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Trial record 1 of 6 for:    Acalabrutinib | Covid19
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Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19

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: NCT04497948
Recruitment Status : Terminated (

Data from the CALAVI Phase II trials for Acalabrutinib in patients hospitalized with COVID-19 did not meet their primary efficacy endpoints.

Based on this higher management made the decision to prematurely terminate the D822FC00005 PK study.

)
First Posted : August 4, 2020
Results First Posted : November 5, 2021
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition COVID-19
Intervention Drug: Acalabrutinib
Enrollment 9
Recruitment Details Approximately 20 participants were planned to be enrolled to have at least 16 evaluable participants.
Pre-assignment Details The study enrollment was terminated early due to the termination of the Calquence COVID-19 Clinical development program (LSPC Nov 2020)
Arm/Group Title Acalabrutinib + BSC + PPI
Hide Arm/Group Description Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
Period Title: Overall Study
Started 9
Completed 7
Not Completed 2
Reason Not Completed
Death             2
Arm/Group Title Acalabrutinib + BSC + PPI
Hide Arm/Group Description Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants
61.3  (10.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
< 65 years 4
>= 65 years 5
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Hispanic or Latino
7
  77.8%
Not Hispanic or Latino
2
  22.2%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
WHITE 7
BLACK OR AFRICAN AMERICAN 2
AMERICAN INDIAN OR ALASKA NATIVE 0
ASIAN 0
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER 0
OTHER 0
NOT REPORTED 0
1.Primary Outcome
Title Area Under the Concentration-time Curve From 0 to 12 Hours (AUC12h) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2 (Day 2), and Visit 3 (Day 5)
Hide Description To summarize the PK parameter AUC12h of Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC + PPI
Time Frame pre-dose and 0.5, 1, 2, 4, 6, and 12 hours in visit 1 on Day 1, visit 2 on Day 2 and visit 3 on Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each Acalabrutinib and ACP-5862 analytes.
Arm/Group Title Acalabrutinib + BSC + PPI, Visit 1 on Day 1 Acalabrutinib + BSC + PPI, Visit 2 on Day 2 Acalabrutinib + BSC + PPI, Visit 3 on Day 5
Hide Arm/Group Description:
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 1 on Day 1.
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 2 on Day 2.
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 3 on Day 5.
Overall Number of Participants Analyzed 9 9 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h·ng/mL
Acalabrutinib Number Analyzed 9 participants 9 participants 7 participants
524.7
(86.5%)
496.5
(58.0%)
201.1
(95.3%)
ACP-5862 Number Analyzed 8 participants 9 participants 7 participants
832.8
(29.3%)
1228.0
(35.1%)
867.1
(43.1%)
2.Primary Outcome
Title Area Under the Concentration-time Curve From 0 to Time to Last Quantifiable Concentration (AUClast) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2 (Day 2), and Visit 3 (Day 5)
Hide Description To summarize the PK parameter AUClast for Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC +PPI
Time Frame pre-dose and 0.5, 1, 2, 4, 6, and 12 hours in visit 1 on Day 1, visit 2 on Day 2 and visit 3 on Day5
Hide Outcome Measure Data
Hide Analysis Population Description
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each Acalabrutinib and ACP-5862 analytes.
Arm/Group Title Acalabrutinib + BSC + PPI, Visit 1 on Day 1 Acalabrutinib + BSC + PPI, Visit 2 on Day 2 Acalabrutinib + BSC + PPI, Visit 3 on Day 5
Hide Arm/Group Description:
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 2 on Day 2.
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment on visit 3 on Day 5.
Overall Number of Participants Analyzed 9 9 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h·ng/mL
