Novartis To Begin Phase III Clinical Trial of Autoimmune Disease Drug in COVID-19 Patients with Pneumonia

Novartis (Basel, Switzerland) will initiate a Phase III clinical trial to examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia.

The study builds on early evidence from lab tests of COVID-19 patients who showed elevated IL-1β levels, among other cytokines. For the CAN-COVID trial, Novartis aims to rapidly enroll 450 patients at multiple medical centers across France, Germany, Italy, Spain, the UK and US and randomize them to receive either canakinumab or placebo on top of standard of care (SoC).

The primary objective of the study is to demonstrate the benefit of canakinumab in combination with SoC in increasing the chance of survival without the need for invasive mechanical ventilation among patients with COVID-19 pneumonia. Top-line results are anticipated late summer 2020.

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