A clinical trial for a novel ibuprofen formulation as a treatment for severe acute respiratory distress syndrome (ARDS), a complication of COVID-19, has now launched in the UK.

The LIBERATE trial is a collaboration between London’s Guy’s & St Thomas’ National Health Service (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. However, it 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.

“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,” said Professor Mitul Mehta, Centre for Innovative Therapeutics (C-Fit), National Institute for Health Research (NIHR) Maudsley Biomedical Research Centre (BRC), one organisation funding the research. 

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.

“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,” said lead researcher Professor Richard Beale, Consultant in Intensive Care Medicine. 

Professor Steven Williams, Head of Department of Neuroimaging at the Centre for Neuroimaging Sciences at King’s College London, 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, Chief Executive Officer of the 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.”