Launched on Tuesday, the ASCOT Trial is being progressively rolled out in hospitals across Australia and New Zealand, led by the Australasian Society for Infectious Diseases Clinical Research Network, coordinated by the Melbourne’s Doherty Institute in partnership with HMRI, and the University of Queensland Centre for Clinical Research/Royal Brisbane and Women’s Hospital.
Researchers will compare data from four arms of the trial, with patients being randomly selected to receive either the drug Lopinavir-Ritonavir, which is currently used to treat HIV, a malaria medication hydroxychloroquine, a combination of both compounds, or standard care.
HMRI affiliated researcher and Infectious Diseases expert Professor Josh Davis says the aim is to trial these therapies on patients admitted to hospital, before they deteriorate to the point of needing a ventilator. Around 2000 patients are set to be recruited over the next 12-18 months.
“Working in harmony with leaders of other trials globally, the ASCOT trial will significantly contribute to the body of knowledge on how we treat COVID-19,” Professor Davis said.
ASCOT is also designed to be responsive and adaptive, which means that new drugs can be added if they show promise. Similarly, if a drug doesn’t appear effective or causes severe side effects it can be suspended immediately.
Clinical trials are complex to establish, often taking a year or more to complete background work before patients are recruited. So for ASCOT to be running in less than two months for patient recruitment is huge testament to its lead collaborators and those who have supported its funding and establishment.
HMRI Institute Director Professor Tom Walley says ASCOT is one of the largest clinical trials of its kind in Australia: “Some of the participating hospitals are less accustomed to operating as clinical trial sites, so we’re working with them to run the trial while continuing to deliver high standards of healthcare to their patients.”
HMRI’s Clinical Trials Unit (CTU) will coordinate the 26 trial sites in NSW and the ACT. These include Canberra Hospital, John Hunter Hospital, Royal Prince Alfred Hospital, Westmead, Port Macquarie Base Hospital, Calvary Mater Newcastle and St Vincent’s Hospital Sydney.
CTU Director Associate Professor Craig Gedye says clinical trials are vital in determining how well a particular therapy works (efficacy) and, more importantly, how safe they are for frontline treatment.
“With the ASCOT trial we’re testing drugs that we know are effective and well-tolerated in people with certain medical conditions – but what we don’t know is how well they will work on people with this specific virus.”
The HMRI CTU was established to provide specialist support for the teams who initiate and run them.
“An effective clinical trial has many elements and challenges to it, the design, the governance, the administration, the recruitment, data collection and analysis, not to mention the funding,” Associate Professor Gedye adds.
“Our team has extensive experience in running effective clinical trials and this project presents the perfect opportunity to support clinicians and their patients in finding better outcomes for people with COVID-19.”
For more information on HMRI’s COVID-19 Research and activity visit – www.hmri.org.au/coronavirus-covid19
For more information on ASCOT, visit http://www.ascot-trial.edu.au