A drug is being studied for its effectiveness in treating a type of severe immune overreaction seen in patients with COVID-19-induced pneumonia by researchers at the University of Texas Health Science Center at Houston (UTHealth). The clinical trial is enrolling patients at Harris Health System’s Lyndon B. Johnson Hospital.
The Phase III, multisite, randomized, double-blind, placebo-controlled study is evaluating the effectiveness of the drug canakinumab, an interleukin-1 (IL-1) blocker approved for the treatment of juvenile rheumatoid arthritis, for preventing cytokine release syndrome (CRS) in COVID-19 patients with pneumonia.
Often referred to as a cytokine storm, CRS is a life-threatening immune reaction caused by the body releasing too many cytokines into the blood at once. Cytokines include a broad category of proteins secreted by the body. IL-1 serves as the first-line defense for the immune system, alerting other proteins to respond if a virus or bacteria are present.
Canakinumab blocks the production of IL-1 protein, which could prevent a possible deadly overreaction of the immune system in COVID-19 patients. Research has linked a number of COVID-19 deaths to CRS due to damage caused to several major organs.
The COVID-19 pandemic has reminded researchers at UTHealth of the early days of the HIV pandemic, when confusion and fear affected many communities and few treatment options were available.
Roberto C. Arduino, MD, the study’s lead investigator and professor of infectious disease with McGovern Medical School at UTHealth, said this is a time for the HIV research community to utilize members’ expertise in the search for a treatment for the coronavirus. Arduino’s research background includes the study of new antiretroviral drugs, treatment strategies, immune activation, and inflammation in the search of a HIV cure.
“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,” said Arduino, who has led HIV clinical research for 22 years.
Researchers are investigating if canakinumab combined with standard-of-care treatment can increase the chances of survival without ever requiring invasive mechanical ventilation in patients with COVID-19-induced pneumonia. Over a two-hour period, patients who are enrolled will receive either a 450 mg, 600 mg, or a 750 mg IV dose of canakinumab based on their body weight; or placebo. All participants will be monitored for up to 29 days, or until they are discharged from the hospital. A follow-up will occur at 127 days.
Novartis Pharmaceuticals and the National Institutes of Health AIDS Clinical Trials Network are sponsoring this clinical trial. For more information, visit ClinicalTrials.gov.