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Study withdrawn.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | No Intervention | ||
| Standard of care plus lipid ibuprofen | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug | Lipid ibuprofen 200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 28 days | |
| Reduction in proportion of patients who require ventilation | 28 days | |
| Reduction in length of Critical Care stay |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Beale, MD | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D012128 | Respiratory Distress Syndrome |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| 28 days |
| Reduction in length of Hospital stay | 28 days |
| Modulation of serum pro- and anti-inflammatory cytokines | 28 days |
| Reduction in duration of ventilation | 28 days |
| Increase in ventilator-free days | 28 days |
| D007239 |
| Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012141 | Respiratory Tract Infections |