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A Randomised Double-blind Placebo-controlled Trial to Determine the Safety and Efficacy of Inhaled SNG001 (IFN-β1a for Nebulisation) for the Treatment of Patients With Confirmed SARS-CoV-2 Infection

Trial Profile

A Randomised Double-blind Placebo-controlled Trial to Determine the Safety and Efficacy of Inhaled SNG001 (IFN-β1a for Nebulisation) for the Treatment of Patients With Confirmed SARS-CoV-2 Infection

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 28 May 2020

At a glance

  • Drugs Interferon beta-1a
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Sponsors Synairgen
  • Most Recent Events

    • 28 May 2020 According to a Synairgen media release, recruitment of 100 hospitalised patients in this clinical trial of SNG001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients has now been completed.The 220 patient trial comprises 100 patients initiated in hospital and 120 patients initiated in the home setting.
    • 26 May 2020 According to a Synairgen media release, the Southampton Clinical Trials Unit from the University of Southampton have joined forces with Synairgen to conduct the clinical trial, with additional support provided by the primary care delivery team at the NIHR Clinical Research Network Wessex (CRN Wessex).
    • 26 May 2020 According to a Synairgen media release, the expanded trial includes patients who have had symptoms for less than 72 hours and are aged 50 or over with a high-risk comorbidity (such as cardiovascular disease, diabetes or a chronic lung condition), or aged 65 and over.Eligible patients are assessed via video call, and subsequently sent a swab by courier for self-swabbing.

Trial Overview

Purpose

This phase II trial is designed to assess the safety and efficacy of inhaled SNG001 (IFN-β1a for Nebulisation) for the treatment of patients with confirmed SARS-CoV-2 infection.
The study aims to test whether SNG001 is well tolerated, and can prevent or accelerate recovery of lower respiratory tract illness in patients with SARS-CoV-2 infection.

Primary Endpoints

Ordinal Scale for Clinical Improvement

description: Change in condition measured using the Ordinal Scale for Clinical Improvement during the dosing period - minimum of 0 (patient is well) to a maximum of 8 (death)
time_frame: Day 1 to day 28

Other Endpoints

Progression to pneumonia

description: Progression to pneumonia as diagnosed by chest x-ray, if no pneumonia is present at time of enrolment
time_frame: Day 2 to day 28

Progression to pneumonia

description: Evolution of pneumonia, as diagnosed by chest x-ray, if pneumonia is present at time of enrolment
time_frame: Day 1 to day 28

Time to clinical improvement

description: Time to clinical improvement
time_frame: Time to hospital discharge OR Time to NEWS2 of ≤ 2 maintained for 24 hours

National Early Warning Score 2 (NEWS2) assessment of acute-illness severity

description: NEWS2 assessment of acute-illness severity on a scale of 0 ( being well) up to 24 (requiring emergency response)
time_frame: Day 1 to day 28

Changes in daily breathlessness, cough and sputum scale (BCSS)

description: Changes in daily breathlessness, cough and sputum scale (BCSS) on a scale of 0 (no symptoms) up to 4 (severe symptoms)
time_frame: Day 1 to day 28

Safety and tolerability - blood pressure II. Viral load

description: Looking at blood pressure measured in mmHg
time_frame: Day 1 to day 28

Safety and tolerability - heart rate II. Viral load

description: Looking at heart rate measured in beats per minute
time_frame: Day 1 to day 28

Safety and tolerability - temperature II. Viral load

description: Looking at temperature measured in degrees Celsius
time_frame: Day 1 to day 28

Safety and tolerability - respiratory rate II. Viral load

description: Looking at respiratory rate measure in breaths per minute
time_frame: Day 1 to day 28

Safety and tolerability - oxygen saturation II. Viral load

description: Looking at oxygen levels measured in a %
time_frame: Day 1 to day 28

Safety and tolerability - adverse events II. Viral load

description: Looking at adverse events (numbers and terms)
time_frame: Day 1 to day 28

Safety and tolerability - concomitant medications II. Viral load

description: Looking at concomitant medications given during treatment
time_frame: Day 1 to day 28 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 400

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

Patient Inclusion Criteria

1. Positive virus test for SARS-CoV-2 using RT-PCR or positive point-of-care viral infection test in the presence of strong clinical suspicion of SARS-CoV-2 infection 2. Male or female, ≥18 years of age at the time of consent 3. Patients admitted to hospital due to the severity of their confirmed or suspected COVID-19 disease OR non-hospitalised patients from high-risk co-morbidity groups such as the >65-years of age, or those with hypertension, cardiovascular disease, diabetes, a chronic lung condition, cancer, or frontline healthcare workers. (The Sponsor will inform sites as to whether non-hospitalised patients are to be entered into the trial). 4. Provide informed consent. 5. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception.

