Clinical Trials Register

Summary
EudraCT Number:	2020-004743-83
Sponsor's Protocol Code Number:	SG018
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:	2020-10-26
Trial results	View 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

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2020-004743-83

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19

A.3.1

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

A trial of an inhaled antiviral drug to treat or prevent severe respiratory difficulties in patients hospitalised with moderate COVID-19

A.3.2

Name or abbreviated title of the trial where available

Phase III trial of inhaled anti-viral (SNG001) for SARS-CoV-2

A.4.1

Sponsor's protocol code number

SG018

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	Synairgen Research Limited
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	Synairgen Research Ltd
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Synairgen Research Ltd
B.5.2	Functional name of contact point	Sophie Hemmings
B.5.3	Address:
B.5.3.1	Street Address	Mail Point 810, Level F, Southampton General Hospital
B.5.3.2	Town/ city	Tremona Road, Southampton
B.5.3.3	Post code	SO16 6YD
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	02380512800
B.5.5	Fax number	02380512800
B.5.6	E-mail	Sophie.Hemmings@synairgen.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	Interferon beta-1a (IFN-β1a)
D.3.2	Product code	SNG001
D.3.4	Pharmaceutical form	Inhalation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Interferon beta-1a
D.3.9.2	Current sponsor code	SNG001
D.3.9.4	EV Substance Code	AS1
D.3.10	Strength
D.3.10.1	Concentration unit	million IU million international units
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	12
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	No
D.3.11.9	Recombinant medicinal product	Yes
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	Nebuliser solution
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

COVID-19

E.1.1.1

Medical condition in easily understood language

Lung disease caused by the new coronavirus

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	PT
E.1.2	Classification code	10051905
E.1.2	Term	Coronavirus infection
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo.

E.2.2

Secondary objectives of the trial

To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19, using a range of endpoints.

To assess the general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, ≥18 years of age at the time of consent.
2. Admitted to hospital due to the severity of their COVID-19.
3. Positive virus test for SARS-CoV-2 using a validated molecular assay (e.g. RT-PCR). Patients who had positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test was performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection.
4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4).
5. Provide informed consent.
6. Female patients must be ≥1 year post-menopausal, surgically sterile, or using a highly effective method of contraception. Acceptable highly effective methods of contraception include;
• bilateral tubal occlusion
• intrauterine device (provided coils are copper-banded)
• levonorgestrel intrauterine system (e.g., Mirena™)
• medroxyprogesterone injections (e.g., Depo-Provera™)
• etonogestrel implants (e.g., Implanon™, Norplan™)
• normal and low dose combined oral pills
• norelgestromin/ ethinylestradiol transdermal system
• intravaginal device (e.g., ethinylestradiol and etonogestrel), desogestrel (e.g., Cerazette™)
• total sexual abstinence (defined as refraining from heterosexual intercourse)
• vasectomised sexual partner.
Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled IFN-β1a/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-β1a/matching placebo to prevent pregnancy.
7. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal
if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply:
• Women <50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the
postmenopausal range.
• Women ≥50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.

If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.

E.4

Principal exclusion criteria

1. Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay e.g. RT-PCR test.
2. Mechanical ventilation (continuous or intermittent CPAP or intubation) or admission to intensive care.
3. Previous SARS-CoV-2 infection confirmed by a validated molecular assay e.g. RT-PCR test.
4. Any condition, including findings in the patient’s medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study
or that could interfere with the study objectives, conduct or evaluation.
5. Participation in previous clinical trials of SNG001.
6. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry
into this study or containing biologicals within 3 months prior to entry into this study.
7. Inability to use a nebuliser with a mouthpiece.
8. Inability to comply with the requirements for storage conditions of study medication in the home setting.
9. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
10. Females who are breast-feeding, lactating, pregnant or intending to become pregnant

E.5 End points

E.5.1

Primary end point(s)

Time to recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments.

E.5.1.1

Timepoint(s) of evaluation of this end point

OSCI assessments will be conducted daily between day 1 and day 35. Time to recovery will be assessed over the first 28 days of the study period. The OSCI assessments after day 28 will be used to assess relapse only.

E.5.2

Secondary end point(s)

Key Secondary Endpoints:
a. Progression to severe disease or death, defined by the OSCI score of 5 or above within 28 days of first dose.
b. Time to hospital discharge, defined by the OSCI score of 2 or below, with no rebound at subsequent assessments.

Secondary Endpoints:
a. Progression to intubation or death, defined by the OSCI score of 6 or above within 28 days of first dose.
b. Death within 28 days of first dose.
c. Recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments, at Days 7, 14, 21 and 28.
d. Hospital discharge at Days 7, 14, 21 and 28.
e. Improvement across the entire OSCI at Days 7, 14, 21 and 28.
f. Changes in breathlessness, cough and sputum scale (BCSS) score during the study period, including disaggregated breathlessness and cough scores.
g. Changes in National Early Warning Score 2 (NEWS2) during the hospitalisation period.
h. Quality of life measured using EQ-5D-5L.
i. Long-COVID-19 symptoms.
j. Safety and tolerability – vital signs, AEs and concomitant medications.

E.5.2.1

Timepoint(s) of evaluation of this end point

Key secondary endpoints
Progression to severe disease or death will be assessed using all post-baseline OSCI assessments up to day 28.
Time to hospital discharge will be assessed over the first 28 days of the study period. The OSCI assessments after day 28 will be used to assess relapse only.
For Secondary endpoints the timepoints for evaluation are stated in the endpoint wording as per questions E5-2.

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

Yes

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

150

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

Argentina

Belgium

Brazil

Canada

Chile

Colombia

France

Germany

India

Israel

Italy

Mexico

Moldova, Republic of

Netherlands

Peru

Poland

Portugal

Romania

Russian Federation

Serbia

South Africa

Spain

Turkey

Ukraine

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