A trial of lipid ibuprofen to reduce the severity and progression of lung injury in patients with SARS-CoV-2 infections has been launched in South London.
The randomised LIBERATE trial is a collaboration between London’s Guy’s & St Thomas’ NHS Foundation Trust, King’s College London and the pharmaceutical organisation, the SEEK Group. It aims to help refine treatment for COVID-19 with an approach that is distinct from vaccines and anti-viral drugs being researched by other groups.
LIBERATE inclusion criteria are:
- age ≥18 years;
- confirmed or suspected SARS-CoV-2 infection;
- National Early Warning Score (NEWS2) ≥3 in a single parameter or NEWS2 >5 overall;
- acute hypoxemic respiratory failure: PaO2/FiO2 ratio ≤300 or SpO2/FiO2 ratio
- written informed consent.
Primary outcome measures are worsening respiratory failure, defined as severity of hypoxaemia (PaO2/FiO2 ratio or SpO2/FiO2 ratio) and time to or need for mechanical ventilation (time frame for both, 14 days).
Secondary outcome measures are:
- overall survival;
- reduction in proportion of patients who require ventilation;
- reduction in length of critical care stay;
- reduction in length of hospital stay;
- modulation of serum pro- and anti-inflammatory cytokines;
- reduction in duration of ventilation; and
- increase in ventilator-free days.
Time frame for secondary outcome measures is 28 days.
Professor Richard Beale, Consultant in Intensive Care Medicine, said: “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.”