Coronavirus, Respiratory Distress Syndrome, SARS-CoV Infection
Conditions
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.
Interventions
DRUGIbuprofen
Lipid ibuprofen 200 mg
Sponsors
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression | 14 days | Worsening respiratory failure; defined using severity of hypoxaemia using \[PaO2/FiO2 ratio OR SpO2/FiO2 ratio\] |
| Time to mechanical ventilation | 14 days | Time to mechanical ventilation (or need of) |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in proportion of patients who require ventilation | 28 days |
| Reduction in length of Critical Care stay | 28 days |
| Increase in ventilator-free days | 28 days |
| Modulation of serum pro- and anti-inflammatory cytokines | 28 days |
| Reduction in duration of ventilation | 28 days |
| Reduction in length of Hospital stay | 28 days |
| Overall survival | 28 days |
Countries
United Kingdom
Outcome results
None listed