Queensland researchers are preparing to begin a clinical trial of a drug that regulates inflammation in the hope it may help save the lives of critically ill patients with COVID-19.
The immunoregulatory drug Tocilizumab* is used to treat rheumatoid arthritis and some other inflammatory conditions.
The drug works by blocking an immune system molecule called IL6, which causes inflammation, and is thought to contribute to the severe respiratory failure that can occur in the second week of the COVID-19 illness. Australia’s Therapeutic Goods Administration approved its use in patients with rheumatoid arthritis in 2009.
The trial is being led by QIMR Berghofer Associate Professor Bridget Barber, who is also an infectious diseases physician at the Royal Brisbane and Women’s Hospital.
Associate Professor Barber said high levels of the inflammatory molecule IL6 have been detected in critically ill COVID-19 patients.
“Intensive care units around the world have reported that many patients deteriorate about a week after they experience the first symptoms of COVID-19,” Associate Professor Barber said.
“Other studies have shown an increase in the patients’ inflammatory response around that time, including high levels of IL6.
“We think it’s this inflammatory response – caused by some parts of the immune system over-reacting to the virus – that is making these patients so unwell.
“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.”
Associate Professor Barber said a small, observational study of the drug in Italy had shown some promising early results, but more research was needed.
“We will be conducting a randomised control trial of the drug, which is the only way of knowing whether or not it is effective,” she said.
“Two thirds of the patients we recruit will be given Tocilizumab and their responses will be monitored and compared to the one third of patients who will not get the treatment.
“It is only through these rigorous clinical trials that we can see whether or not different treatments improve clinical outcomes and survival.”
The trial will initially involve intensive care patients from the Royal Brisbane and Women’s Hospital and other Metro North sites such as the Redcliffe Hospital.
“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.
“There are a number of other randomised controlled trials around the world also evaluating Tocilizumab, however, until we know the results we think it’s important to proceed with this trial in Brisbane.
“It will enable critically ill patients in participating hospitals to be enrolled in the clinical trial, with two-thirds of participants given Tocilizumab.”
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.
“If we do find that the drug is effective, this collaboration will allow us to better understand how the drug is working,” she said.
Associate Professor Barber said it was important to evaluate existing drugs because they could be offered to vulnerable patients relatively quickly.
“Tocilizumab has already gone through regulatory approvals and we know the side effects it could pose, so it is relatively straight-forward 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.
The trial has been submitted for approval to the Royal Brisbane and Women’s Hospital Ethics committee, and once the trial has commenced, patients will only be enrolled when they or their families give permission.
The trial is being funded by philanthropic donations to QIMR Berghofer, including from Clive Berghofer AM and the Brazil Family Foundation.