Patient Exclusion Criteria

1. > 24 hours after confirmation of SARS-CoV-2 infection by RT-PCR test 2. Any condition, including findings in the patients' 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. 3. Current or previous participation in another clinical trial where the patient has received a dose of an 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. 4. Ventilated or in intensive care 5. Inability to use a nebuliser with a mouthpiece. 6. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation. 7. Patients that are taking an antiviral treatment (e.g. zanamivir or oseltamivir) prior to randomisation and/or on the day of randomisation 8. Female who are breast-feeding, lactating, pregnant or intending to become pregnant.

Trial Details

Identifiers

Identifier Owner
NCT04385095 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001023-14 European Clinical Trials Database
SG016 -

Organisations

  • Sponsors Synairgen
  • Affiliations Synairgen

Trial Dates

  • Initiation Dates

    Actual : 16 Mar 2020

  • Primary Completion Dates

    Planned : 31 Aug 2020

  • End Dates

    Planned : 31 May 2021

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location England; Northern Ireland; United Kingdom
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Interferon beta-1a Inhalation Solution

SNG001

inhalation using the I-neb device.
Drug: Interferon beta 1a (Interferon Beta-1A via inhalation) Other Name: SNG001

Placebo

inhalation using the I-neb device.
Drug: Placebo (Placebo via inhalation)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Davinder Dosanjh, DPhil, MRCP, FHEA Queen Elizabeth Hospital, United-Kingdom
Dinesh Saralaya, MBBS MD MRCP FRCP Bradford Royal Infirmary United-Kingdom
Jaclyn Smith, MB ChB MRCP PhD FRCP Wythenshawe Hospital United-Kingdom
Jody Brookes
02380512800
jody.brookes@synairgen.com
show details
Synairgen Research Limited United-Kingdom
Lorcan McGarvey, MD FRCP Belfast City Hospital United-Kingdom
Michael Crooks, MBBS Hull and East Yorkshire NHS Trust, Castle Hill Hospital, United-Kingdom
Najib Rahman, MB BCh MA John Radcliffe Hospital United-Kingdom
Salman Siddiqui, Fellow of the Royal College of Glenfield Hospital, United-Kingdom
Sophie Hemmings
02380512800
sophie.hemmings@synairgen.com
show details
Synairgen Research Limited United-Kingdom
Tim Harrison, MBBS FRCP MD City Campus of Nottingham University United-Kingdom
Tom Wilkinson
t.wilkinson@soton.ac.uk
show details
University Hospital Southampton Nhs Foundation Trust United-Kingdom

Centres

Centre Name Location Trial Centre Country
Belfast City Hospital Belfast United-Kingdom
Bradford Royal Infirmary Bradford United-Kingdom
City Campus of Nottingham University Nottingham United-Kingdom
Glenfield Hospital, Leicester United-Kingdom
Hull and East Yorkshire NHS Trust, Castle Hill Hospital, Hull United-Kingdom
John Radcliffe Hospital Oxford United-Kingdom
Queen Elizabeth Hospital, Birmingham United-Kingdom
Synairgen Research Limited
-
United-Kingdom
University Hospital Southampton Nhs Foundation Trust Southampton United-Kingdom
Wythenshawe Hospital Manchester United-Kingdom

