There are 2 clinical trials
CALAVI will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
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 14Description: 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 doseDescription: Peak Plasma Concentration (Cmax)
Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Cmax) Time: 28 days after last doseDescription: Time to Maximum Concentration (Tmax)
Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Tmax) Time: 28 days after last doseDescription: 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 doseCALAVI US will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.
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 doseDescription: 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 14Description: Peak Plasma Concentration (Cmax)
Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Cmax) Time: 28 days after last doseDescription: Time to Maximum Concentration (Tmax)
Measure: Pharmacokinetics of acalabrutinib and its active metabolite ACP- 5862 (Tmax) Time: 28 days after last doseDescription: 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