Clinical trial into two potential COVID-19 treatments commences
A clinical trial aimed at testing the effectiveness and safety of two existing drugs in patients hospitalised with COVID-19 has opened at the first site, the Royal Melbourne Hospital.
Led by University of Melbourne honorary 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.
As a ‘new disease’ there are currently no treatments with established effectiveness for COVID-19. 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 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),” Associate Professor Tong said.
“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 as of Thursday, 16 April, 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,” Associate Professor Tong said.
“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, Anthony Pratt and The Pratt Foundation and the Minderoo Foundation.
For more information on ASCOT, visit ascot-trial.edu.au.
The Doherty Institute is a joint venture between the University of Melbourne and the Royal Melbourne Hospital.