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

NCT04380688 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: D822FC00003
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

COVID-19

Keywords

2019 novel coronavirus disease; Acalabrutinib; Btk inhibitor

Outcome Measures

Primary Outcomes (2)

• 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

  Respiratory failure, is defined based on resource utilization of any of the following modalities: a) Endotracheal intubation and mechanical ventilation b) Oxygen delivered by highflow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥0.5) c) Noninvasive positive pressure ventilation or continuous positive airway pressure d) Extracorporeal membrane oxygenation

  At Day 28

Secondary Outcomes (17)

• Percentage of Participants Alive and Free of Respiratory Failure at Day 14

  At Day 14

• 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

• Overall Survival

  From randomization until 90 days after randomization.

Study Arms (2)

Arm 1

EXPERIMENTAL

Acalabrutinib+ Best Supportive Care

Drug: Acalabrutinib

Arm 2

NO INTERVENTION

Best Supportive Care

Interventions

Acalabrutinib DRUG

Acalabrutinib administered orally

Arm 1

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• AstraZeneca: lead
• Acerta Pharma BV: collaborator

Study Sites (31)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Mobile, Alabama, 36604, United States

Location

Research Site

Escondido, California, 92029, United States

Location

Research Site

Fullerton, California, 92835, United States

Location

Research Site

Glendale, California, 91206, United States

Location

Research Site

Newport Beach, California, 92663, United States

Location

Research Site

New Haven, Connecticut, 06519, United States

Location

Research Site

Washington D.C., District of Columbia, 20010, United States

Location

Research Site

Fort Lauderdale, Florida, 33308, United States

Location

Research Site

Jacksonville, Florida, 32207, United States

Location

Research Site

Jacksonville, Florida, 32209, United States

Location

Research Site

Loxahatchee Groves, Florida, 33470, United States

Location

Research Site

Fort Wayne, Indiana, 46804, United States

Location

Research Site

Louisville, Kentucky, 40207, United States

Location

Research Site

Annapolis, Maryland, 21401, United States

Location

Research Site

Baltimore, Maryland, 21287, United States

Location

Research Site

Bethesda, Maryland, 20889, United States

Location

Research Site

Bethesda, Maryland, 20892-1374, United States

Location

Research Site

Silver Spring, Maryland, 20910, United States

Location

Research Site

Hackensack, New Jersey, 07601, United States

Location

Research Site

Albany, New York, 12208, United States

Location

Research Site

Buffalo, New York, 14263, United States

Location

Research Site

New York, New York, 10029, United States

Location

Research Site

The Bronx, New York, 10467, United States

Location

Research Site

Philadelphia, Pennsylvania, 19140, United States

Location

Research Site

Nashville, Tennessee, 38120, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Houston, Texas, 77090, United States

Location

Research Site

Tyler, Texas, 75701, United States

Location

Research Site

Richmond, Virginia, 23298, United States

Location

Research Site

Renton, Washington, 98055, United States

Location

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: 40461100 DERIVED

Related Links

• Redacted CSP
• Related Info
• CSR Synopsis

MeSH Terms

Conditions

COVID-19

Interventions

acalabrutinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

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

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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

Model Details: Study will consist of two arms Arm 1 is acalabrutinib + best supportive care or Arm 2 is best supportive care alone

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 8, 2020
• Study Start: June 13, 2020
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: September 13, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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 deidentified 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.

Locations

US (31)