Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. (CALAVI US)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04380688 |
Recruitment Status :
Completed
First Posted : May 8, 2020
Results First Posted : September 13, 2021
Last Update Posted : September 13, 2021
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Sponsor:
AstraZeneca
Collaborator:
Acerta Pharma BV
Information provided by (Responsible Party):
AstraZeneca
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
COVID-19 |
Intervention |
Drug: Acalabrutinib |
Enrollment | 62 |
Participant Flow
Recruitment Details | All participants were recruited from the United States and had COVID-19 pneumonia (documented radiographically) requiring hospitalization. The first participant was randomized on 13 June 2020 and the last participant was randomized on 20 August 2020. |
Pre-assignment Details | Screening assessments were performed within the 3 days prior to randomization. Of 70 screened participants, 62 were enrolled. Of the 8 participants that were not enrolled, 7 were screen failures (did not meet eligibility criteria) and 1 withdrew consent. |
Arm/Group Title | Acalabrutinib + BSC | BSC Alone |
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Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines. | Participants received best supportive care per the discretion of the Investigator and institutional guidelines. |
Period Title: Overall Study | ||
Started | 31 | 31 |
Completed | 24 | 22 |
Not Completed | 7 | 9 |
Reason Not Completed | ||
Death | 2 | 2 |
Lost to Follow-up | 2 | 4 |
Withdrawal by Subject | 3 | 3 |
Baseline Characteristics
Arm/Group Title | Acalabrutinib + BSC | BSC Alone | Total | |
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Participants received acalabrutinib 100mg tablet orally twice daily for 10 days, plus best supportive care per the discretion of the Investigator and institutional guidelines. | Participants received best supportive care per the discretion of the Investigator and institutional guidelines. | Total of all reporting groups | |
Overall Number of Baseline Participants | 31 | 31 | 62 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 31 participants | 31 participants | 62 participants | |
52.5 (13.3) | 51.9 (14.3) | 52.2 (13.7) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants | 31 participants | 62 participants |
< 65 years | 26 | 25 | 51 | |
>= 65 years | 5 | 6 | 11 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 31 participants | 31 participants | 62 participants | |
Female |
13 41.9%
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9 29.0%
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22 35.5%
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Male |
18 58.1%
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22 71.0%
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40 64.5%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants | 31 participants | 62 participants |
HISPANIC OR LATINO | 15 | 13 | 28 | |
NOT HISPANIC OR LATINO | 16 | 17 | 33 | |
NOT REPORTED | 0 | 0 | 0 | |
MISSING | 0 | 1 | 1 | |
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 31 participants | 31 participants | 62 participants |
WHITE | 18 | 20 | 38 | |
BLACK OR AFRICAN AMERICAN | 7 | 5 | 12 | |
AMERICAN INDIAN OR ALASKA NATIVE | 1 | 0 | 1 | |
ASIAN | 0 | 0 | 0 | |
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER | 0 | 0 | 0 | |
OTHER | 3 | 2 | 5 | |
NOT REPORTED | 2 | 3 | 5 | |
MISSING | 0 | 1 | 1 |
Outcome Measures
Adverse Events
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.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
PI shall provide copies of any materials relating to the Study, or the Developed Technologies that either intends to publish or make any presentations relating to, at least 30 days in advance of publication, submission or presentation.
PI shall not include in or shall remove from any proposed publication of any Confidential Information, errors or inaccuracies; and shall withhold publication, submission for publication or presentation for 90 days from the date the Company receives the material.
Results Point of Contact
Name/Title: | Study Information Center |
Organization: | AstraZeneca |
Phone: | 1-877-240-9479 |
EMail: | information.center@astrazeneca.com |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT04380688 |
Other Study ID Numbers: |
D822FC00003 |
First Submitted: | May 7, 2020 |
First Posted: | May 8, 2020 |
Results First Submitted: | August 19, 2021 |
Results First Posted: | September 13, 2021 |
Last Update Posted: | September 13, 2021 |