Acalabrutinib
490.1
(64.8%)
493.7
(58.4%)
193.7
(96.6%)
ACP-5862
731.0
(38.4%)
1228.0
(35.1%)
827.9
(46.2%)
3.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2(Day2) and Visit 3 (Day 5)
Hide Description To summarize the PK parameter Cmax of Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC +PPI
Time Frame pre-dose and 0.5, 1, 2, 4, 6, and 12 hours in visit 1(Day 1), visit 2(Day 2) and visit 3(Day 5)
Hide Outcome Measure Data
Hide Analysis Population Description
Here, number analyzed in each row signifies only the participants with available data that were analyzed for each Acalabrutinib and ACP-5862 analytes.
Arm/Group Title Acalabrutinib + BSC + PPI, Visit 1 on Day 1 Acalabrutinib + BSC + PPI, Visit 2 on Day 2 Acalabrutinib + BSC + PPI, Visit 3 on Day 5
Hide Arm/Group Description:
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 1 on Day 1.
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 2 on Day 2.
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 3 on Day 5.
Overall Number of Participants Analyzed 9 9 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Acalabrutinib
297.0
(56.7%)
307.9
(51.3%)
167.1
(88.7%)
ACP-5862
213.1
(62.9%)
316.9
(38.5%)
324.2
(47.6%)
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acalabrutinib + BSC + PPI
Hide Arm/Group Description Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
All-Cause Mortality
Acalabrutinib + BSC + PPI
Affected / at Risk (%)
Total   2/9 (22.22%)    
Hide Serious Adverse Events
Acalabrutinib + BSC + PPI
Affected / at Risk (%) # Events
Total   5/9 (55.56%)    
Infections and infestations   
Device related infection  1  1/9 (11.11%)  1
Pneumonia  1  1/9 (11.11%)  1
Pneumonia bacterial  1  2/9 (22.22%)  2
Investigations   
Transaminases increased  1  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/9 (11.11%)  1
Vascular disorders   
Hypotension  1  1/9 (11.11%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acalabrutinib + BSC + PPI
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  5/9 (55.56%)  6
Lymphopenia  1  2/9 (22.22%)  2
Thrombocytopenia  1  1/9 (11.11%)  3
Gastrointestinal disorders   
Abdominal distension  1  2/9 (22.22%)  2
Constipation  1  1/9 (11.11%)  1
Diarrhoea  1  1/9 (11.11%)  1
Vomiting  1  1/9 (11.11%)  1
Infections and infestations   
Fungal infection  1  1/9 (11.11%)  1
Infection  1  1/9 (11.11%)  1
Klebsiella infection  1  1/9 (11.11%)  1
Lower respiratory tract infection bacterial  1  1/9 (11.11%)  1
Pneumonia  1  2/9 (22.22%)  2
Pneumonia bacterial  1  2/9 (22.22%)  2
Urinary tract infection  1  1/9 (11.11%)  1
Investigations   
Alanine aminotransferase increased  1  2/9 (22.22%)  2
Aspartate aminotransferase increased  1  2/9 (22.22%)  3
Hepatic enzyme increased  1  1/9 (11.11%)  1
Metabolism and nutrition disorders   
Hyperglycaemia  1  1/9 (11.11%)  1
Hypernatraemia  1  2/9 (22.22%)  3
Hypophosphataemia  1  2/9 (22.22%)  2
Type 2 diabetes mellitus  1  1/9 (11.11%)  1
Nervous system disorders   
Peripheral motor neuropathy  1  2/9 (22.22%)  3
Polyneuropathy  1  1/9 (11.11%)  1
Psychiatric disorders   
Anxiety  1  1/9 (11.11%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/9 (11.11%)  1
Renal impairment  1  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Haemoptysis  1  1/9 (11.11%)  1
Laryngospasm  1  1/9 (11.11%)  1
Organising pneumonia  1  1/9 (11.11%)  1
Pulmonary embolism  1  1/9 (11.11%)  1
Skin and subcutaneous tissue disorders   
Dermatitis  1  1/9 (11.11%)  1
Vascular disorders   
Haematoma  1  1/9 (11.11%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Study Information Center
Organization: AstraZeneca
Phone: 1-877-240-9479
EMail: information.center@astrazeneca.com
Layout table for additonal information
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT04497948    
Other Study ID Numbers: D822FC00005
First Submitted: June 16, 2020
First Posted: August 4, 2020
Results First Submitted: October 29, 2021
Results First Posted: November 5, 2021
Last Update Posted: November 17, 2021