The Hunter Medical Research Institute [HMRI] will play a key role in a nationwide clinical trial into potential treatments for COVID-19.
The ASCOT trial will involve researchers testing drugs on patients hospitalised with COVID-19. Patients will be randomly selected to receive one of four different treatments. They will receive either the drug Lopinavir-Ritonavir [an HIV medicine], hydroxychloroquine [a malaria medicine] or a combination of both those drugs. The fourth group will receive standard care without the drugs.
HMRI-affiliated researcher and infectious diseases expert, Professor Josh Davis, said the therapies would be trialled on patients before they deteriorate to the point of needing a ventilator.
About 2000 patients are set to be recruited at hospitals, including John Hunter and Calvary Mater Newcastle, over the next 12 to 18 months.
ASCOT is designed to be responsive and adaptive, which means that new drugs can be added if they show promise. And if a drug doesn't appear effective or causes severe side effects, it can be suspended.
Clinical trials are complex to establish, often taking a year or more to complete background work before patients are recruited.
For the ASCOT trial to be running in less than two months reflects the urgency of the coronavirus crisis.
HMRI Institute director Professor Tom Walley said ASCOT was "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," he said.
HMRI clinical trials unit director, Associate Professor Craig Gedye, said clinical trials were vital for determining how well a particular therapy works 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 clinical trials unit 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 - design, governance, administration, recruitment, data collection and analysis - not to mention the funding," Associate Professor Gedye said.
"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 hmri.org.au/coronavirus-covid-19.
For more information on ASCOT, visit ascot-trial.edu.au.
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