On Nov. 12, 2020, AstraZeneca announced that the CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. The addition of Calquence to best supportive care (BSC) did not increase the proportion of patients who remained alive and free of respiratory failure. No new safety signal for Calquence was observed in the trials.

The CALAVI Phase II programme comprised two randomised, open-label, multicentre trials evaluating the efficacy and safety of Calquence with BSC versus BSC alone in patients hospitalised with respiratory complications of COVID-19. The trials were randomised (1:1) and evaluated the addition of Calquence to current BSC in patients who were hospitalised but not on mechanical ventilation and not in the intensive care unit. The primary endpoint measured respiratory failure or death. The trials were conducted in the US (CALAVI US) and in multiple other countries across the world (CALAVI).