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New coronavirus drug trial commences across Australia


Anastasia Tsirtsakis


21/04/2020 4:58:56 PM

The first trial site has opened at the Royal Melbourne Hospital, testing the effectiveness of lopinavir-ritonavir and hydroxychloroquine.

Scientist conducting laboratory test.
Lab testing of lopinavir-ritonavir and hydroxychloroquine has shown promise for the potential treatment of COVID-19.

Laboratory testing on lopinavir-ritonavir (currently used to treat HIV), and hydroxychloroquine (used to treat arthritis and malaria), has shown great promise for the potential treatment of COVID-19.
 
Now a team of researchers across Australia and New Zealand are setting out to see if the drugs are a safe and effective treatment for the disease in humans.
 
The Australasian COVID-19 Trial (ASCOT) will test lopinavir-ritonavir and hydroxychloroquine in patients hospitalised with coronavirus in more than 70 hospitals across Australia and 11 hospitals in New Zealand.
 
The study, led by Associate Professor Steven Tong, an RMH infectious diseases clinician and co-lead of clinical research at the Doherty Institute, aims to test whether use of these drugs will prevent patients deteriorating to the point of needing a ventilator in the intensive care unit (ICU).
 
‘We have designed the trial so that it’s responsive and adaptive,’ Associate Professor Tong said. ‘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.’
 
Key partner organisations involved in the trial include 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.
 
‘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,’ Associate Professor Tong said.
 
‘Ideally, as other potential treatments become available, these can also be tested within the coordinated framework of ASCOT.’
 
ASCOT is a randomised trial, which will see patients randomly allocated to different treatments, while some will not receive either drug.
 
‘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,’ Associate Professor Tong said.
 
Ritonavir-lopinavir and hydroxychloroquine are two of four promising treatments for coronavirus included by the World Health Organization (WHO) in its large global trial, SOLIDARITY.
 
In its latest update on antiviral and antimalarial use for coronavirus patients, the National COVID-19 Clinical Evidence Taskforce in Australia said there is currently insufficient evidence regarding their benefits and harms, and at this they stage should only be administered in the context of clinical trials.
 
Patients are now being actively screened for recruitment into ASCOT at the RMH, with plans to have other trial sites set up and running across the country later this week.
 
The RACGP has more information on coronavirus available on its website.
 
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clinical trials coronavirus COVID-19 hydroxychloroquine lopinavir-ritonavir



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Dr Horst Paul Herb   22/04/2020 9:03:06 PM

Regarding Hydroxychloroquine, there is a bad "study" that never deserved being published in the first place (France, combined HCQ and Azithromycin)
but also a much better designed and powered one that nobody seems to mention at all (http://dx.doi.org/10.1101/2020.03.22.20040758) - why is that?
We also know that HCQ acts as Ionophore for zinc, and zinc has been demonstrated to be helpful in a number of viral infections - so why is it not included as an adjunct in that trial?


Dr Christopher St John Kear   24/04/2020 1:21:33 PM

I think we're behind the times in putting hydroxychloroquine in the mix here. It's been pretty roundly rebuffed as an effective tool, and it is toxic, particularly to the kind of patients you'll find on an ICU. I'd have just stuck with the antivirals and left the toxic and at the very best, largely ineffective plaquenil out of the cocktail.