LIBERATE Trial in COVID-19

NCT04334629 | Withdrawn Phase 4 DMC

• 1 other identifier: 282009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus; Respiratory Distress Syndrome; SARS-CoV Infection

Outcome Measures

Primary Outcomes (2)

• Disease progression

  Worsening respiratory failure; defined using severity of hypoxaemia using \[PaO2/FiO2 ratio OR SpO2/FiO2 ratio\]

  14 days

• Time to mechanical ventilation

  Time to mechanical ventilation (or need of)

  14 days

Secondary Outcomes (7)

• Overall survival

  28 days

• Reduction in proportion of patients who require ventilation

  28 days

• Reduction in length of Critical Care stay

  28 days

• Reduction in length of Hospital stay

  28 days

• Modulation of serum pro- and anti-inflammatory cytokines

  28 days

Study Arms (2)

Standard of care

NO INTERVENTION

Standard of care plus lipid ibuprofen

EXPERIMENTAL

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

Lipid ibuprofen 200 mg

Also known as: Flarin

Standard of care plus lipid ibuprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Coronavirus Infections; Respiratory Distress Syndrome; Severe Acute Respiratory Syndrome

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Richard Beale, MD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 6, 2020
• Study Start: May 26, 2020
• Primary Completion: May 25, 2021
• Study Completion: September 25, 2021
• Last Updated: July 25, 2023

Record last verified: 2020-05

Locations

GB (1)