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A Randomized Controlled Study of Eicosapentaenoic Acid (EPA-FFA) Gastro-resistant Capsules to Treat Hospitalized Subjects With Confirmed SARS-CoV-2

Trial Profile

A Randomized Controlled Study of Eicosapentaenoic Acid (EPA-FFA) Gastro-resistant Capsules to Treat Hospitalized Subjects With Confirmed SARS-CoV-2

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2020

At a glance

  • Drugs Eicosapentaenoic acid (Primary)
  • Indications COVID 2019 infections; Pneumonia
  • Focus Registrational; Therapeutic Use
  • Sponsors SLA Pharma
  • Most Recent Events

    • 13 Apr 2020 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.
    • 09 Apr 2020 Planned number of patients changed from 150 to 240.
    • 07 Apr 2020 New trial record

Trial Overview

Purpose

This is an open-label, randomized, controlled study in hospitalized subjects with confirmed SARS-CoV-2.

Primary Endpoints

Efficacy of EPA-FFA

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

Increase in oxygen saturation

description: Time to (in days) and number of days with oxygen saturation >95% without oxygen inhalation during the 28-day treatment period
time_frame: 28 days

PaO2/FiO2 >300mmHg increase

description: Time to (in days) and number of days with PaO2/FiO2 >300mmHg without oxygen inhalation during the 28-day treatment period
time_frame: 28 days

Reduction of IL-6

description: Change in IL-6 level during the 28-day treatment period
time_frame: 28 days

Mortality rate reduction

description: To determine whether EPA-FFA gastro-resistant capsules decreases mortality rate during the study.
time_frame: throughout the study, about 3 months

Reduction in ICU stays

description: To determine whether EPA-FFA gastro-resistant capsules decreases ICU days during the study.
time_frame: throughout the study, about 3 months

Reducing hospitalisation days

description: To determine whether EPA-FFA gastro-resistant capsules decreases hospitalisation days during the study
time_frame: throughout the study, about 3 months

reduction in need for mechanical ventilation

description: To determine whether EPA-FFA gastro-resistant capsules decreases the need for invasive mechanical ventilation during the study
time_frame: throughout the study, about 3 months

Fever reduction

description: Time to (in days) and number of days with fever normalization < 36.6°C armpit, < 37.2°C oral, < 37.8°C rectal, during the 28-day treatment period
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 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 240

  • Sex male & female
  • Age Group 18-85 years; adult; elderly

Patient Inclusion Criteria

The subject must satisfy the following criteria for entry into the study: 1. Male or female, aged 18 to 85 years. 2. Provided informed consent prior to any study specific procedure being conducted. 3. Virological or sereological diagnosis of SARS-CoV-2. 4. Evidence of viral pneumonia (either CT scan or Chest Ultrasonogram). 5. Oxygen saturation at rest in ambient air ≤ 94%. 6. PaO2/FiO2 <300mmHg without oxygen inhalation 7. Fever defined as temperature ≥ 36.6°C armpit, ≥ 37.2°C oral, ≥ 37.8°C rectal.

Patient Exclusion Criteria

The subject will be excluded from the study if any of the following applies: 1. Subjects intubated prior to administration of IMP. 2. Subjects requiring mechanical ventilation at screening. 3. Subjects who are unable to swallow capsules easily. 4. Known allergic reaction or intolerant to fish or fish oils. 5. Known allergic reaction to excipients of IMP. 6. Subjects who are pregnant or breast-feeding at screening. 7. Subjects who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. 8. Subjects taking warfarin or other anti-coagulants. 9. Subjects taking immunomodulators/immunosuppressants (including corticosteroids) 10. Subjects who have used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to Screening. 11. Subjects who are participating in other clinical studies at the same time. 12. Evidence of multi-organ failure. 13. Subjects with a do not resuscitate code. 14. Subject is deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. 15. Subject is deemed, by the investigator, likely to require transfer to the intensive care unit (ICU) or unlikely to survive for at least 48 hours. 16. Subjects with any laboratory tests from samples taken at screening considered clinically significant.

Trial Details

Identifiers

Identifier Owner
NCT04335032 ClinicalTrials.gov: US National Institutes of Health
EPA-COV001 -

Organisations

  • Sponsors SLA Pharma
  • Affiliations SLA Pharma

Trial Dates

  • Initiation Dates

    Planned : 13 Apr 2020

  • Primary Completion Dates

    Planned : 13 Jul 2020

  • End Dates

    Planned : 31 Jul 2020

Other Details

  • Design multicentre; open; prospective; randomised
  • Phase of Trial Phase III
  • Location 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

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
27 Apr 2020 Other trial event Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 27 Apr 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. SLA Pharma. KD Pharma Group & SLA Pharma Initiate Clinical Trial For COVID-19. Media-Rel 2020;.

    Media Release
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