Bedside trial of COVID-19 ICU patients helping doctors pinpoint best treatment

Monash University is a major player in global human trials of a suite of repurposed drugs in critically ill patients from intensive care units – in a bid to outsmart pandemics such as COVID-19.

Researchers are recruiting critically ill COVID-19 patients at the bedside in a unique clinical trial, informing doctors around the globe which medications are providing the most effective treatment, and which ones should be ruled out.

After the 2009 swine flu pandemic claimed around 200,000 lives, the REMAP-CAP trial was set up by a group of intensive care specialists to future-proof for pandemics with intense human trials early in an outbreak. The Minderoo Foundation has today provided $2 million in funding to cover costs associated with staff, resources and materials needed to include patients with COVID-19 in the study.

The trial is active at more than 200 sites across 15 countries including Australia, and has already recruited more than 500 ICU patients with suspected or proven COVID-19. That number is expected to grow every day as more patients become ill.

The unique trial allows researchers to rapidly collect and analyse the effectiveness of various treatments being administered to COVID-19 patients admitted to ICU and then use that information to inform critical decisions about how newer patients should be treated.

Eligible patients are randomised to a combination of appropriate therapies including antibiotics, antiviral medications, convalescent plasma, steroid treatments, and immune therapy, while researchers work rapidly to determine which are safest and most effective combination. The aim is to find out the impact that these combinations of therapies have on patient outcomes, including rate of death and length of admission to ICU.

Intensive care clinicians and primary investigators Associate Professor Alistair Nichol and Professor Steve Webb, of Monash University’s School of Public Health and Preventive Medicine, believe the trial will ensure more patients get the best possible treatment as quickly as possible.

“The goal of REMAP-CAP is not to flatten the curve, but bend it, saving lives during the pandemic by finding effective treatments,” Professor Webb said.

“It’s specifically designed for an outbreak like COVID-19 - to rapidly expand into a large-scale global clinical trial that can evaluate multiple therapies being used at the same time. We can then use this information to ensure newer patients are receiving the safest and most effective drugs faster, potentially saving lives. Importantly, we can also rule out less effective or poorly tolerated medications.”

Professor Webb said several components of the trial made it unique and effective.

“It is randomised, not an observational study, so the results will be reliable and available immediately to inform future treatment strategies,” Professor Webb said.

“It’s a complex trial but it is simple at the bedside - the doctors looking after patients can enrol patients into the study. It doesn’t need trial staff to do that, which is important during a pandemic when everyone is stretched.”

Dr Steven Burnell who leads the Minderoo Foundation’s COVID-19 response, said supporting clinical trials such as REMAP-CAP was a key component of Minderoo Foundation’s efforts to combat the virus.

“This trial has the potential to be a game-changer in the fight against the COVID-19 virus. Its ability to evaluate multiple treatment combinations, at the same time, will hopefully limit the strain on our healthcare systems and save lives,” Dr Burnell said.

Australian Red Cross Lifeblood will be collecting convalescent plasma for use in the Australian trial. This treatment involves transfusing antibody-rich plasma into critically ill COVID-19 patients. There is preliminary evidence from overseas studies that suggests this may hasten recovery. Australians who have been fully recovered from a confirmed case of COVID-19 for more than 28 days, and meet existing blood donation criteria should phone 131 495 and mention ‘convalescent plasma’.

The trial involves researchers, ICU clinicians, and specialists in infectious diseases from Australia, the United Kingdom, Ireland, the Netherlands, Germany, the United States, Canada, Saudi Arabia, Singapore, Belgium, and New Zealand. It is funded by the European Commission and medical science bodies in Canada, Australia, New Zealand and Ireland.

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