The trial, called CALAVI, evaluates the effect of Calquence on the exaggerated immune response of patients hospitalised with COVID-19 infection
CALAVI trial will evaluate the effect of Calquence on COVID-19 patients. (Credit: AstraZeneca.)
AstraZeneca will initiate a randomised clinical trial to evaluate the potential of Calquence (acalabrutinib) to treat the exaggerated immune response (cytokine storm) in COVID-19 patients.
The clinical trial has been designed based on early clinical data and the scientific evidence supporting the role of Bruton’s tyrosine kinase (BTK) pathway in the production of inflammatory cytokines.
Calquence is an advanced, highly selective BTK inhibitor that binds covalently to BTK to inhibit its activity, and is currently used to treat certain types of blood cancers.
AstraZeneca oncology R&D executive vice president José Baselga said: “With this trial, we are responding to the novel insights of the scientific community and hope to demonstrate that adding Calquence to best supportive care reduces the need to place patients on ventilators and improves their chances of survival. This is the fastest launch of any clinical trial in the history of AstraZeneca.”
Assisted ventilation or death includes the primary endpoint for CALAVI clinical trial
CALAVI is a large, randomised, open-label, multicentre, global, two-part clinical trial, aimed at assessing the efficacy and safety of Calquence, along with best supportive care (BSC) to reduce mortality and the need for assisted ventilation in patients with COVID-19 symptoms.
The trial will evaluate Calquence with BSC, compared to BSC alone in patients hospitalised with respiratory complications of COVID-19. It is expected to enrol participants in the US and in several countries in Europe.
The study is randomised into two parts where one part will evaluate the addition of Calquence to current BSC in patients who are hospitalised but not on assisted ventilation and not in the ICU.
The second part will evaluate Calquence plus BSC compared to BSC in a cohort of patients in the ICU with more severe respiratory complications. The primary endpoint would measure the use of assisted ventilation or death.
CALAVI trial principal investigator Louis M Staudt said: “Given the well-documented role of the protein BTK in regulating inflammation, it is possible that inhibiting BTK with acalabrutinib could provide clinical benefit in patients with advanced COVID-19 lung disease.
“As with all new treatments, it will be necessary to gather data from clinical trials in order to understand the best and safest treatment options for patients.”