LIBERATE Trial in COVID-19

Coronavirus Clinical Trial

— LIBERATE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04334629
• Other study ID #: 282009
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 26, 2020
• Est. completion date: September 25, 2021

Study information

• Verified date: May 2020
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• SARS-CoV Infection
• Severe Acute Respiratory Syndrome

Intervention

Drug:
• Ibuprofen
Lipid ibuprofen 200 mg

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease progression	Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]	14 days
Primary	Time to mechanical ventilation	Time to mechanical ventilation (or need of)	14 days
Secondary	Overall survival		28 days
Secondary	Reduction in proportion of patients who require ventilation		28 days
Secondary	Reduction in length of Critical Care stay		28 days
Secondary	Reduction in length of Hospital stay		28 days
Secondary	Modulation of serum pro- and anti-inflammatory cytokines		28 days
Secondary	Reduction in duration of ventilation		28 days
Secondary	Increase in ventilator-free days		28 days