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AstraZeneca has announced it will be commencing a randomized, global clinical trial to assess the efficacy and safety of Calquence (acalabrutinib) in treating the exaggerated immune response of patients with COVID-19.
In an April 14, 2020 press release, AstraZeneca has announced it will be commencing a randomized, global clinical trial to assess the efficacy and safety of Calquence (acalabrutinib) in treating the exaggerated immune response of patients with COVID-19.
Based on early clinical data with Calquence, which demonstrated an apparent reduction in severity of COVID-19 induced respiratory distress by decreasing inflammation caused by Bruton’s tyrosine kinase (BTK), the CALAVI trial will assess whether using Calquence in addition to best supportive care (BSC) can reduce mortality and the need for assisted ventilation in COVID-19 patients. Additionally, the trial will be conducted using a two-part patient-centric design. The first part will assess Calquence with BSC versus BSC alone in the treatment of hospitalized COVID-19 patients who are not in intensive care and the second part will evaluate the addition of Calquence to BSC in a cohort of patients who are already in intensive care.
In the press release, José Baselga, executive vice-president, Oncology R&D, 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.”
“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,” added Louis M. Staudt, MD, PhD, chief of the Lymphoid Malignancies Branch at the National Cancer Institute, in the press release. “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.”
The CALAVI trial is expected to commence shortly in the United States and several European countries.