Novartis has unveiled plans to begin a phase III clinical study to evaluate canakinumab, an interleukin (IL)-1β blocker, in patients with COVID-19 pneumonia.
The CAN-COVID study will assess the efficacy of using canakinumab for the treatment of a type of severe immune overreaction known as cytokine release syndrome (CRS) in people with COVID-19 pneumonia.
The study has been designed based on early evidence from lab tests of COVID-19 patients who elevated IL-1β levels, among other cytokines.
Novartis intends to recruit 450 patients at multiple medical centres across France, Germany, Italy, Spain, the UK and the US.
The company will randomise the patients to secure either canakinumab or placebo on top of standard of care (SoC).
According to the company, the primary objective of the trial is to show the benefit of canakinumab in combination with SoC in increasing the chance of survival without the requirement for invasive mechanical ventilation among patients with COVID-19 pneumonia.
Novartis is planning to reveal the top-line results from the trial in the late summer of this year.
Recently, Novartis has signed an agreement with the US Food and Drug Administration (FDA) to conduct a clinical trial with the hydroxychloroquine in hospitalised COVID-19 patients.
Sponsored by Novartis, the trial will recruit around 440 patients to assess the efficacy of malaria drug to treat hospitalised patients with COVID-19 disease.
Earlier this month, Novartis unveiled plans to commence a clinical trial of Jakavi (ruxolitinib) in severe COVID-19 patients and establish an international compassionate use programme.
Novartis will work with Incyte to begin a phase III clinical study to assess the application of Jakavi to treat cytokine storm, a type of severe immune overreaction that may cause respiratory complications in patients with COVID-19.