Clinical trial NCT04334629: LIBERATE Trial in COVID-19
Official title: Lipid Ibuprofen Versus Standard of Care for Acute Hypoxemic Respiratory Failure Due to COVID-19: a Multicentre, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronavirus
Respiratory Distress Syndrome
SARS-CoV Infection
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Disease progression
timeFrame: 14 days
measure: Time to mechanical ventilation
timeFrame: 14 days
Secondary outcomes:
measure: Overall survival
timeFrame: 28 days
measure: Reduction in proportion of patients who require ventilation
timeFrame: 28 days
measure: Reduction in length of Critical Care stay
timeFrame: 28 days
measure: Reduction in length of Hospital stay
timeFrame: 28 days
measure: Modulation of serum pro- and anti-inflammatory cytokines
timeFrame: 28 days
measure: Reduction in duration of ventilation
timeFrame: 28 days
measure: Increase in ventilator-free days
timeFrame: 28 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Richard Beale, MD
role: PRINCIPAL_INVESTIGATOR
References: