ABOUT THE STUDY

Liberate is a clinical trial exploring the use of an anti-inflammatory therapeutic drug in reducing COVID-19 related respiratory failure in hospitalised patients. This respiratory decline, referred to as acute respiratory distress syndrome (ARDS), often results in the need for mechanical ventilation in severely ill SARS-CoV-2 infected patients. The candidate drug, or investigational medicinal product (IMP), is an unique, lipid based formulation of ibuprofen, already licensed for use in the UK, and widely used for other conditions. It is an ideal candidate to complement the current national antiviral drug led COVID-19 studies.

Compelling preclinical data describes a significant survival improvement driven by the attenuation of inflammatory cytokine storm in animal models of ARDS. The lipid formulation has demonstrated impressive efficacy at relatively lower doses in comparison to standard ibuprofen. Crucially, the modified biodistribution that underpins this efficacy also appears to lower the risk of ibuprofen associated side effects.

The study will recruit 230 patients into a randomised, controlled trial design in which the IMP will be compared to standard of care treatment.

Further information about the study can be seen on ClinicalTrials.Gov

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TEAM

Professor Richard Beale

Professor Richard Beale 

Chief Investigator

Dr Ben Carter

Dr Ben Carter

Senior Statistician

Dr Sam Douthwaite

Dr Sam Douthwaite

Co-Investigator

Professor Steve Williams

Professor Steve Williams

Co-Investigator

Professor Mitul Mehta

Professor Mitul Mehta

Co-Investigator

Mr Eric Lynch

Mr Eric Lynch

Co-Investigator

Dr Ndaba Mazibuko

Dr Ndaba Mazibuko 

Co-Investigator

Professor Steve Williams

Dr Chloe Farrell

Co-Investigator and Trial Manager

COLLABORATORS AND CONTRIBUTORS

  • Prof Allan Young
  • Prof Matthew Hotopf
  • Prof Peter Sasieni
  • Dr Peter Hawkins
  • Ms Caroline Murphy
  • Dr Luigi Camporota
  • Dr Nicholas Barrett
  • Dr Simon Goldenberg
  • Mr Dominic Stringer
  • Prof Alan Watkins
  • Prof James Watson
  • Ms Oyinda Sogeyinbo
  • King’s College London Centre for Innovative Therapeutics (C-FIT)
  • King’s Clinical Trials Unit
  • King’s Health Partner’s Clinical Trials Office
  • Beta Therapeutics and Diagnostics Health Limited
  • SEEK Group
  • infirst Ltd

OUR SUPPORTERS

This work is supported by

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NIHR Biomedical Research Centre for Mental Health South London and Maudsley NHS

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King’s Together and the King’s Department of Neuroimaging; a fund by King’s College London

The largest NHS trusts in England with a diverse and multicultural populations.

Frequently Asked Questions (FAQs)

About 80% of individuals who contract coronavirus recover without any need for hospitalisation. For those who do require hospitalisation, most do get better, but some patients may need oxygen and/or mechanical ventilation before they do so. However, there is a small percent of people who do not recover. At this time, there are no drugs or treatments of proven value against the coronavirus. This study aims to find out whether the additional of lipid ibuprofen to usual standard of care reduces the progression of respiratory failure in patients with coronavirus infection.

This study aims to find out whether the addition of lipid ibuprofen to usual standard of care reduces the progression of respiratory failure in patients with coronavirus infection. Preliminary research has indicated that lipid ibuprofen might be a useful treatment however nobody knows whether it will turn out to be more effective in helping coronavirus patients recover than the usual standard of care during hospitalisation. Lipid ibuprofen is an over-the-counter medication, typically used to treat inflammation and pain and has a well-established side-effect and safety profile.

The study is being conducted by researchers at King’s College London and Guy’s & St Thomas’ NHS Foundation Trust, who are sponsoring the study.

Patients will be invited to participate in the study if they are at least 18 years of age, have confirmed or suspected coronavirus infection, and are receiving treatment in hospital. Patients will not be included if the attending doctor believes there is a particular reason that the study treatment is unsuitable.

No, it is up to you to decide whether or not to take part. If you do decide to take part, you will be given an information sheet to keep and be asked to sign a consent form. If you have agreed to take part, you are still free to withdraw at any time without giving any reasons and this will not affect the standard of hospital care you receive.

If you decide to take part in the study, you will be asked to sign a consent form. Next, brief details identifying you and understanding your health and any existing medical conditions will be entered into a computer. The computer will then allocate you at random (like flipping a coin) to one of two possible treatment options. One treatment option is that you will receive the usual standard of care at your hospital. The other treatment option is that you will receive the usual standard of care at your hospital plus an additional treatment (800 mg dose of lipid ibuprofen, which contains beef-derived gelatine) which is given by mouth on three separate occasions: (1) at the beginning of the study, (2) 12 hours after the first dose and (3) 24 hours after the first dose. Neither you nor your doctor can choose which option you will be allocated to. Additional information about your health will be recorded and entered into the study computer but no additional visits will be required after you leave the hospital. A small amount of blood taken by the doctors and/or nurses during your hospital stay as part of your standard care will be transferred to a King’s College Hospital research laboratory for further analysis. In some instances, information about your health (both prior to, during and after the study) may be obtained from medical records or databases so that the study team can get more detailed and/or longer-term information about the effects of the treatment on your health.

We do not know if the treatment (lipid ibuprofen) being tested will have any additional benefits. Your study treatment may or may not help you personally, however the hope is that the findings from this study should help future patients.

Apart from the known side effects of lipid ibuprofen (which may include stomach upset, headache, non-specific allergic reactions, asthma, aggravated asthma and/or skin reactions/rashes), there is the unlikely possibility of a severe reaction to the study drug. Please ask your hospital doctor if you would like more information. Your doctor will be aware of any particular side effects that they should look out for.

If you or your doctor want to stop the study treatment before the course has been completed, then you are free to do so. If you decide that you do not wish for any more information to be collected about you, you are free to say so (although de-identified information that has been collected up to that point will continue to be analysed by the research team).

If you have any questions, please speak to your hospital medical team. Further information about the study can also be requested from your study doctor or Dr Ndaba Mazibuko (ndaba.mazibuko@nhs.net) or Dr Chloe Farrell (chloe.farrell@nhs.net).

We will need to use information from you and your medical records for this research project. People will use this information to do the research or check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. All data will comply with the provisions of the Data Protection Act and will only be accessible via written permission from the Chief Investigator of the study.

You can find additional information about how your information is used by:

  • Visiting www.guysandstthomas.nhs.uk/research/patients/use-of-data.aspx or www.kcl.ac.uk/research/support/research-ethics/kings-college-london-statement-on-use-of-personal-data-in-research;
  • Asking one of the research team;
  • Contacting the Data Protection Officer at Guy’s and St Thomas’ NHS Foundation Trust: Nick Murphy-O’Keane (DPO@gstt.nhs.uk).

All trial treatments will be free. Neither you nor your medical staff will be paid for your participation in this study.

This study has been reviewed and given a favourable opinion by the London - Dulwich REC. The study has also been reviewed by the UK Regulatory Authority, the MHRA (the Medicines and Healthcare products Regulatory Agency).