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Hydroxychloroquine drug trial set for high-risk healthcare workers
The first gold standard Australian clinical trial to determine whether the drug can help prevent COVID-19 is now open.
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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