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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
Sponsor:
Collaborator:
Guy's & St Thomas NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Tracking Information
First Submitted Date  ICMJE April 2, 2020
First Posted Date  ICMJE April 6, 2020
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE May 26, 2020
Estimated Primary Completion Date May 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LIBERATE Trial in COVID-19
Official Title  ICMJE Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronavirus
  • Respiratory Distress Syndrome
  • SARS-CoV Infection
Intervention  ICMJE Drug: Ibuprofen
Lipid ibuprofen 200 mg
Other Name: Flarin
Study Arms  ICMJE
  • No Intervention: Standard of care
  • Experimental: Standard of care plus lipid ibuprofen
    Intervention: Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2020)
230
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 25, 2021
Estimated Primary Completion Date May 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ndaba Mazibuko, MD 02078485452 ndaba.mazibuko@nhs.net
Contact: Chloe Farrell, PhD 02078485452 chloe.farrell@kcl.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04334629
Other Study ID Numbers  ICMJE 282009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE Guy's & St Thomas NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: Richard Beale, MD Guy's and St Thomas' NHS Foundation Trust
PRS Account King's College London
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP