LIBERATE Trial in COVID-19

Phase 4

Withdrawn

• Conditions: Coronavirus; Respiratory Distress Syndrome; SARS-CoV Infection
• Interventions: Drug: Ibuprofen

• Registration Number: NCT04334629
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Status Verified: 2020-05
• Study Start: 2020-05-26
• Primary Completion: 2021-05-25
• Study Completion: 2021-09-25
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care plus lipid ibuprofen	Ibuprofen	-

Primary Outcome Measures

Name	Time	Method
Time to mechanical ventilation	14 days	Time to mechanical ventilation (or need of)
Disease progression	14 days	Worsening respiratory failure; defined using severity of hypoxaemia using \[PaO2/FiO2 ratio OR SpO2/FiO2 ratio\]

Secondary Outcome Measures

Name	Time	Method
Overall survival	28 days
Reduction in proportion of patients who require ventilation	28 days
Reduction in duration of ventilation	28 days
Increase in ventilator-free days	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

Trial Locations

Locations (1)

Guy's and St Thomas' NHS Foundation Trust; 🇬🇧 London, United Kingdom