Status:
WITHDRAWN
LIBERATE Trial in COVID-19
Lead Sponsor:
King's College London
Conditions:
Coronavirus
Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04334629
Start Date
May 26 2020
End Date
September 25 2021
Last Update
July 25 2023
Active Locations (1)
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1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom