Hydroxychloroquine trials for COVID wasted time, University of Newcastle professor calls for national expert group to coordinate future trials

Better approach: Newcastle's Professor Jennifer Martin
Better approach: Newcastle's Professor Jennifer Martin

In the panic to find a quick solution for COVID-19, precious time and effort was put into researching treatments unlikely to work, a University of Newcastle researcher says.

Professor Jennifer Martin, clinical pharmacologist and co-director of the National Centre for Drug Repurposing and Medicines Research, wants the COVID-19 response to be a learning moment moving forward.

In a paper recently published in MJA Insight, Professor Martin said it was time to question the assumptions and decisions made internationally in selecting drugs such as hydroxychloroquine for repurposing in COVID-19.

"With hydroxychloroquine, the proper work hadn't been done to know what dose to use and when to use it," she said.

"It is also a drug that you kind of need to have on board for about six weeks before your levels in your blood are adequate."

Professor Martin said the drug would have never usually gotten to clinical trials, as it would have been "weeded out" beforehand due to the side effect profile of the required dose.

"A drug company wouldn't have taken it into clinical trials because it was too risky," she said. "So we were really kind of shocked that first of all, Donald Trump was Tweeting about it, and secondly, that that was the one that was supported for clinical trials - particularly when we had other agents that looked much more hopeful and we knew a lot more about their safety.

"Even though there were publications coming out showing that a) it doesn't work, and b) it causes quite severe toxicity and death, the trials were still going ahead."

The drug was eventually removed from the US Food and Drug Administration (FDA). It had been approved under an emergency use authorisation. The US Strategic National Stockpile was now "laden" with 63 million doses of hydroxychloroquine which have "no clinical use" in COVID-19.

To avoid decisions like this happening again, Professor Martin and her colleagues want to see a national body made up of clinical pharmacologists, physicians, toxicologiosts, epidemiologists, immunologists, infectious disease and public health experts - as well as virologists - working together to design a "priority platform" for Australian research.

"A team with all of those experts on it would be able to prioritise treatments on a national basis, and that way you are not getting competing trials either. It would be a coordinated, cohesive approach," she said. "Next time, before we just launch into something because we are in a panic, we really need a national group of clinical pharmacologists and physicians and job development scientists that work in this area to design a strategy for how we are going to study these patients."

Professor Martin said an international approach to rapidly identify drugs that "treat the host" would help buy time for vaccine and antiviral development.

She said the coordination of the re-purposing of existing drugs was important to ensure time was not wasted, and that the most likely therapeutic targets were chosen for clinical trials.

The World Health Organisation's Solidarity Trial published interim results last week which found that all four treatments evaluated - remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon - had little or no effect on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalised patients with COVID-19.

It found that, so far, only corticosteroids had been proven effective against severe and critical COVID-19.

This story COVID drug plugged by Trump a waste of precious time first appeared on Newcastle Herald.