Clinical Trials Register

Summary
EudraCT Number:	2020-001396-33
Sponsor's Protocol Code Number:	EPA-COV-001
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	GB - no longer in EU/EEA
Date on which this record was first entered in the EudraCT database:	2020-04-09
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2020-001396-33

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled study of eicosapentaenoic acid (EPA-FFA) gastro-resistant capsules to treat hospitalised subjects with confirmed SARS-CoV-2

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

EPA-FFA to treat hospitalised patients with SARS-CoV-2

A.4.1

Sponsor's protocol code number

EPA-COV-001

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04335032

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	SLA Pharma (UK) Ltd
B.1.3.4	Country	United Kingdom
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	KD Swiss GmbH
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SLA Pharma (UK) Ltd
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Building 5, Leavesden Park, Hercules Way
B.5.3.2	Town/ city	Watford
B.5.3.3	Post code	WD25 7GS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+441923681001
B.5.5	Fax number	+441923616950
B.5.6	E-mail	jslagel@slapharma.com
B.Sponsor: 2
B.1.1	Name of Sponsor	KD Swiss GmbH
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	KD Swiss GmbH
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SLA Pharma (UK) Ltd
B.5.2	Functional name of contact point	Justin Slagel
B.5.3	Address:
B.5.3.1	Street Address	Building 5, Leavesden Park, Hercules Way
B.5.3.2	Town/ city	Watford
B.5.3.3	Post code	WD25 7GS
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	00441923681001
B.5.5	Fax number	00441923616950
B.5.6	E-mail	jslagel@slapharma.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	EPA-FFA gastro-resistant capsules
D.3.2	Product code	EPA-FFA
D.3.4	Pharmaceutical form	Gastro-resistant capsule, soft
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Icosapent
D.3.9.1	CAS number	25378-27-2
D.3.9.3	Other descriptive name	Eicosapentaenoic acid
D.3.9.4	EV Substance Code	SUB13664MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Gastro-resistant capsule, soft
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

SARS-CoV-2

E.1.1.1

Medical condition in easily understood language

SARS-CoV-2

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.0
E.1.2	Level	LLT
E.1.2	Classification code	10084272
E.1.2	Term	SARS-CoV-2 infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to evaluate the efficacy of EPA-FFA gastro-resistant capsules compared to placebo, with respect to disease progression in subjects with a confirmed diagnosis of SARS-CoV-2.

E.2.2

Secondary objectives of the trial

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.
- increases the number of subjects alive and discharged home without supplemental oxygen therapy.
- decreases IL-6 during the study.
- decreases CRP during the study.
- increases IFN-γ during the study.
- decreases other pro-inflammatory chemokines and cytokines.

Safety objectives:
- to evaluate the safety of EPA-FFA gastro-resistant capsules in the treatment of SARS-CoV-2.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, aged 18 years and above.
2. Provided informed consent prior to any study specific procedure being conducted.
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 (eg 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.

E.4

Principal exclusion criteria

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. Subjects who are 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. Subjects who are 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 to 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.

E.5 End points

E.5.1

Primary end point(s)

Proportion of subjects alive and free of respiratory failure at 28 days. Respiratory failure will be defined as at least one of the following:
1. Endotracheal intubation and mechanical ventilation.
2. Oxygen delivered by high-flow nasal cannula.
3. Non-invasive positive pressure ventilation or continuous positive airway pressure (CPAP).
4. Extracorporeal membrane oxygenation (ECMO).

E.5.1.1

Timepoint(s) of evaluation of this end point

4 weeks

E.5.2

Secondary end point(s)

▪ Time to 2-point improvement in the WHO 9-point ordinal scale during the 28-day treatment period.
▪ Responders: Proportion of subjects achieving a 2-point improvement on the WHO 9-point scale, or a live discharge from the hospital, or who is considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale) during the 28-day treatment period.
▪ Change in the WHO 9-point ordinal scale.
▪ Proportion of subjects alive and discharged home without oxygen at 28 days.
▪ Change in PaO2/FiO2 and/or SaO2/FiO2.
▪ Change in CRP level.
▪ Change in pro-inflammatory chemokines and cytokines (IL-6, IFN-γ).
▪ Duration of assisted ventilation.
▪ Duration of hospitalisation.
▪ Overall mortality.
▪ Readmission for COVID-19 related symptoms/disease

Safety endpoints:
▪ Number and proportion of subjects with AEs and SAEs.
▪ Assessment of clinical laboratory parameters.
▪ Assessment of vital signs.

E.5.2.1

Timepoint(s) of evaluation of this end point

4 weeks

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

France

Ireland

Israel

South Africa

Spain

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

234

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-09.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

284

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

If the study drug has been shown to be beneficial, and it is permitted by the competent authority for that country, it may be available to subjects after the study has finished. This will be in a managed access program from a subject’s study doctor, which will be separate to this study.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2020-04-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-11-13

P. End of Trial
P.	End of Trial Status	GB - no longer in EU/EEA

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials