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AcalabrutinibWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug1018 Placebo (Plasma-Lyte 148) Wiki 0.71
drug586 Human umbilical cord derived CD362 enriched MSCs Wiki 0.71
drug1139 Recombinant human alkaline phosphatase Wiki 0.71
drug1016 Placebo Wiki 0.05

Correlated MeSH Terms (6)

Name (Synonyms) Correlation
D018805 Sepsis NIH 0.41
D058186 Acute Kidney Injury NIH 0.24
D013577 Syndrome NIH 0.09
D055371 Acute Lung Injury NIH 0.08
D012127 Respiratory Distress Syndrome, Newborn NIH 0.08
D012128 Respiratory Distress Syndrome, Adult NIH 0.07

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials

1 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

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

NCT04346199 COVID-19 Drug: Acalabrutinib

Primary Outcomes

Description: Respiratory failure, is defined based on resource utilization of any of the following modalities: Endotracheal intubation and mechanical ventilation 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) Noninvasive positive pressure ventilation or continuous positive airway pressure Extracorporeal membrane oxygenation

Measure: Subject alive and free of respiratory failure

Time: Day 14

Secondary Outcomes

Measure: Proportion of subjects alive and free of respiratory failure

Time: Day 28

Measure: Percent change from baseline in CRP

Time: Days 3, 5, 7, 10, 14, 28

Measure: Change from baseline in ferritin

Time: Days 3, 5, 7, 10, 14, 28

Measure: Chnage from baseline in absolute lymphocyte counts

Time: Days 3, 5, 7, 10, 14, 28

Measure: All cause mortality

Time: Day 90

Measure: Proportion of subjects alive and discharged from ICU

Time: Days 14 and 28

Measure: Time from randomization to first occurrence of respiratory failure or death on study due to any cause

Time: Up to 28 days after randomization

Measure: Number of days alive and free of respiratory failure

Time: To 28 days after randomization

Measure: Number of days with respiratory failure

Time: to 28 days after randomization

Measure: Number of days hospitalized

Time: To 28 days after randomization

Measure: Number of days in ICU (length of stay)

Time: To 90 days after randomization

Measure: Number of days alive outside of hospital

Time: To 28 days after randomization

Measure: Number of days alive outside of hospital

Time: To 90 days after randomization

Measure: Relative change from baseline in oxygenation index (PaO2/FiO2)

Time: To Day 5

Description: 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.

Measure: Occurrence of Adverse Events and Serious Adverse Events

Time: 28 days after last dose

Description: Peak Plasma Concentration (Cmax)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Cmax)

Time: 28 days after last dose

Description: Time to Maximum Concentration (Tmax)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Tmax)

Time: 28 days after last dose

Description: Area under the plasma concentration versus time curve (AUC)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (AUC)

Time: 28 days after last dose

2 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

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

NCT04380688 COVID-19 Drug: Acalabrutinib

Primary Outcomes

Description: 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.

Measure: Occurrence of Adverse Events and Serious Adverse Events

Time: 28 days after last dose

Description: Respiratory failure, is defined based on resource utilization of any of the following modalities: Endotracheal intubation and mechanical ventilation 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) Noninvasive positive pressure ventilation or continuous positive airway pressure Extracorporeal membrane oxygenation

Measure: Subject alive and free of respiratory failure

Time: Day 14

Secondary Outcomes

Measure: Proportion of subjects alive and free of respiratory failure

Time: Day 28

Measure: Percent change from baseline in CRP

Time: Days 3, 5, 7, 10, 14, 28

Measure: Change from baseline in ferritin

Time: Days 3, 5, 7, 10, 14, 28

Measure: Change from baseline in absolute lymphocyte counts

Time: Days 3, 5, 7, 10, 14, 28

Measure: All cause mortality

Time: Day 90

Measure: Proportion of subjects alive and discharged from ICU

Time: Days 14 and 28

Measure: Time from randomization to first occurrence of respiratory failure or death on study due to any cause

Time: Up to 28 days after randomization

Measure: Number of days alive and free of respiratory failure

Time: Up to 28 days after randomization

Measure: Number of days with respiratory failure

Time: Up to 28 days after randomization

Measure: Number of days hospitalized

Time: Up to 28 days after randomization

Measure: Number of days in ICU (length of stay)

Time: Up to 90 days after randomization

Measure: Number of days alive outside of hospital

Time: Up to 28 days after randomization

Measure: Number of days alive outside of hospital

Time: Up to 90 days after randomization

Measure: Relative change from baseline in oxygenation index (PaO2/FiO2)

Time: Up to Day 5

Description: Peak Plasma Concentration (Cmax)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Cmax)

Time: 28 days after last dose

Description: Time to Maximum Concentration (Tmax)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Tmax)

Time: 28 days after last dose

Description: Area under the plasma concentration versus time curve (AUC)

Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (AUC)

Time: 28 days after last dose

No related HPO nodes (Using clinical trials)