LIBERATE Trial in COVID-19

King's College London

Status and phase: Withdrawn; Phase 4

Conditions: Respiratory Distress Syndrome; SARS-CoV Infection; Coronavirus

Treatments: Drug: Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT04334629

282009

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Standard of care

No Intervention group

Standard of care plus lipid ibuprofen

Experimental group

Treatment:

Drug: Ibuprofen