In the trial, AstraZeneca will assess the effect of Calquence on the exaggerated immune response of patients hospitalized with COVID-19 infection.

The company announces that it will initiate a randomized, global clinical trial to assess the potential of Calquence (acalabrutinib) in the treatment of the exaggerated immune response (cytokine storm) associated with COVID-19 infection in severely ill patients. The trial design is based upon scientific evidence supporting the role of the Bruton’s tyrosine kinase (BTK) pathway in the production of inflammatory cytokines and on encouraging early clinical data, reports the company. Calquence is a next-generation, highly selective BTK inhibitor currently used to treat certain types of blood cancers.

A two-part patient-centric design

The trial, called CALAVI, is based on early clinical data with Calquence demonstrating that a decrease in inflammation caused by BTK inhibition appears to reduce the severity of COVID-19-induced respiratory distress. The goal of the trial is to evaluate the efficacy and safety of adding Calquence to best supportive care (BSC) to reduce mortality and the need for assisted ventilation in patients with life-threatening COVID-19 symptoms.

This large trial uses a two-part patient-centric design developed in record time to accelerate data capture and analysis.

Part one evaluates the addition of Calquence to BSC versus BSC alone in patients hospitalized with COVID-19 who are not in the intensive care unit (ICU). Part two evaluates the addition of Calquence to BSC in a cohort of patients in the ICU.

“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,” says José Baselga, Executive Vice President, Oncology R&D, AstraZeneca.

Open for enrolment in the coming days

The CALAVI trial is expected to open for enrolment in the coming days in the US and several countries in Europe.

Wyndham H. Wilson, MD, PhD, of NCI in the US, will serve as the principal investigator of the trial. Louis M. Staudt, MD, PhD will serve as senior investigator.

Photo of José Baselga: AstraZeneca