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

282009

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.

2020-05-26

2021-05-25

2021-09-25

Withdrawn

Early phase I

Inclusion Criteria: 1. Male or female patients aged 18 years and above; 2. Hospitalised; 3. Confirmed or suspected SARS-CoV-2 infection; 4. National Early Warning Score (NEWS2) greater than or equal to 3 in a single parameter or NEWS2 \> 5 overall; 5. Acute hypoxemic respiratory failure: PaO2/FiO2 ratio less than or equal to 300 OR SpO2/FiO2 ratio \< 315 (Kigali Modification) 6. Provision of written informed consent by the patient OR by the patient's Legal Representative OR professional consultee. Exclusion Criteria: 1. 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. 2. Participation in any other investigational drug products less than 30 days prior to study enrolment; 3. Glasgow Coma Score \< 12; 4. Patients who cannot swallow oral capsules; 5. Pregnant or lactating women; 6. 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-07-25