Trial Outcomes & Findings for Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19 (NCT NCT04497948)
NCT ID: NCT04497948
Last Updated: 2021-11-17
Results Overview
To summarize the PK parameter AUC12h of Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC + PPI
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
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
Results posted on
2021-11-17
Participant Flow
Approximately 20 participants were planned to be enrolled to have at least 16 evaluable participants.
The study enrollment was terminated early due to the termination of the Calquence COVID-19 Clinical development program (LSPC Nov 2020)
Participant milestones
| Measure |
Acalabrutinib + BSC + PPI
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Acalabrutinib + BSC + PPI
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
Baseline characteristics by cohort
| Measure |
Acalabrutinib + BSC + PPI
n=9 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
|
|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
|
Age, Customized
< 65 years
|
4 Participants
n=99 Participants
|
|
Age, Customized
>= 65 years
|
5 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
AMERICAN INDIAN OR ALASKA NATIVE
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
OTHER
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
NOT REPORTED
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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 5Population: Here, number analyzed in each row signifies only the participants with available data that were analyzed for each Acalabrutinib and ACP-5862 analytes.
To summarize the PK parameter AUC12h of Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC + PPI
Outcome measures
| Measure |
Acalabrutinib + BSC + PPI, Visit 1 on Day 1
n=9 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 1 on Day 1.
|
Acalabrutinib + BSC + PPI, Visit 2 on Day 2
n=9 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 2 on Day 2.
|
Acalabrutinib + BSC + PPI, Visit 3 on Day 5
n=7 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 3 on Day 5.
|
|---|---|---|---|
|
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)
Acalabrutinib
|
524.7 h·ng/mL
Geometric Coefficient of Variation 86.5
|
496.5 h·ng/mL
Geometric Coefficient of Variation 58.0
|
201.1 h·ng/mL
Geometric Coefficient of Variation 95.3
|
|
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)
ACP-5862
|
832.8 h·ng/mL
Geometric Coefficient of Variation 29.3
|
1228.0 h·ng/mL
Geometric Coefficient of Variation 35.1
|
867.1 h·ng/mL
Geometric Coefficient of Variation 43.1
|
PRIMARY outcome
Timeframe: 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 Day5Population: Here, number analyzed in each row signifies only the participants with available data that were analyzed for each Acalabrutinib and ACP-5862 analytes.
To summarize the PK parameter AUClast for Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC +PPI
Outcome measures
| Measure |
Acalabrutinib + BSC + PPI, Visit 1 on Day 1
n=9 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 1 on Day 1.
|
Acalabrutinib + BSC + PPI, Visit 2 on Day 2
n=9 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 2 on Day 2.
|
Acalabrutinib + BSC + PPI, Visit 3 on Day 5
n=7 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 3 on Day 5.
|
|---|---|---|---|
|
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)
Acalabrutinib
|
490.1 h·ng/mL
Geometric Coefficient of Variation 64.8
|
493.7 h·ng/mL
Geometric Coefficient of Variation 58.4
|
193.7 h·ng/mL
Geometric Coefficient of Variation 96.6
|
|
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)
ACP-5862
|
731.0 h·ng/mL
Geometric Coefficient of Variation 38.4
|
1228.0 h·ng/mL
Geometric Coefficient of Variation 35.1
|
827.9 h·ng/mL
Geometric Coefficient of Variation 46.2
|
PRIMARY outcome
Timeframe: 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)Population: Here, number analyzed in each row signifies only the participants with available data that were analyzed for each Acalabrutinib and ACP-5862 analytes.
To summarize the PK parameter Cmax of Acalabrutinib/ACP-5862 in single arm, Acalabrutinib + BSC +PPI
Outcome measures
| Measure |
Acalabrutinib + BSC + PPI, Visit 1 on Day 1
n=9 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 1 on Day 1.
|
Acalabrutinib + BSC + PPI, Visit 2 on Day 2
n=9 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 2 on Day 2.
|
Acalabrutinib + BSC + PPI, Visit 3 on Day 5
n=7 Participants
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment in visit 3 on Day 5.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2(Day2) and Visit 3 (Day 5)
Acalabrutinib
|
297.0 ng/mL
Geometric Coefficient of Variation 56.7
|
307.9 ng/mL
Geometric Coefficient of Variation 51.3
|
167.1 ng/mL
Geometric Coefficient of Variation 88.7
|
|
Maximum Observed Plasma Concentration (Cmax) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2(Day2) and Visit 3 (Day 5)
ACP-5862
|
213.1 ng/mL
Geometric Coefficient of Variation 62.9
|
316.9 ng/mL
Geometric Coefficient of Variation 38.5
|
324.2 ng/mL
Geometric Coefficient of Variation 47.6
|
Adverse Events
Acalabrutinib + BSC + PPI
Serious events: 5 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Acalabrutinib + BSC + PPI
n=9 participants at risk
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
|
|---|---|
|
Infections and infestations
Device related infection
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Infections and infestations
Pneumonia
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Infections and infestations
Pneumonia bacterial
|
22.2%
2/9 • Number of events 2 • 2 months
|
|
Investigations
Transaminases increased
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • 2 months
|
Other adverse events
| Measure |
Acalabrutinib + BSC + PPI
n=9 participants at risk
Acalabrutinib with Best Supportive Care also with the Proton-Pump Inhibitor(PPI) treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
55.6%
5/9 • Number of events 6 • 2 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
22.2%
2/9 • Number of events 2 • 2 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • Number of events 3 • 2 months
|
|
Gastrointestinal disorders
Abdominal distension
|
22.2%
2/9 • Number of events 2 • 2 months
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Infections and infestations
Infection
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Infections and infestations
Klebsiella infection
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Infections and infestations
Pneumonia
|
22.2%
2/9 • Number of events 2 • 2 months
|
|
Infections and infestations
Pneumonia bacterial
|
22.2%
2/9 • Number of events 2 • 2 months
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
2/9 • Number of events 2 • 2 months
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • Number of events 3 • 2 months
|
|
Investigations
Hepatic enzyme increased
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
22.2%
2/9 • Number of events 3 • 2 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
22.2%
2/9 • Number of events 2 • 2 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
22.2%
2/9 • Number of events 3 • 2 months
|
|
Nervous system disorders
Polyneuropathy
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Psychiatric disorders
Anxiety
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Renal and urinary disorders
Renal impairment
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
11.1%
1/9 • Number of events 1 • 2 months
|
|
Vascular disorders
Haematoma
|
11.1%
1/9 • Number of events 1 • 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER