AstraZeneca 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.
According to the drugmaker, 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 encouraging early clinical data. Calquence is a BTK inhibitor currently used to treat certain types of blood cancers.
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 to reduce mortality and the need for assisted ventilation in patients with life-threatening COVID-19 symptoms.
"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," said José Baselga, executive vice president of Oncology R&D at AstraZeneca. "This is the fastest launch of any clinical trial in the history of AstraZeneca."
The trial is expected to open for enrollment in the coming days in the U.S. and several countries in Europe.
Read the full AstraZeneca release