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LIBERATE Trial in COVID-19 (LIBERATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334629
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Guy's & St Thomas NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

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.

Condition or disease Intervention/treatment Phase
Coronavirus Respiratory Distress Syndrome SARS-CoV Infection Drug: Ibuprofen Phase 4

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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
Estimated Study Start Date : May 26, 2020
Estimated Primary Completion Date : September 25, 2020
Estimated Study Completion Date : May 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




Primary Outcome Measures :
  1. Disease progression [ Time Frame: 14 days ]
    Worsening respiratory failure; defined using severity of hypoxaemia using [PaO2/FiO2 ratio OR SpO2/FiO2 ratio]

  2. Time to mechanical ventilation [ Time Frame: 14 days ]
    Time to mechanical ventilation (or need of)


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 28 days ]
  2. Reduction in proportion of patients who require ventilation [ Time Frame: 28 days ]
  3. Reduction in length of Critical Care stay [ Time Frame: 28 days ]
  4. Reduction in length of Hospital stay [ Time Frame: 28 days ]
  5. Modulation of serum pro- and anti-inflammatory cytokines [ Time Frame: 28 days ]
  6. Reduction in duration of ventilation [ Time Frame: 28 days ]
  7. Increase in ventilator-free days [ Time Frame: 28 days ]


Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Ndaba Mazibuko, MD 02078485452 ndaba.mazibuko@nhs.net
Contact: Chloe Farrell, PhD 02078485452 chloe.farrell@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Chloe Farrell, PhD    02078485452    chloe.farrell@kcl.ac.uk   
Sponsors and Collaborators
King's College London
Guy's & St Thomas NHS Foundation Trust
Investigators
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Principal Investigator: Richard Beale, MD Guy's and St Thomas' NHS Foundation Trust
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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: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus 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