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

See Contacts and Locations

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

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

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

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:

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

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

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