EPA-FFA to Treat Hospitalised Patients With COVID-19 (SARS-CoV-2)

• Status: Not yet recruiting
• Trial end date: 2021-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an double-blind, randomized, placebo controlled phase III study in hospitalized subjects with confirmed SARS-CoV-2.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S.L.A. Pharma AG

Criteria

Inclusion criteria:

The subject must satisfy the following criteria for entry into the study:

1. Male or female, aged 18 years and above.

2. Provide informed consent prior to any study specific procedure being conducted; for older patients who lack mental or physical capacity, next of kin or legal guardians will be allowed to provide consent on their behalf. This consent can be obtained remotely by telephone to the next of kin, or by a doctor with relevant experience in COVID-19 disease not directly involved in the study acting as the patient's advocate and then subsequently informing the next of kin (eg by a telephone call also offering them an opportunity to review and agree the ICF with them; the patient may then continue in the study or withdraw at a later date if the next of kin subsequently decides to withdraw consent).

3. Positive local approved test to confirm diagnosis of SARS-CoV-2 within 7 days prior to baseline.

4. Classified as moderate or severe based on the modified WHO/NIH baseline severity criteria. Moderate: evidence of lower respiratory disease by clinical assessment (e.g. signs or symptoms of lung infection) or by chest X-ray/CT/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (SaO2) ≥ 94% on room air at sea level. Severe: respiratory frequency >30 bpm, SaO2 < 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg, or lung infiltrates >50%.

5. Hospitalised or attended the hospital ED due to clinical and/or virological diagnosis of SARS-CoV-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a COVID-19 hospital OP clinic as clinically indicated at the investigator's discretion. Where it is not possible for the subject to attend a hospital OP clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and SaO2 assessments and blood tests, subsequent assessments post-hospitalisation or ED visit may be conducted at the subject's home.

Exclusion criteria:

The subject will be excluded from the study if any of the following applies:

1. No symptoms or signs or lung imaging abnormalities of SARS-CoV-2.

2. On or clinically diagnosed as requiring intubation at screening.

3. On or clinically diagnosed as requiring mechanical ventilation at screening.

4. On or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5).

5. On or clinically diagnosed as requiring noninvasive positive pressure ventilation.

6. On or clinically diagnosed as requiring extracorporeal membrane oxygenation (ECMO).

7. Unable to swallow study capsules easily.

8. Known allergic reaction or intolerant to fish or fish oils.

9. Known allergic reaction to excipients of IMP.

10. Pregnant or breast-feeding at screening.

11. Taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study.

12. Taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study.

13. Used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to Screening.

14. Participating in other clinical studies at the same time.

15. Evidence of multi-organ failure, SOFA score > 9.

16. Deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol.

17. Deemed, by the investigator, likely to require transfer to the intensive care unit (ICU) or unlikely to survive for at least 48 hours.

18. Any gastro-intestinal symptoms at screening considered clinically significant.

19. Clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.