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Clinical trial to repurpose existing drugs for COVID-19 treatments

Apr 21 2020

Professor Josh Davis

HMRI is delighted to be involved in a new clinical trial aimed at testing the safety and efficacy of existing drugs for patients hospitalised with COVID-19

Led by Associate Professor Steven Tong, a Royal Melbourne Hospital infectious diseases clinician and co-lead of clinical research at the Doherty Institute, the AustralaSian COVID-19 Trial (ASCOT) plans to recruit patients in over 70 hospitals across the country, in every state and territory, alongside 11 hospitals in New Zealand. HMRI Clinical Trial Unit is establishing the NSW and ACT sites in readiness for patient recruitment. Professor Josh Davis, is ASCOT Principal Investigator based at the John Hunter Hospital and an affiliate of the Hunter Medical Research Institute.

As a ‘new disease’ there are currently no treatments with established effectiveness for COVID-19.

However, there are multiple drug 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 Organization 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.”

Associate Professor Tong confirmed that patients are being actively screened for recruitment to the trial at The Royal Melbourne Hospital. “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.

“We plan to have other trial sites up and running later this week across Australia and to significantly contribute to the limited body of knowledge on how to treat COVID-19.”

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.

Philanthropy has played a significant role in funding ASCOT with generous commitments from the Royal Brisbane and Women’s Hospital Foundation via a crowdfunding campaign, Anthony Pratt and The Pratt Foundation and the Minderoo Foundation.

Andrew and Nicola Forrest’s Minderoo Foundation has generously committed $1 million to support the AustralaSian COVID-19 Trial (ASCOT),

The Foundation announced earlier this month it had committed AU$160 million to fight the COVID-19 pandemic, including sourcing and transporting millions of pieces of personal protective equipment and medical supplies from China to Australia.

Minderoo Foundation Chairman Dr Andrew Forrest AO said a key component of the Foundation’s pledge to defeat the virus was funding research and clinical trials. “We are most excited about supporting high quality clinical trials that can help patients and healthcare workers during this pandemic, not after it has passed.” Dr Forrest said.

“This trial will address the approximate 20 per cent of COVID-19 sufferers who have to go to hospital, and aims to help reduce the number of those who would typically progress to intensive care.” Dr Forrest said.

For more information on ASCOT, visit the website.

HMRI Clinical Trials Unit is coordinating the clinical trial roll-out in NSW and the ACT. We’ll be sharing more information about this partnership in the coming days and weeks so stay tuned.

*Professor Josh Davis, ASCOT PI, Hunter Medical Research Institute, Menzies School of Health Research, President of the Australasian Society for Infectious Diseases and clinician researcher at the John Hunter Hospital, Newcastle.