevis MR, Robinson PA, Guerreros A, Sato VAH, Fonseca BAL, Prozesky HW, Romero JOC, Fogliatto L, Meisenberg BR, Park DJ, Gupta A, Patel P, Townsley DM, Zheng L, Munugalavadla V. Efficacy and safety of acalabrutinib with best supportive care versus best supportive care in patients with COVID-19 requiring hospitalization. Immunohorizons. 2025 May 30;9(7):vlaf023. doi: 10.1093/immhor/vlaf023.
PMID: 40461100DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Improvements in BSC (use of corticosteroids and antivirals) have led to a substantial reduction in mortality and morbidity in patients hospitalized with COVID-19, which, in turn, minimizes the impact that additional treatment regimens can have on patient prognosis and recovery. In addition, variability in patient population and the performance of BSC across the globe poses challenges to demonstrate benefit.
Results Point of Contact
- Title
- Study Information Center
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2020
First Posted
April 15, 2020
Study Start
June 12, 2020
Primary Completion
November 17, 2020
Study Completion
November 17, 2020
Last Updated
September 17, 2021
Results First Posted
September 13, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.