LIBERATE Trial in COVID-19

Study Overview
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Brief Summary
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The study aims to evaluate the reduction in severity and progression of lung injury with three doses of lipid ibuprofen in patients with SARS-CoV-2 infections.

Official Title
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Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial

Conditions
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Coronavirus, Respiratory Distress Syndrome, SARS-CoV Infection

Intervention / Treatment
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* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged 18 years and above; Hospitalised; Confirmed or suspected SARS-CoV-2 infection; National Early Warning Score (NEWS2) greater than or equal to 3 in a single parameter or NEWS2 > 5 overall; Acute hypoxemic respiratory failure: PaO2/FiO2 ratio less than or equal to 300 OR SpO2/FiO2 ratio < 315 (Kigali Modification) Provision of written informed consent by the patient OR by the patient's Legal Representative OR professional consultee. Exclusion Criteria: Any of the following contraindications to ibuprofen: A known hypersensitivity to ibuprofen or any other constituent of the medicinal product; Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs; Patients with severe hepatic failure; Patients with acute renal failure; Patients with severe heart failure. Participation in any other investigational drug products less than 30 days prior to study enrolment; Glasgow Coma Score < 12; Patients who cannot swallow oral capsules; Pregnant or lactating women; Any medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of care<br> | |
| Experimental: Standard of care plus lipid ibuprofen<br> | Drug: Ibuprofen<br>* Lipid ibuprofen 200 mg<br>* Other names: Flarin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio] | 14 days | 
| Time to mechanical ventilation | Time to mechanical ventilation (or need of) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 28 days | 
| Reduction in proportion of patients who require ventilation |  | 28 days | 
| Reduction in length of Critical Care stay |  | 28 days | 
| Reduction in length of Hospital stay |  | 28 days | 
| Modulation of serum pro- and anti-inflammatory cytokines |  | 28 days | 
| Reduction in duration of ventilation |  | 28 days | 
| Increase in ventilator-free days |  | 28 days |