Canakinumab To Be Tested for Preventing COVID-19 ‘Cytokine Storm’ in Phase III Clinical

A Texas-based study is enrolling patients in its phase 3 clinical trial of arthritis drug canakinumab to see if it effectively prevents cytokine release syndrome (CRS) in COVID-19 patients with pneumonia.

Canakinumab is being tested by researchers at McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth); patients are being enrolled Harris Health System’s Lyndon B. Johnson Hospital.

The interleukin-1 (IL-1) blocker is being tested in UTHealth’s multisite, randomized, double-blind, placebo-controlled study to see if combination canakinumab and standard-of-care treatment increases survival without invasive ventilation in patients with COVID-19 pneumonia. Patients will randomly receive either intravenous canakinumab (450 mg, 600 mg, or 750 mg, depending on the patient’s body weight) or placebo over the course of two hours. Patients will be monitored for up to 29 days or until hospital discharge and will be followed up with at 127 days.

A “cytokine storm” has been associated with the virus. This refers to COVID-19 patients who appear to be getting better, then rapidly deteriorate. This happens when the body is no longer fighting off the virus but instead starts attacking its own immune system. Cytokine storms are seen in patients with rheumatic diseases as well as cancer.

Robert C. Arduino, MD, professor if infectious disease for McGovern Medical School at UTHealth, will lead the study. Dr. Arduino has been involved in and led research HIV research for more than two decades, including new antiretroviral drugs, immune activation, inflammation, and more. He believes that those conducting HIV research should use lend their expertise to the COVID-19 research effort.

“The research community truly feels compelled to do something in the search for a viable treatment for COVID-19, and I feel I owe it to my community to offer my expertise,” Dr. Arduino said, according to UTHealth.

Canakinumab: Indications, New Approvals

Canakinumab was first approved by the FDA in 2009 to treat children aged four and older as well as adults with Cryopyrin-Associated Periodic Syndromes. In 2013 it was approved to treat active systemic juvenile idiopathic arthritis (SJIA) in patients aged two and older. In 2016 three new indications were added, for both adults and pediatric patients: Tumor Necrosis Factor Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, and Familial Mediterranean Fever.

Just this month, the FDA also approved canakinumab for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). SJIA and AOSD share common symptoms, including fever, rash, and elevated inflammatory markers.