Trial testing a unique formulation of ibuprofen to treat COVID-19 launches

A trial of a unique formulation of ibuprofen treatment for treating severe acute respiratory distress syndrome (ARDS), a complication of COVID-19, has launched in south London.

The LIBERATE trial is a pioneering collaboration between Guy’s and St Thomas’ NHS Foundation Trust, King’s College London and the pharmaceutical organisation the SEEK Group.

The study aims to reduce respiratory failure with COVID-19, which may decrease the need for more aggressive intervention such as ventilation, and decrease the length of hospital stay. The leaders of the study say that this trial will help to refine treatment for COVID-19, as an approach distinct from either vaccines or anti-viral drugs being researched by other groups.

The drug is a unique formulation of ibuprofen that is already licensed for use in the UK, and is widely used for other conditions. The drug differs from standard ibuprofen. In lab-based experiments performed by the SEEK Group the drug was shown to be more effective than standard ibuprofen for treating ARDS.

The LIBERATE trial will be a randomised study, with half of the recruited patients receiving standard care and the other half receiving the drug in addition to standard care. The drug will be administered at a very specific stage of the disease, to hospitalised patients with confirmed or suspected COVID-19.

LIBERATE is being led at Guy’s and St Thomas’ NHS Foundation Trust by Prof Richard Beale, consultant in intensive care medicine who says:

As a new illness, there are limited treatment options for patients with COVID-19. The clinical trial will assess whether this unique formulation of an established drug benefits patients with COVID-19.

Prof Mitul Mehta, Centre for Innovative Therapeutics (C-FIT), National Institute for Health Research South London (NIHR) and Maudsley Biomedical Research Centre (BRC), said, 

This trial represents an opportunity to formally test promising results from animal models and case studies in patients. If successful this trial will provide evidence for a low cost treatment that could benefit patients in the UK as well as other countries, including lower and middle income countries.

Prof Matthew Hotopf, Director of the NIHR South London and Maudsley NHS Foundation Trust BRC, said:

This highly innovative therapeutic approach seeks to rapidly advance a potentially important new treatment. If successful, the global public health value of this trial result would be immense given the low cost and availability of this medicine. The World Health Organisation and European Medicines Agency have highlighted that studies like this are vital in tackling this pandemic.

Prof Steven Williams, Head of Department of Neuroimaging at the Centre for Institute of Psychiatry, Psychology and Neurosciences, said:

Since SEEK shared their compelling pre-clinical data with us a few weeks ago, the C-FIT team have worked tirelessly to design and initiate this critical trial. We will now persevere with its implementation and delivery.

Gregory Stoloff, CEO of SEEK Group, said:

SEEK’s objective has always been to bring medicines to patients as quickly as possible with safety, efficacy and affordability as key priorities using innovative and pioneering techniques. This joint venture provides SEEK with access to world renowned research and to the leading experts in these therapeutic areas of unmet need. It would be wonderful to be able to save lives and improve the environment and restrictions associated with this COVID-19 pandemic.

This trial has been facilitated by King’s College London’s C-FIT and a newly formed joint venture for repurposing medicines with King’s College London and SEEK - Beta Therapeutics and Diagnostics Health Limited.

The research is funded by King’s College London’s King’s Together Fund, the NIHR South London and Maudsley NHS Foundation Trust BRC and King’s College London Department of Neuroimaging.

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