Trial History

Event Date Event Type Comment
28 May 2020 Other trial event According to a Synairgen media release, recruitment of 100 hospitalised patients in this clinical trial of SNG001 (inhaled formulation of interferon-beta-1a) in COVID-19 patients has now been completed.The 220 patient trial comprises 100 patients initiated in hospital and 120 patients initiated in the home setting. Updated 01 Jun 2020
26 May 2020 Other trial event According to a Synairgen media release, the Southampton Clinical Trials Unit from the University of Southampton have joined forces with Synairgen to conduct the clinical trial, with additional support provided by the primary care delivery team at the NIHR Clinical Research Network Wessex (CRN Wessex). Updated 01 Jun 2020
26 May 2020 Other trial event According to a Synairgen media release, the expanded trial includes patients who have had symptoms for less than 72 hours and are aged 50 or over with a high-risk comorbidity (such as cardiovascular disease, diabetes or a chronic lung condition), or aged 65 and over.Eligible patients are assessed via video call, and subsequently sent a swab by courier for self-swabbing. Updated 01 Jun 2020
26 May 2020 Other trial event According to a Synairgen media release, data from the hospital initiated (late) patient and home initiated (early) patient populations will be analysed separately as soon as possible, and then together as one population at the end. Updated 01 Jun 2020
26 May 2020 Other trial event According to a Synairgen media release, Synairgen initiates dosing of SNG001 in home setting to treat patients earlier in the illness.Recruitment for the home setting of the trial will depend on the prevalence of the virus in the community and the degree to which the targeted at risk patients become infected. The novel, virtual trial design, means it is readily scalable if necessary. Updated 01 Jun 2020
26 May 2020 Other trial event According to an Synairgen media release, the company is extending this SG016 study to patients in the home environment with confirmed COVID-19, to initiate dosing with SNG001 (or placebo) earlier in the course of the illness and before severe lower respiratory tract symptoms develop. Dosing in the home environment is expected to commence in May 2020. Updated 27 May 2020
26 May 2020 Other trial event According to an Synairgen media release, 98 patients out of the target of 100 patients are now dosed in the hospital setting in this study. Results from this part of the study are expected in July 2020. Updated 27 May 2020
14 May 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04385095). Updated 14 May 2020
30 Apr 2020 Other trial event According to an Synairgen media release, the company has received approvals to extend this study to dose patients with SNG001 in the home environment earlier in the infection cycle, and before severe lower respiratory tract symptoms have developed. The company will disclose the detailed design, implementation and timing of this study. Till now 75 patients are been dosed in this study. Data from these patients are still expected in June 2020. Updated 06 May 2020
14 Apr 2020 Other trial event According to an Synairgen media release, The trial has now been labelled as an Urgent Public Health study by the National Institute for Health Research (NIHR). Further updates will be made in due course. Updated 15 Apr 2020
31 Mar 2020 Other trial event According to an Synairgen media release, the initial pilot phase of the study will involve 100 COVID-19 patients, will take place across a number of NHS trusts and has been adopted by the NIHR Respiratory Translational Research Collaboration which is comprised of leading centres in respiratory medicine in the UK. A successful outcome from the pilot phase will inform onwards progression of SNG001 in COVID19 patients. Updated 02 Apr 2020
31 Mar 2020 Other trial event According to an Synairgen media release, the company has now commenced dosing patients in this trial. The first patient has been dosed at the initial trial site (University Hospital Southampton NHS Foundation Trust). The company has initiated a further six trial sites which are expected to start dosing in the coming days. Updated 02 Apr 2020
30 Mar 2020 Other trial event Last checked against European Clinical Trials Database record. Updated 30 Mar 2020
24 Mar 2020 Other trial event New source identified and integrated,European Clinical Trials Database:EudraCT2020-001023-14. Updated 24 Mar 2020
19 Mar 2020 New trial record New trial record Updated 19 Mar 2020
18 Mar 2020 Other trial event According to a Synairgen media release, the company has received expedited approvals from the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) to conduct this trial. The company expects to initiate the trial soon. Updated 19 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Synairgen. Approval received to extend SG016 clinical study of SNG001 in COVID-19 to initiate patients in the home environment. Media-Rel 2020;.

    Media Release
  3. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  4. Synairgen. Synairgen plc: Preliminary results for the year ended 31 December 2019. Media-Rel 2020;.

    Media Release
  5. Synairgen. Result of General Meeting:Synairgen plc. Media-Rel 2020;.

    Media Release
  6. Synairgen. Synairgen confirms commencement of dosing in trial of SNG001 in COVID-19. Media-Rel 2020;.

    Media Release
  7. Synairgen. Synairgen plc - Update on expanded SG016 trial for patients with COVID-19:Synairgen initiates dosing of SNG001 in home setting to treat patients earlier in the illness. Media-Rel 2020;.

    Media Release
  8. Synairgen. Synairgen Completes Recruitment of Hospitalised Patients in COVID-19 Trial. Media-Rel 2020;.

    Media Release
  9. Synairgen. Synairgen to start trial of SNG001 in COVID-19 imminently. Media-Rel 2020;.

    Media Release
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