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Hydroxychloroquine drug trial set for high-risk healthcare workers


Anastasia Tsirtsakis


20/05/2020 4:03:33 PM

The first gold standard Australian clinical trial to determine whether the drug can help prevent COVID-19 is now open.

Hydroxychloroquine tablets
The study is the first to test the antiviral as a prophylaxis to prevent COVID-19. (Image: AAP)

‘The community is highly dependent on healthcare workers being able to come to work and do their job safely – the whole point of the trial is to protect them.’
 
That is Professor Ian Wicks, one of the lead investigators in the COVID SHIELD clinical trial and joint head of Clinical Translation at the Walter and Eliza Hall Institute (WEHI) of Medical Research.
 
Recruitment for the trial has commenced, with approximately 2250 healthcare workers expected to take part.
 
For a duration of four months, half of the participants will be given hydroxychloroquine and the other half will receive a placebo.
 
‘We can’t stress enough the fact that it’s been rigorously designed with a placebo-controlled study and a double-blinded study,’ Professor Wicks told newsGP.
 
‘So neither the participants nor the investigators know who’s taking what – that’s the highest level of evidence and that’s really what’s been missing in this discussion.
 
‘Our frontline healthcare workers are dealing with these patients and are at risk, and so over and above all the other measures that we’re taking, this could provide another level of prevention.’
 
Hydroxychloroquine has made headlines in recent months, after being touted by US President Donald Trump as a ‘miracle’ drug for the treatment of COVID-19. A number of trials are taking place around the world to clarify whether that is the case, so far with varying results.
 
But the COVID SHIELD study is the first to test the antiviral as a preventive against COVID-19.
 
‘The publicity along the way has, I think, been based on opinion, not fact, and we’re just trying to move it from that so that we’re actually providing definitive evidence one way or the other,’ Professor Wicks said.
 
‘In in vitro test tube-type experiments, hydroxychloroquine was shown to have inhibitory effects on the virus – at doses that would be equivalent to what we achieve when we treat people.
 
‘So putting those two things together, I think, stacks up as a reasonable risk benefit scenario until we get a vaccine.’
 
Professor Wicks says it is reassuring that the drug is well known to clinical medicine, used in rheumatology for more than 50 years.
 
‘So we’re pretty comfortable,’ Professor Wicks said.
 
‘It does have side effects, but we’re very aware of those, they’ve been well documented. So we’ll screen for those in this study.
 
‘The kind of pushback there’s been in the media about not just rushing out and taking it unsupervised is very important – we’d absolutely agree with that. It’s prescription medicine, it needs to be taken under medical supervision.’
 
All participants will be screened based on a rigorous selection criteria and closely monitored throughout the trial to ensure safety.
 
Anyone who has had a heart rhythm disturbance or retinal disease of any kind will be excluded, given the drug is uncommonly known to worsen such conditions.
 
Since word of hydroxychloroquine spread to the general public, there has been concern over supply shortage. But Professor Marc Pellegrini, co-lead investigator in the trial and joint head of Infectious Diseases and Immune Defence at WEHI, assures the antivirals being used have been supplied by the manufacturer specifically for the trial.
 
‘COVID SHIELD will not be diverting hydroxychloroquine for routine use from pharmacies, hospitals, or other patient supply chains,’ he said.
 
The trial will focus on high-risk healthcare workers who work directly with COVID-19 patients in either hospital settings, such as emergency and intensive care, or in fever clinics.
 
If the trial is successful and hydroxychloroquine is shown to have a protective effect, Professor Wick said there is potential for the trial to be extended to primary care practitioners, paramedics and aged care workers.
 
‘When the study was first being designed there were grave concerns about the ability of the hospital system to cope and so we’ve started the study in hospital healthcare workers where we’re pretty sure about the work environment,’ he said.
 
‘It is a little trickier doing that in primary care where somebody might move between different environments doing different things with different levels of exposure. But certainly in the future, I think that’s an obvious potential extension of the study.’
 
Frontline and allied healthcare workers who wish to participate in the trial can check their eligibility for the study on the COVID SHIELD Trial website.
 
The RACGP has more information on coronavirus available on its website.
 
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Dr Cho Oo Maung   21/05/2020 9:42:00 AM

I have been taking 1/4 of RAW onion , 1 cm of Ginger at dinner for more than decade especially whenever increase number of URTI associated with weather changes. Treating URTI about 10 patients a days including flu patients without having flu vaccination by myself as a trial. I never get sick more than half day. Never took sick days in my GP life more than 35 years.

I rather continue this than this chemical pill, called, Hydroxychloroquine. Why people not wish to make make themselves not which to do more nature and herbal way for trial?


Dr Ian Mark Light   21/05/2020 10:45:16 AM

The great difference from other trials is it’s use for prophylaxis rather than treatment once the Covid 19 has taken hold.
The same probably for Convalescent serum .
But it is a irony that the concept of treatment with hydroxychloroquine once the Covid 19 has infected a person has been criticised as dangerous .
Other workers are at risk now in particular teachers and in the United Kingdom councils have refused to open schools though the Covid is circulating much more severely in Britain than Australia
If the schools go back all students and teachers ought be tested by swabs the classrooms have to be well ventilated and even held outside with microphones and speakers when the weather allows as viral spread is sparser in the open air particularly with physical distancing .


Dr Arun Kumar Saha   21/05/2020 10:47:46 AM

AT LEAST TRY SOMETHING.HOPE FOR THE BEST


Dr Peter James Strickland   21/05/2020 11:44:43 AM

My clinical inkling is that hydroxychloroquine may well be useful in preventing the inflammatory vasculitis that some get (including children ) which affects blood vessels in the lung, heart and those going to the brain (carotids and vertebral); work in the USA by neurologists are suspicious that this is the reason for some suffering strokes secondary to this Covid 19 infection. There should be more publicised studies on any post-mortem findings on whether a vasculitis or carditis etc occurs causing deaths from this virus.


Dr Leonard William Henson   21/05/2020 12:45:17 PM

To allege that Pres Trump touted Plaquenil as a miracle drug, and quoting the fake news NYT as your source, smacks of dishonesty. The President quite rightly reported that the drug could be used. Stop the Trump deranged bashing!


Dr James Gerard Kennedy   21/05/2020 9:46:03 PM

Dr Leonard William Henson I agree. The reporting on this has been far more hysterical than what Trump actually says. It’s odd how biased the reporting on him can be.


Dr Olurotimi Orekoya   22/05/2020 1:36:44 AM

Growing up in Nigeria where Malarial attacks were very prominent, chloroquine was the major antimalarial used to tackle the disease.
The most dreaded side effect for the average person was the horrendous itching it provoked in some people. It was a complete turnoff.
Is hydroxychloroquine different in this regard?


Dr Rahul Kalon   22/05/2020 10:25:04 PM

Many would want the trial to fail even at the costs of lives as Trump may take some credit :)


Dr Marsh   23/05/2020 7:47:25 AM

Please stop asserting that clinical trials started ‘after’ the infamous Trump opened his little mouth on the subject! I have to keep repeating myself, but just because trump said something doesn’t make what he said automatically wrong, and I had researched this clinical question in February long before Trump said anything and found a weighty gold mine of journal literature about its use with SARS of 2003 and MERS in 2012, and Chinese studies in January. And the idea that hydroxychloroquine is some sort of ‘deadly’ drug is quite rudely misleading as well. There is so much bias ejected but mainstream media it makes me wonder what other things I can’t trust them on. Trump has some obvious character and mental health problems that make him an easy target but since when was it ok to discriminate against people on their mental health condition? And then spread so much misinformation about absolutely everything he says even if it will help people!