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    Summary
    EudraCT Number:2020-001203-16
    Sponsor's Protocol Code Number:LIBERATE
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-04-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2020-001203-16
    A.3Full title of the trial
    Lipid ibuprofen versus standard of care for acute hypoxaemic respiratory
    failure due to COVID-19: a multicentre, randomised, controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ibuprofen for the treatment of COVID-19
    A.3.2Name or abbreviated title of the trial where available
    LIBERATE
    A.4.1Sponsor's protocol code numberLIBERATE
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGuy's and St Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKing's Together COVID-19 Rapid Research Fund
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointProfessor Richard Beale
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Adult Critical Care Medicine, St. Thomas' Hospital, Westminster Bridge Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402071883038
    B.5.6E-mailrichard.beale@gstt.nhs.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportKing's Together COVID-19 Rapid Research Fund
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointProfessor Richard Beale
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Adult Critical Care Medicine, St Thomas' Hospital, Westminster Bridge Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402071883038
    B.5.6E-mailrichard.beale@gstt.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Flarin
    D.2.1.1.2Name of the Marketing Authorisation holderinfirst Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFlarin
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19; respiratory failure; hypoxaemia.
    E.1.1.1Medical condition in easily understood language
    Coronavirus; breathing difficulties
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001053
    E.1.2Term Acute respiratory failure
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021141
    E.1.2Term Hypoxaemia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1) disease progression prior to Day 14 (worsening respiratory failure;
    defined using severity of hypoxaemia using [PaO2/FiO2 ratio] OR
    [SpO2/FiO2 ratio]);
    (2) time to mechanical ventilation prior to Day 14 (or need of).
    E.2.2Secondary objectives of the trial
    (1) Overall survival [up to 28 days after randomisation]
    (2) Reduction in proportion of patients who require ventilation [to Day
    28]
    (3) Reduction in length of Critical Care stay [to Day 28]
    (4) Reduction in length of Hospital stay [to Day 28]
    (5) Modulation of serum pro- and anti-inflammatory cytokines
    (6) Reduction in duration of ventilation [to Day 28]
    (7) Increase in ventilator-free days (VFDs) [to Day 28]
    *The co-primary outcomes will also be repeated as a secondary analysis
    at Day 28
    E.2.3Trial contains a sub-study No
    E.3Principal 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) ≥ 3 in a single parameter or
    NEWS2 > 5 overall;
    5. Acute hypoxaemic respiratory failure: PaO2/FiO2 ratio ≤ 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.
    E.4Principal 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, defined as Class C (> 9) on the
    Child-Pugh Classification;
    - Patients with acute renal failure, defined as ≥ Stage 2 as per the AKIN
    Criteria;
    - Patients with severe heart failure, defined using the 2018 criteria of
    Advanced Chronic Heart Failure from the Heart Failure Association (HFA)
    of the European Society of Cardiology (ESC).
    - Patients with uncontrolled hypertension.
    2. Known use of any other investigational drug 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.
    E.5 End points
    E.5.1Primary end point(s)
    (1) Disease progression prior to Day 14 (worsening respiratory failure –
    defined using severity of hypoxaemia using [PaO2/FiO2 ratio] OR
    [SpO2/FiO2 ratio]);
    (2) Time to mechanical ventilation prior to Day 14 (or need of).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    (1) Overall survival [up to 28 days after randomisation]
    (2) Reduction in proportion of patients who require ventilation [to Day
    28]
    (3) Reduction in length of Critical Care stay [to Day 28]
    (4) Reduction in length of Hospital stay [to Day 28]
    (5) Modulation in serum pro- and anti-inflammatory cytokines
    (6) Reduction in duration of ventilation [to Day 28]
    (7) Increase in ventilator-free days (VFDs) [to Day 28]
    *The co-primary outcomes will also be repeated as a secondary analysis
    at Day 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be defined as database lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 230
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Regarding F.3.3.1, details are provided in section 6.2 of the clinical
    trial protocol.
    Regarding F.3.3.6, details are provided in section 6.4 of the clinical
    trial protocol.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state230
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    It would not be appropriate for participants to continue to receive the study treatment at the doses outlined in the protocol after the end of the trial as it is designed as an acute treatment for an acute condition. However, it is worth highlighting that the treatment is an over-the-counter (OTC) drug that is available in numerous local pharmacies, high-street pharmacies and online so participants will be able to procure it, for its intended purposes, after the trial, if appropriate.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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