WithdrawnPhase 4

LIBERATE Trial in COVID-19

Stopped: Study withdrawn.

United Kingdom0Started 2020-05-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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:
✕. 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.

What they're measuring

Disease progression

Timeframe: 14 days

Time to mechanical ventilation

Timeframe: 14 days

Trial details

NCT IDNCT04334629

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-25

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