LIBERATE Trial in COVID-19

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.