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Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. (CALAVI US)

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: NCT04380688
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
Acerta Pharma B.V.
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
CALAVI US 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 : 60 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
Actual Study Start Date : June 13, 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. Occurrence of Adverse Events and Serious Adverse Events [ Time Frame: Day 14 ]
    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.

  2. Subject alive and free of respiratory failure [ Time Frame: Day 28 ]

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

    1. Endotracheal intubation and mechanical ventilation
    2. 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)
    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. Change 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: Up to 28 days after randomization ]
  9. Number of days with respiratory failure [ Time Frame: Up to 28 days after randomization ]
  10. Number of days hospitalized [ Time Frame: Up to 28 days after randomization ]
  11. Number of days in ICU (length of stay) [ Time Frame: Up to 90 days after randomization ]
  12. Number of days alive outside of hospital [ Time Frame: Up to 28 days after randomization ]
  13. Number of days alive outside of hospital [ Time Frame: Up to 90 days after randomization ]
  14. Relative change from baseline in oxygenation index (SpO2/FiO2) [ Time Frame: Days 3, 5, 7, and 10 ]
  15. Time to clinical improvement of at least 2 points (from randomization) on a 9-point category ordinal scale [ Time Frame: Up to 28 days after randomization ]
  16. Time to SpO2 > 94% on room air [ Time Frame: Up to 28 days after randomization ]
  17. Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 [ Time Frame: Days 3 and 7 ]
    Plasma concentrations of acalabrutinib and ACP-5862



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 criteria (including positive RT-PCR nucleic acid test)
  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 Exception: Subjects are eligible if utilizing oxygen delivered by high-flow nasal cannula at flow rates <30 L/min and fraction of delivered oxygen <0.6, and in the opinion of the treating physician are unlikely to require mechanical ventilation within the immediate 24 hours
  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 during the screening period (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 7 days before first dose of study drug) or inducer (within 14 days before first dose of study drug).

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): NCT04380688


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

Locations
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United States, California
Research Site Not yet recruiting
Newport Beach, California, United States, 92663
United States, District of Columbia
Research Site Not yet recruiting
Washington, District of Columbia, United States, 20010
United States, Kentucky
Research Site Not yet recruiting
Louisville, Kentucky, United States, 40207
United States, Maryland
Research Site Not yet recruiting
Baltimore, Maryland, United States, 21287
Research Site Not yet recruiting
Bethesda, Maryland, United States, 20889
Research Site Not yet recruiting
Bethesda, Maryland, United States, 20892-1374
United States, New Jersey
Research Site Not yet recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Research Site Not yet recruiting
Albany, New York, United States, 12206
Research Site Not yet recruiting
Buffalo, New York, United States, 14263
Research Site Not yet recruiting
New York, New York, United States, 10021
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
AstraZeneca
Acerta Pharma B.V.
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04380688    
Other Study ID Numbers: D822FC00003
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 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 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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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