Each morning before Claire Lobb sets off to work on the frontline of Victoria’s coronavirus second wave crisis, she pops a mysterious pill.
There’s a 50-50 chance that what she takes is hydroxychloroquine, a controversial drug touted by Donald Trump, that could potentially stop millions of people around the world getting COVID-19.
Alternatively it could be just an extra dose of sugar as a late garnish for her breakfast. She has no way of knowing.
But the simple act she undertakes each morning has the potential to change the world.
It’s part of a groundbreaking trial of the hotly-debated drug here in Australia that has the potential to be a “game-changer” in the global battle against COVID-19.
The cheap and readily available drug has been used for more than 60 years for a variety of reasons. Now researchers behind the trial say it could potentially stop people getting the virus and ultimately save lives.
If successful, it could be used by people who want to travel overseas. They would just have to take it during their trip.
It could protect people who may not be able to take a COVID vaccine for health reasons, or those in countries where a vaccine could take a long time to reach.
It could protect Australians, and people around the world, who are most at risk from COVID-19 including aged care residents and staff, meatworks staff and healthcare workers.
Ms Lobb understands what that means as much as anybody.
As a nurse practitioner at Melbourne’s Alfred Hospital Emergency Department she has been on Australia’s frontline against the coronavirus.
Every day, she is tasked with admitting Melburnians who may or may not have the disease.
“We don’t always know and it can be quite confronting at times not always knowing what we’re dealing with,” she told news.com.au.
With mental health issues in patients spiking and a massive rise in healthcare worker infections in recent weeks, she said work has been “intense and stressful”.
“It hasn’t always a great time to be working just because of the intensity of the situation,” she said.
In late March and early April, Mr Trump repeatedly proclaimed that hydroxychloroquine could prevent or treat COVID-19.
Within days, the number of prescriptions for the drug skyrocketed.
However, the Australian trial, led by the Walter and Eliza Hall Institute, is looking at it from a different angle.
The trial’s lead researcher Professor Marc Pellegrini told news.com.au there has been a storm of confusion looming over hydroxychloroquine ever since the US President’s comments.
However, he believes that should be put to one side and the science should do the talking.
His team started testing healthcare workers in early June in a clinical trial in hospitals along Australia’s east coast – which have been hardest hit by COVID-19.
The aim is simple, to see whether the drug can stop people getting the virus.
“It’s been highly politicised but we thought it’s best to use proper science to understand whether it plays any role in preventing people getting COVID-19,” he said.
There are now roughly 200 medical workers using hydroxychloroquine as part of the trial, and by January next year the results will be in.
It’s too early to say what those results could look like, but Prof Pellegrini says the science already tells us the drug doesn’t work as a late treatment for coronavirus.
However, his team is looking at whether it can be used as something called a pre-exposure prophylaxis, which means it could work as a preventive before someone comes into contact with somebody with COVID-19.
The rationale behind this is that many drugs work very well in preventing people from getting a disease, but when it is well and truly in their system, it falls short.
“Two of our best flu drugs work like that. The anti-HIV drugs work incredibly well at preventing people from getting infected.”
He said it has been proven that hydroxychloroquine works against COVID-19 in a test tube, but there is limited evidence it works clinically.
“It obviously became divisive because it was highly politicised,” he said. “Obviously when politicians who are very polarising make an opinion, which is not based on good science, then it obviously dilutes the potential merit of the drug.
“It’s really important to dissociate the hearsay and the politicisation of the drug from the real evidence. The evidence is in the test tube, but we really need it tested on people.
“It would be very remiss of us to potentially throw away a drug that could potentially be a game-changer in COVID-19 based on the opinions of a few people who have polarised large parts of society.”
Because of the political debate around the drug, he says very poorly-done studies were carried out to show the people weren’t tolerating the drug – which were later disproved and even retracted.
The divisiveness also left people unsure as to whether the drug was safe.
However, Prof Pellegrini assured news.com.au that hydroxychloroquine is safe when taken under a degree of medical supervision. He even compared it to Panadol or Nurofen.
“It’s a drug that’s been around for 60 years and it’s used routinely, so we know all the side effects,” he said.
“If you give it to the wrong person they could get into trouble. But obviously we’re being incredibly careful in making sure we’re giving the drug under the strictest medical supervision. The reason being is that we haven’t proven the drug works under these circumstances.”
He said there were fears the drug may cause abnormalities in the heartbeat, however there is no evidence to back this up.
“It can cause tummy upsets as can any drug, but the main concern was its effect on the heart and it’s been categorically shown in the big treatment studies that the drug simply doesn’t have the capacity to cause any major untoward effects in causing heart disease.”
Trial participant Ms Lobb said the media storm over the drug has made getting real evidence about it difficult.
“That politicisation of the drug hasn’t been helpful at all,” she said. “The most important thing we need here is evidence-based therapy and that’s why we’re having a clinical trial.
“It’s been very difficult because a lot of people don’t understand, they hear hydroxychloroquine and think it’s a stupid drug because it was supported by Donald Trump.”
However, as a nurse practitioner, Ms Lobb said she’s too qualified to pay attention to the media rhetoric, especially since she has dealt with the drug over many years.
“We’re health care professionals and we’re guided by evidence-based practice, so a rhetoric in the media is not going to influence my decision to do a drug trial or not,” she said. “In fact it reinforces the need to do it even more.”
The incentive to discover whether the drug works against COVID-19 is huge given it is cheap, readily available and shows good signs of working against virus.
Prof Pellegrini said there were many different scenarios the drug could be used in to prevent infection, from overseas travel to protecting workers and staff in aged care homes.
“For example if there was a case in a meatworks or an aged care, you’d go there and give the drug to all the residents or workers to try to prevent them getting COVID-19,” he said.
“And people who are travelling for work in an area where there is a lot of COVID-19, they could take this drug for the time that they’re in these high-risk zone.”
However, even if the drug works, he said it will not be a replacement for a vaccine.
He says a vaccine will take a long time to test – up to a year or more – and there’s no guarantee it will be 100 per cent effective.
“So if there’s a drug that’s readily available and clinically well-tolerated then it would probably be best to start using that drug to prevent people getting infected while we’re waiting for a vaccine,” he said. “Also, no vaccine is 100 per cent effective, so we will always need a back-up.”
Ms Lobb, meanwhile, is about two-thirds of the way through her four month trial and there have been no side effects so far. She also hasn’t contracted COVID-19, although it’s worth pointing out again that she could be on a placebo.
All she does is take the pill each morning and fill a short survey on her phone.
She see it as just one small way she can help the world beat this virus. She wants more people to get involved.
“It could be really important because we don’t know when a vaccine’s coming along and not all countries are going to have access to the vaccine,” she said.
“We’ve got to think about our Third World colleagues who won’t be able to have access or afford a vaccine.”
The trial is a randomised, double-blind, placebo-controlled study – the gold standard – and has been reviewed by the Human Research Ethics Committee at Melbourne Health and multiple NHMRC-accredited bodies.
The trial is open to any healthcare worker in Australia who is at risk of contracting COVID-19.