AstraZeneca begins international randomized clinical trial of calibrating in the treatment of excessive immune response (cytokine storm), caused by infection COVID-19 in patients with severe form of the disease.
Clinical study developed on the basis of scientific evidence supporting the role of Bruton’s tyrosine kinase (TKB) in the cascade reactions aimed at the production of inflammatory cytokines, and based on the results of early phase clinical research. Calibrating is a highly selective inhibitor of TKB new generation currently used to treat certain types of leukemia.
The study CALAVI are data showing that the reduction of the inflammatory process caused by the inhibition of TKB, apparently, reduces the severity of respiratory syndrome, caused by COVID-19. The purpose of the study was to assess the efficacy and safety of the use of calibrating as a Supplement to the optimal maintenance therapy (OPT) to reduce mortality and need for mechanical ventilation in patients with life-threatening symptoms COVID-19.
In the first part of the study will be assessed the addition of calibrating to OPT compared with OPT without the addition of the drug in patients hospitalized with a diagnosis of COVID-19 and not in intensive care units and intensive care unit (Picu). The second part investigates the efficiency of adding calibrating to OPT in patients in the ICU.