Last updated: November 26, 2021
Sponsor: S.L.A. Pharma AG
Overall Status: Active - Recruiting
Phase
3
Condition
Covid-19
Sars-cov-2
Treatment
N/AClinical Study ID
NCT04335032
EPA-COV-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria: The subject must satisfy the following criteria for entry into the study:
- Male or female, aged 18 years and above.
- Provide informed consent prior to any study specific procedure being conducted; forolder patients who lack mental or physical capacity, next of kin or legal guardianswill be allowed to provide consent on their behalf. This consent can be obtainedremotely by telephone to the next of kin, or by a doctor with relevant experience inCOVID-19 disease not directly involved in the study acting as the patient's advocateand then subsequently informing the next of kin (eg by a telephone call also offeringthem an opportunity to review and agree the ICF with them; the patient may thencontinue in the study or withdraw at a later date if the next of kin subsequentlydecides to withdraw consent).
- Positive local approved test to confirm diagnosis of SARS-CoV-2 within 7 days prior tobaseline.
- Classified as moderate or severe based on the modified WHO/NIH baseline severitycriteria. 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 airat sea level. Severe: respiratory frequency >30 bpm, SaO2 < 94% on room air at sealevel, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg, or lung infiltrates >50%.
- Hospitalised or attended the hospital ED due to clinical and/or virological diagnosisof 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 theinvestigator's discretion. Where it is not possible for the subject to attend ahospital OP clinic, then providing a suitably trained healthcare professional (eg partof the clinical research team) as directed by the investigator, is available to visitthe subject at home to conduct the necessary clinical and SaO2 assessments and bloodtests, subsequent assessments post-hospitalisation or ED visit may be conducted at thesubject's home.
Exclusion
Exclusion criteria: The subject will be excluded from the study if any of the following applies:
- No symptoms or signs or lung imaging abnormalities of SARS-CoV-2.
- On or clinically diagnosed as requiring intubation at screening.
- On or clinically diagnosed as requiring mechanical ventilation at screening.
- On or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20L/min with fraction of delivered oxygen ≥ 0.5).
- On or clinically diagnosed as requiring noninvasive positive pressure ventilation.
- On or clinically diagnosed as requiring extracorporeal membrane oxygenation (ECMO).
- Unable to swallow study capsules easily.
- Known allergic reaction or intolerant to fish or fish oils.
- Known allergic reaction to excipients of IMP.
- Pregnant or breast-feeding at screening.
- Taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop themfor the duration of the study.
- Taking immunomodulators/immunosuppressants, including corticosteroids on entry intothe study.
- Used another investigational drug in the past 48 hours or 5 half-lives, whichever islonger, prior to Screening.
- Participating in other clinical studies at the same time.
- Evidence of multi-organ failure, SOFA score > 9.
- Deemed, by the investigator, unlikely to be able to comply with the requirements ofthe protocol.
- Deemed, by the investigator, likely to require transfer to the intensive care unit (ICU) or unlikely to survive for at least 48 hours.
- Any gastro-intestinal symptoms at screening considered clinically significant.
- Clinically significant abnormalities, which in the opinion of the investigator wouldsignificantly risk the safety of the subject or the main objectives of the study.
Study Design
Total Participants: 284
Study Start date:
January 08, 2021
Estimated Completion Date:
December 01, 2021
Study Description
Connect with a study center
Hospital Universitario Vall d'Hebron
Barcelona, 119 129
SpainActive - Recruiting
Hull
Cottingham, HU16 5JQ
United KingdomActive - Recruiting
UHCW
Coventry, CV2 2DX
United KingdomActive - Recruiting
NPH
Harrow, HA1 3UJ
United KingdomActive - Recruiting
Rotherham NHS Foundation Trust
Rotherham, S60 2UD
United KingdomActive - Recruiting
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