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

NCT04335032 | Unknown Phase 3

• 1 other identifier: EPA-COV-001
• Study Type: interventional
• Target: 284
• Locations: 2 countries
• Sites: 5

Brief Summary

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

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Evaluation of EPA-FFA efficacy compared to placebo

  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.

  28 days

Secondary Outcomes (5)

• Time to and amount of clinical improvement

  28 days

• Change in recovery and survival rate

  28 days

• Reduction of CRP and IL-6

  28 days

• Increase in IFN-γ

  28 days

• Reduction in proinflammatory chemokines and cytokines.

  28 days

Other Outcomes (1)

• Safety - Vitals, AEs and Clinical lab parameters

  throughout the study, about 3 months

Study Arms (2)

Eicosapentaenoic acid gastro-resistant capsules

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo capsules that cannot be visually differentiated from the active treatment

Drug: Placebo

Interventions

Eicosapentaenoic acid gastro-resistant capsules DRUG

same as in arm/group description

Also known as: Alfa

Eicosapentaenoic acid gastro-resistant capsules

Placebo DRUG

same as in arm/group description

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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; 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).
• Positive local approved test to confirm diagnosis of SARS-CoV-2 within 7 days prior to baseline.
• 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%.
• 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.

You may not qualify if:

• 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 \> 20 L/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 them for the duration of the study.
• Taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study.
• Used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to Screening.
• Participating in other clinical studies at the same time.

Sponsors & Collaborators

• S.L.A. Pharma AG: lead

Study Sites (5)

Hospital Universitario Vall d'Hebron

Barcelona, 119 129, Spain

RECRUITING

Hull

Cottingham, HU16 5JQ, United Kingdom

RECRUITING

UHCW

Coventry, CV2 2DX, United Kingdom

RECRUITING

NPH

Harrow, HA1 3UJ, United Kingdom

RECRUITING

Rotherham NHS Foundation Trust

Rotherham, S60 2UD, United Kingdom

RECRUITING

Central Study Contacts

Justin Slagel

CONTACT

01923681001; jslagel@slapharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: January 8, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 1, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); GB (4)