LIBERATE Trial in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-26

Study Completion Date

2021-09-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronavirus Respiratory Distress Syndrome SARS-CoV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard of care plus lipid ibuprofen

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Lipid ibuprofen 200 mg

Interventions

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Ibuprofen

Lipid ibuprofen 200 mg

Intervention Type DRUG

Other Intervention Names

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Flarin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No