LIBERATE Trial in COVID-19 (LIBERATE)
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ClinicalTrials.gov Identifier: NCT04334629 |
Recruitment Status :
Recruiting
First Posted : April 6, 2020
Last Update Posted : October 23, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronavirus Respiratory Distress Syndrome SARS-CoV Infection | Drug: Ibuprofen | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 230 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial |
Actual Study Start Date : | May 26, 2020 |
Estimated Primary Completion Date : | May 25, 2021 |
Estimated Study Completion Date : | September 25, 2021 |

Arm | Intervention/treatment |
---|---|
No Intervention: Standard of care | |
Experimental: Standard of care plus lipid ibuprofen |
Drug: Ibuprofen
Lipid ibuprofen 200 mg
Other Name: Flarin |
- Disease progression [ Time Frame: 14 days ]Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]
- Time to mechanical ventilation [ Time Frame: 14 days ]Time to mechanical ventilation (or need of)
- Overall survival [ Time Frame: 28 days ]
- Reduction in proportion of patients who require ventilation [ Time Frame: 28 days ]
- Reduction in length of Critical Care stay [ Time Frame: 28 days ]
- Reduction in length of Hospital stay [ Time Frame: 28 days ]
- Modulation of serum pro- and anti-inflammatory cytokines [ Time Frame: 28 days ]
- Reduction in duration of ventilation [ Time Frame: 28 days ]
- Increase in ventilator-free days [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334629
Contact: Ndaba Mazibuko, MD | 02078485452 | ndaba.mazibuko@nhs.net | |
Contact: Chloe Farrell, PhD | 02078485452 | chloe.farrell@kcl.ac.uk |
United Kingdom | |
Guy's and St Thomas' NHS Foundation Trust | Recruiting |
London, United Kingdom | |
Contact: Chloe Farrell, PhD 02078485452 chloe.farrell@kcl.ac.uk |
Principal Investigator: | Richard Beale, MD | Guy's and St Thomas' NHS Foundation Trust |
Responsible Party: | King's College London |
ClinicalTrials.gov Identifier: | NCT04334629 |
Other Study ID Numbers: |
282009 |
First Posted: | April 6, 2020 Key Record Dates |
Last Update Posted: | October 23, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Coronaviridae Infections Nidovirales Infections RNA Virus Infections Virus Diseases Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases |
Respiratory Tract Infections Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |