The antioxidant treatment developed by Professor Clive May and Dr Yugeesh Lankadeva at The Florey in Melbourne, Australia, has been many years in the making.
In a new study published Critical Care Medicine, the researchers outline how the regime shows potential as a highly effective treatment for sepsis – a life-threatening response to an underlying infection which can lead to multi-organ failure and death.
Sepsis is the main cause of death in intensive care units and responsible for 11 million deaths worldwide each year. There are no treatments available that reverse the effects of sepsis.
“We started trialling intravenous delivery of a mega-dose of sodium ascorbate, the sodium salt of vitamin C, in a large animal study earlier this year and the results were quite remarkable,” said Professor Clive May.
“We observed a rapid improvement in the clinical state and in measures including reduced temperature and improved heart, kidney, lung and liver function, with no adverse effects. Essentially, we were witnessing a reversal of sepsis-induced multi-organ failure,” said Professor May.
Left to right: Dr Yugeesh Lankadeva and Professor Clive May undertook their sepsis investigations at The Florey.
When Professor May, Dr Lankadeva and collaborator Professor Rinaldo Bellomo, Director of Intensive Care Research at Austin Health in Melbourne became aware of growing reports of multi-organ failure in COVID-19 cases they pivoted their efforts to investigate how their newly developed regime may be able to help critically-ill patients with the COVID-19.
“Like most people in the medical research community, we felt an obligation to help in whatever way we can,” explained Dr Yugeesh Lankadeva.
“We had a newly developed treatment regime on our hands which was showing impressive results in reversing multi-organ failure in another clinically-challenging area, sepsis-induced multi-organ failure. We thought that if there was a chance it could also be used to keep COVID-19 patients alive until a vaccine is found then we have to try,” Dr Lankadeva added.
The team worked swiftly to accelerate a treatment protocol for use in humans.
In April, the regime was approved to compassionately treat a critically ill COVID-19 patient receiving intensive care at Austin Health who was ventilated and experiencing hypotension (low blood pressure), acute respiratory distress and acute kidney dysfunction.
“In a short period of time, we saw improved regulation of blood pressure, arterial blood oxygen levels and kidney function. The patient was able to be taken off machine ventilation 12 days after starting sodium ascorbate treatment and discharged from hospital without any complications 22 days later,” said Professor Bellomo.
The research informed the design and commencement of a pilot randomised controlled clinical trial recently commenced at Austin Health to investigate the safety and efficacy of the mega-dose of sodium ascorbate for intensive care patients with septic shock.
During the trial, blood samples will be collected from patients and investigated at the Florey Institute for Neuroscience and Mental Health to assess immune responses and blood vitamin C levels before, during and after treatment with either sodium ascorbate or placebo.
Dr Lankadeva explained, “In our work at the Florey Institute we are now establishing the optimal dose and treatment duration of sodium ascorbate that could be used by clinicians in a hospital intensive care setting as a potential life-saving option for patients with sepsis-induced multi-organ failure.”
“Having the results of our research move into a clinical trial shows that every dollar invested into medical research is vitally important. We’re proud that our efforts have contributed to the fight against sepsis and could not have foreseen that our work, which has been many years in development, could now also be now applied to critically ill patients with COVID-19,” said Professor May.
Left to Right: Dr Yugeesh Lankadeva, Professor Rinaldo Bellomo and Professor Clive May
The study was funded by the National Health and Medical Research Council (NHMRC) and received funding support from the Victorian Government’s Operational Infrastructure support grant. Dr Yugeesh Lankadeva was funded by a National Heart Foundation Future Leader Fellowship.
The study has been published in Critical Care Medicine. The trial can be found on the Australian and New Zealand Clinical Trials Registry: registration number ACTRN1260000651987.
This sepsis research continues to be investigated in a pilot clinical trial. The vitamin C regime is specially formulated for use in hospital intensive care settings and administered under the direction of specialists.
For all media enquiries contact the Florey Media team.
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