The Royal Melbourne Hospital (RMH) will be the first site to test the effectiveness of two drugs in fighting COVID-19 in patients who have been hospitalised.
The trial, led by Associate Professor Steven Tong, Infectious Diseases clinician at the RMH and co-lead of clinical research at the Doherty Insitutue will be involved in rectruiting 2500 patients in over 70 hospitals across the country in every state and territory, alongside 12 hospitals in New Zealand.
The AustralaSian COVID-19 Trial (ASCOT) is one way researchers are attempting to see if already established treatments might prove effective against COVID-19 which as a ‘new disease’ has no current treatments.
However, there are multiple treatment options, and combinations, that may be effective. Laboratory tests have shown that lopinavir/ritonavir, which is currently used to treat HIV, and hydroxychloroquine, used to treat arthritis and prevent and treat malaria, can stop SARS-CoV-2, the virus that causes COVID-19, in its tracks.
Associate Professor Tong said that while the World Health Organisation considers both these drugs to be promising treatments for COVID-19, more research is needed to be sure they are safe and effective in humans.
“The aim of ASCOT is to test whether using these drugs will prevent patients deteriorating to the point of needing a ventilator in the intensive care unit (ICU),” said Associate Professor Tong.
“We have designed the trial so that it’s responsive and adaptive. This means that if one of the drugs is proving to be effective, we can adapt the trial to focus on that treatment. Conversely, if a drug isn’t effective, or is causing severe side effects, we can stop it.
“Having such a coordinated approach nationally and in New Zealand means that not only can many patients participate, but we can also generate the evidence as quickly as possible. Ideally, as other potential treatments become available, these can also be tested within the coordinated framework of ASCOT.”
Patients at the RMH are now actively being screened for recruitment for the trial. With plans to expand by the end of the week.
“We plan to have other trial sites up and running later this week across Australia and New Zealand and to significantly contribute to the limited body of knowledge on how to treat COVID-19.”
“ASCOT is a randomised trial, which means that patients will be randomly allocated to different treatments. As is the nature of a clinical trial, some patients will not receive either drug, which is the current “standard of care” for patients with COVID-19,” said Associate Professor Tong.
“This will allow us to answer whether patients who received a specific drug fare better, worse or the same compared to patients who received a different drug or standard of care.
Key partner organisations involved in ASCOT are the Hunter Medical Research Institute, Australasian Society for Infectious Diseases Clinical Research Network and University of Queensland Centre for Clinical Research/Royal Brisbane and Women’s Hospital.