Back to resultsLIBERATE Trial in COVID-19 (LIBERATE)
Primary Purpose
Coronavirus, Respiratory Distress Syndrome, SARS-CoV Infection
Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Coronavirus
Eligibility Criteria
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.
Sites / Locations
- Guy's and St Thomas' NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of care
Standard of care plus lipid ibuprofen
Arm Description
Outcomes
Primary Outcome Measures
Disease progression
Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]
Time to mechanical ventilation
Time to mechanical ventilation (or need of)
Secondary Outcome Measures
Overall survival
Reduction in proportion of patients who require ventilation
Reduction in length of Critical Care stay
Reduction in length of Hospital stay
Modulation of serum pro- and anti-inflammatory cytokines
Reduction in duration of ventilation
Increase in ventilator-free days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04334629
Brief Title
LIBERATE Trial in COVID-19
Acronym
LIBERATE
Official Title
Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study withdrawn.
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
September 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Respiratory Distress Syndrome, SARS-CoV Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
No Intervention
Arm Title
Standard of care plus lipid ibuprofen
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Flarin
Intervention Description
Lipid ibuprofen 200 mg
Primary Outcome Measure Information:
Title
Disease progression
Description
Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]
Time Frame
14 days
Title
Time to mechanical ventilation
Description
Time to mechanical ventilation (or need of)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
28 days
Title
Reduction in proportion of patients who require ventilation
Time Frame
28 days
Title
Reduction in length of Critical Care stay
Time Frame
28 days
Title
Reduction in length of Hospital stay
Time Frame
28 days
Title
Modulation of serum pro- and anti-inflammatory cytokines
Time Frame
28 days
Title
Reduction in duration of ventilation
Time Frame
28 days
Title
Increase in ventilator-free days
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Beale, MD
Organizational Affiliation
Guy's and St Thomas' NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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LIBERATE Trial in COVID-19
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