Researchers in Brisbane are to start a randomised controlled trial of tocilizumab as a treatment for patients with severe inflammatory complications of COVID-19 disease.
The IL-6 inhibitor already used for cytokine release syndrome in patients receiving CAR T-cell treatment, and will be trialled in COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS).
The trial is being led by QIMR Berghofer Associate Professor Bridget Barber, an infectious diseases physician at the Royal Brisbane and Women’s Hospital. The trial will initially involve intensive care patients from this and other Metro North sites such as the Redcliffe Hospital.
Associate Professor Barber said high levels of the inflammatory molecule IL6 have been detected in critically ill COVID-19 patients.
“We hope that tocilizumab will improve outcomes in critically ill patients by blocking this key inflammatory molecule IL-6, and preventing some of the damage that is caused by this inflammatory response.”
She said a small, observational study of the drug in Italy had shown some promising early results with tocilizumab, but a prospective randomised controlled trial is needed to provide more evidence of efficacy.
“Fortunately, Australia has seen a big fall in COVID-19 cases; however, we do expect that a small number of patients will continue to become infected and will require admission to ICU,” Associate Professor Barber said.
“More importantly, we need to be prepared for the possibility that cases may increase again at a later stage. If Australia does see an increase in cases in the coming months, the trial will be available to critically ill patients at participating hospitals.
In the study, two thirds of the patients recruited will be given tocilizumab and their responses will be monitored and compared to the one third of patients who will not get the treatment.
Associate Professor Barber is collaborating with expert immunologists at QIMR Berghofer, including the head of the Institute’s Immunology and Infection group, Professor Christian Engwerda, so that the effect of tocilizumab on patients’ immune systems can be studied.
“Tocilizumab has already gone through regulatory approvals and we know the side effects it could pose, so it is relatively straightforward to evaluate it in a clinical trial to see if it will improve outcomes and reduce the risk of death in patients with COVID-19,” she said.