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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335032
Recruitment Status : Not yet recruiting
First Posted : April 6, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
S.L.A. Pharma AG

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

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Drug: Eicosapentaenoic acid gastro-resistant capsules Phase 3

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Eicosapentaenoic Acid (EPA-FFA) Gastro-resistant Capsules to Treat Hospitalized Subjects With Confirmed SARS-CoV-2
Estimated Study Start Date : April 13, 2020
Estimated Primary Completion Date : July 13, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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




Primary Outcome Measures :
  1. Evaluation of EPA-FFA efficacy compared to standard of care [ Time Frame: 28 days ]
    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.


Secondary Outcome Measures :
  1. Increase in oxygen saturation [ Time Frame: 28 days ]
    Time to (in days) and number of days with oxygen saturation >95% without oxygen inhalation during the 28-day treatment period

  2. PaO2/FiO2 >300mmHg increase [ Time Frame: 28 days ]
    Time to (in days) and number of days with PaO2/FiO2 >300mmHg without oxygen inhalation during the 28-day treatment period

  3. Reduction of IL-6 [ Time Frame: 28 days ]
    Change in IL-6 level during the 28-day treatment period

  4. Mortality rate reduction [ Time Frame: throughout the study, about 3 months ]
    To determine whether EPA-FFA gastro-resistant capsules decreases mortality rate during the study.

  5. Reduction in ICU stays [ Time Frame: throughout the study, about 3 months ]
    To determine whether EPA-FFA gastro-resistant capsules decreases ICU days during the study.

  6. Reducing hospitalisation days [ Time Frame: throughout the study, about 3 months ]
    To determine whether EPA-FFA gastro-resistant capsules decreases hospitalisation days during the study

  7. reduction in need for mechanical ventilation [ Time Frame: throughout the study, about 3 months ]
    To determine whether EPA-FFA gastro-resistant capsules decreases the need for invasive mechanical ventilation during the study

  8. Fever reduction [ Time Frame: 28 days ]
    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


Other Outcome Measures:
  1. Safety - Vitals, AEs and Clinical lab parameters [ Time Frame: throughout the study, about 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335032


Contacts
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Contact: Justin Slagel 01923681001 jslagel@slapharma.com

Sponsors and Collaborators
S.L.A. Pharma AG
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Responsible Party: S.L.A. Pharma AG
ClinicalTrials.gov Identifier: NCT04335032    
Other Study ID Numbers: EPA-COV-001
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No