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Trial record 1 of 1 for:    04346199
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Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. (CALAVI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04346199
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : May 11, 2020
Sponsor:
Collaborator:
Acerta Pharma B.V.
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Acalabrutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study will consist of two arms Arm 1 is acalabrutinib + best supportive care or Arm 2 is best supportive care alone
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 11, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
Acalabrutinib+ Best Supportive Care
Drug: Acalabrutinib
Acalabrutinib- administered orally

No Intervention: Arm 2
Best Supportive Care



Primary Outcome Measures :
  1. Subject alive and free of respiratory failure [ Time Frame: Day 14 ]

    Respiratory failure, is defined based on resource utilization of any of the following modalities:

    1. Endotracheal intubation and mechanical ventilation
    2. 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)
    3. Noninvasive positive pressure ventilation or continuous positive airway pressure
    4. Extracorporeal membrane oxygenation


Secondary Outcome Measures :
  1. Proportion of subjects alive and free of respiratory failure [ Time Frame: Day 28 ]
  2. Percent change from baseline in CRP [ Time Frame: Days 3, 5, 7, 10, 14, 28 ]
  3. Change from baseline in ferritin [ Time Frame: Days 3, 5, 7, 10, 14, 28 ]
  4. Chnage from baseline in absolute lymphocyte counts [ Time Frame: Days 3, 5, 7, 10, 14, 28 ]
  5. All cause mortality [ Time Frame: Day 90 ]
  6. Proportion of subjects alive and discharged from ICU [ Time Frame: Days 14 and 28 ]
  7. Time from randomization to first occurrence of respiratory failure or death on study due to any cause [ Time Frame: Up to 28 days after randomization ]
  8. Number of days alive and free of respiratory failure [ Time Frame: To 28 days after randomization ]
  9. Number of days with respiratory failure [ Time Frame: to 28 days after randomization ]
  10. Number of days hospitalized [ Time Frame: To 28 days after randomization ]
  11. Number of days in ICU (length of stay) [ Time Frame: To 90 days after randomization ]
  12. Number of days alive outside of hospital [ Time Frame: To 28 days after randomization ]
  13. Number of days alive outside of hospital [ Time Frame: To 90 days after randomization ]
  14. Relative change from baseline in oxygenation index (PaO2/FiO2) [ Time Frame: To Day 5 ]
  15. Occurrence of Adverse Events and Serious Adverse Events [ Time Frame: 28 days after last dose ]
    Type, frequency, severity, and relationship to study treatment of any TEAEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study treatment.

  16. Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Cmax) [ Time Frame: 28 days after last dose ]
    Peak Plasma Concentration (Cmax)

  17. Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Tmax) [ Time Frame: 28 days after last dose ]
    Time to Maximum Concentration (Tmax)

  18. Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (AUC) [ Time Frame: 28 days after last dose ]
    Area under the plasma concentration versus time curve (AUC)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. Men and women ≥18 years of age at the time of signing the informed consent form
  3. 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
  4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
  5. Able to swallow pills
  6. Willing to follow contraception guidelines

Exclusion Criteria:

  1. Respiratory failure at time of screening due to COVID-19
  2. Known medical resuscitation within 14 days of randomization
  3. Pregnant or breast feeding
  4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
  5. 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)
  6. 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
  7. 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).
  8. 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
  9. Received oral antirejection or immunomodulatory drugs (eg, anticytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346199


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator 18774004656 astrazeneca@emergingmed.com

Locations
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France
Research Site
Bobigny, France, F-93000
Research Site
Villejuif Cedex, France, 94805
Italy
Research Site
Bologna, Italy, 40138
Research Site
Firenze, Italy, 50134
Research Site
Milano, Italy, 20132
Research Site
Roma, Italy, 00133
Research Site
Roma, Italy, 00168
Spain
Research Site
Fuenlabrada, Spain, 28942
Research Site
Madrid, Spain, 28034
Research Site
Mérida, Spain, 06800
Research Site
Pozuelo de Alarcón, Spain, 28223
Sponsors and Collaborators
AstraZeneca
Acerta Pharma B.V.
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04346199    
Other Study ID Numbers: D822FC00001
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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 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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
2019 novel coronavirus disease
Acalabrutinib
Btk inhibitor