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A Randomised, Double-blind, Placebo Controlled Study of Eicosapentaenoic Acid (EPA-FFA) Gastro-resistant Capsules to Treat Hospitalised Subjects With Confirmed SARS-CoV-2

Trial Profile

A Randomised, Double-blind, Placebo Controlled Study of Eicosapentaenoic Acid (EPA-FFA) Gastro-resistant Capsules to Treat Hospitalised Subjects With Confirmed SARS-CoV-2

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2020

At a glance

  • Drugs Eicosapentaenoic acid (Primary)
  • Indications COVID-19 pneumonia
  • Focus Registrational; Therapeutic Use
  • Sponsors SLA Pharma
  • Most Recent Events

    • 22 Nov 2020 Status changed from not yet recruiting to recruiting.
    • 29 Oct 2020 Number of arms changed from 1 to 2. Placebo Comparator arm added. Study design changed from Single Group Assignment to Parallel Assignment. Masking changed from open label to double blind. Allocation changed to Randomized. Eligibility criteria amended to subjects from 18 years and above. Planned number of patients also increased.
    • 29 Oct 2020 Planned number of patients changed from 240 to 284.

Trial Overview

Purpose

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

Primary Endpoints

Evaluation of EPA-FFA efficacy compared to placebo

description: Time to treatment failure during the 28-day treatment period. Treatment failure is defined as additional or alternative treatment required, or intubation and invasive ventilation, or transfer to intensive care unit, or death.
time_frame: 28 days

Other Endpoints

Time to and amount of clinical improvement

description: To determine whether EPA-FFA gastro-resistant capsules decreases the time to and amount of clinical improvement as determined by the WHO 9-point ordinal scale during the study.
time_frame: 28 days

Change in recovery and survival rate

description: To determine whether EPA-FFA gastro-resistant capsules increases the number of subjects alive and discharged home without supplemental oxygen therapy.
time_frame: 28 days

Reduction of CRP and IL-6

description: To determine whether EPA-FFA gastro-resistant capsules decreases CRP and IL-6 during the study.
time_frame: 28 days

Increase in IFN-γ

description: To determine whether EPA-FFA gastro-resistant capsules increases IFN-γ during the study
time_frame: 28 days

Reduction in proinflammatory chemokines and cytokines.

description: To determine whether EPA-FFA gastro-resistant capsules decreases other proinflammatory chemokines and cytokines.
time_frame: 28 days

Safety - Vitals, AEs and Clinical lab parameters

description: To evaluate the safety of EPA-FFA gastro-resistant capsules in the treatment of COVID-19 (SARS-CoV-2) by assessing subjects clinical lab parameters and vital signs, and the number and proportion of subjects with AEs.
time_frame: throughout the study, about 3 months [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID-19 pneumonia treatment moderate, severe

Subjects

  • Subject Type patients
  • Number

    Planned: 284

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient 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.

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04335032 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001396-33 European Clinical Trials Database
EPA-COV001 -

Organisations

  • Sponsors SLA Pharma
  • Affiliations SLA Pharma

Trial Dates

  • Initiation Dates

    Planned : 09 Nov 2020

    Actual : 13 Nov 2020

  • Primary Completion Dates

    Planned : 13 Jul 2021

  • End Dates

    Planned : 31 Jul 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase III
  • Location France; Ireland; Israel; South Africa; Spain; United Kingdom; USA
  • Focus Registrational; Therapeutic Use

Interventions

Drugs Route Formulation
Eicosapentaenoic acidPrimary Drug Oral Capsule

Eicosapentaenoic acid gastro-resistant capsules

Eicosapentaenoic acid free fatty acid (EPA-FFA) 500mg gastro-resistant capsules 2g daily (two capsules twice daily). One capsule of EPA-FFA gastro-resistant capsules contains 500mg EPA-FFA in a capsule containing gelatin, glycerol, sorbitol, titanium dioxide, FD&C blue No. 1, hypromellose phthalate, dibutyl sebacate. Drug: Eicosapentaenoic acid gastro-resistant capsules (same as in arm/group description) Other Name: Alfa

Placebo

Placebo capsules that cannot be visually differentiated from the active treatment Drug: Placebo (same as in arm/group description)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Justin Slagel
01923681001
jslagel@slapharma.com
show details
, S.L.A. Pharma AG
-

Centres

Centre Name Location Trial Centre Country
-
-
-
S.L.A. Pharma AG
-
-

Trial History

Event Date Event Type Comment
25 Nov 2020 Other trial event New source identified and integrated (European Clinical Trials Database: EudraCT2020-001396-33). Updated 25 Nov 2020
22 Nov 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 25 Nov 2020
03 Nov 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 03 Nov 2020
29 Oct 2020 Protocol amendment Number of arms changed from 1 to 2. Placebo Comparator arm added. Study design changed from Single Group Assignment to Parallel Assignment. Masking changed from open label to double blind. Allocation changed to Randomized. Eligibility criteria amended to subjects from 18 years and above. Planned number of patients also increased. Updated 03 Nov 2020
29 Oct 2020 Other trial event Planned number of patients changed from 240 to 284. Updated 03 Nov 2020
29 Oct 2020 Completion date Planned End Date changed from 31 Jul 2020 to 31 Jul 2021. Updated 03 Nov 2020
29 Oct 2020 Other trial event Planned primary completion date changed from 13 Jul 2020 to 13 Jul 2021. Updated 03 Nov 2020
29 Oct 2020 Other trial event Planned initiation date changed from 13 Apr 2020 to 9 Nov 2020. Updated 03 Nov 2020
13 Apr 2020 Other trial event According to a SLA Pharma media release, The MHRA in the UK has approved the trial and late-stage discussions are ongoing with authorities in other European countries. Additionally, an application has been submitted to the FDA in the US. It is expected that the first patients in the trial will be enrolled shortly and additional hospital sites are being recruited for the trial. Updated 17 Apr 2020
09 Apr 2020 Other trial event Planned number of patients changed from 150 to 240. Updated 14 Apr 2020
07 Apr 2020 New trial record New trial record Updated 07 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  3. SLA Pharma. KD Pharma Group & SLA Pharma Initiate Clinical Trial For COVID-19. Media-Rel 2020;.

    Media Release
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