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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: 31 Aug 2020

At a glance

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

    • 25 Aug 2020 Planned number of patients changed from 400 to 820.
    • 25 Aug 2020 Planned primary completion date changed from 31 Aug 2020 to 1 Feb 2021.
    • 21 Jul 2020 According to a Synairgen media release, the company will be working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible.

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 Days 15 and 28

Other Endpoints

Progression to pneumonia (hospital setting only)

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 (hospital setting only)

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 (hospital setting only)

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 (hospital setting only)

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

Time to clinical improvement (home setting only)

description: Temperature ≤37.8 °C AND COVID-19 symptoms (breathing, cough, sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell and taste, rhinorrhoea and anorexia) all rated as absent or mild
time_frame: Day 1 to Day 28

Time to improvement of COVID-19 symptoms (home setting only).

description: Time to improvement of COVID-19 symptoms (fever, breathing, cough, sputum, muscle aches, headache, fatigue, sore throat, loss or change to sense of smell and/or taste, rhinorrhoea and anorexia)
time_frame: Day 1 to Day 28

Time to self-reported recovery (home setting only)

description: Time to self-reported recover
time_frame: Day 2 to Day 16

Self-reported daily rating of overall feeling of wellness (home setting only).

description: Self-reported daily rating of overall feeling of wellness
time_frame: Day 1 to Day 28

Quality of life measured using EQ-5D-5L (home setting only).

description: Quality of life measured using EQ-5D-5L
time_frame: Day 1 to Day 28

Virus clearance/load (if samples are available)

description: Time to virus clearance and viral load
time_frame: Day 1 to Day 28

Blood and sputum biomarkers (if samples are available).

description: Blood and sputum biomarkers
time_frame: Day 1 to Day 28

Contact with health services (home setting only

description: Contact with health services
time_frame: Day 1 to Day 28

Consumption of antibiotics (home setting only

description: Consumption of antibiotics
time_frame: Day 1 to Day 28 [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 820

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

Patient Inclusion Criteria

1. A. Hospital setting: 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. B. Home setting: positive virus test for SARS-CoV-2 using a molecular assay e.g. RT-PCR in the presence of strong clinical suspicion of SARS-CoV-2 infection. 2. Male or female, ≥18 years of age (hospital setting) or ≥50 years of age (home setting) at the time of consent. 3. A. Hospital setting: patients admitted to hospital due to the severity of their COVID 19 disease OR B. Home setting: non-hospitalised patients from high-risk groups, defined as ≥65-years of age, or ≥50 years of age and with any of the following risk factors: - Arterial hypertension - Cardiovascular disease - Diabetes mellitus - Chronic lung disease - Chronic kidney disease (eGFR <60 mL/min/1.73m2) - Chronic liver disease - Immunodeficiency due to a serious illness or medication - Cerebrovascular disease - Malignancy (except basal cell carcinoma) diagnosed in the last 5 years - Body Mass Index ≥30 who present with clinical symptoms consistent with COVID-19: - High temperature and/or - New, continuous cough. - Loss or change to sense of smell and/or taste 4. Provide informed consent. 5. A. Hospital setting: hospitalised female patients must be ≥1 year post-menopausal, surgically sterile, or using an acceptable method of contraception. B. Home setting: non-hospitalised female patients must be ≥1 year post-menopausal or surgically sterile.

Patient Exclusion Criteria

1. > 24 hours after confirmation of SARS-CoV-2 infection by a molecular assay e.g. RT-PCR test (hospital and home settings) or >24 hours after a positive point-of-care viral infection test (hospital setting only). This criterion does not apply to patients in the hospital setting who had their positive RT-PCR test for SARS-CoV-2 performed prior to hospitalisation. 2. >96 hours from onset of COVID-19 symptoms (cough and/or fever and/or loss or change to sense of smell and/or taste; home setting only). 3. 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. 4. 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. 5. Ventilated or in intensive care. 6. Inability to use a nebuliser with a mouthpiece. 7. History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation. 8. Females 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
ISRCTN14241621 ISRCTN: Current Controlled Trials
SG016 -
IRAS 281317 -

Organisations

  • Sponsors Synairgen
  • Affiliations Synairgen

Trial Dates

  • Initiation Dates

    Actual : 16 Mar 2020

  • Primary Completion Dates

    Planned : 01 Feb 2021

  • 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: SNG001 (SNG001 via inhalation)

Placebo

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

Results

Therapeutic efficacy

COVID-2019 infections
Interim results from the phase II trial of SNG 001 in hospitalised COVID-19 patients, demonstrated that patients who received SNG 001 had a 79% lower risk of developing severe disease compared to placebo (OR 0.21 [95% CI: 0.04-0.97]; p=0.046) and were more than twice as likely to recover from COVID-19 as those on placebo (HR 2.19 [95% CI: 1.03-4.69]; p=0.043). Over the treatment period, the measure of breathlessness was markedly reduced in patients who received SNG 001 compared to those receiving placebo (p=0.007). 6% died after being randomised to placebo. There were no deaths among subjects treated with SNG 001. In the patients requiring treatment with supplemental oxygen at time of admission, SNG 001 treatment increased the likelihood of hospital discharge during the study (HR 1.72 [95% CI: 0.91-3.25]; p=0.096). Median time to discharge was six days for patients treated with SNG 001 and nine days for those receiving placebo. The efficacy analyses also indicated no evidence of an association between the SNG 001 positive treatment effects and prior duration of COVID-19 symptoms. Patient groups were evenly matched in terms of average age, comorbidities and average duration of COVID-19 symptoms prior to enrolment (9.8 days for placebo and 9.6 days for SNG 001). Results demonstrated that the inhalation of interferon beta reduced the number of patients needing intensive care. The treatment was delivered through a nebulizer and inhaled directly into the lungs of patients with coronavirus. The study highlighted how patients were two to three times more likely to recover to the point where everyday activities were not compromised by their illness. The average time patients spent in hospital was reduced by a third from an average of nine days to six days [2] .

Publications

  1. Synairgen. Synairgen announces positive results from trial of SNG001 in hospitalised COVID-19 patients. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Synairgen 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
-
Belfast City Hospital, Bradford Royal Infirmary, Castle Hill Hospital, City Hospital, Glenfield Hospital, John Radcliffe Hospital, Manchester University NHS Foundation Trust, Oaks Healthcare, Park & St Francis Surgery, Queen Elizabeth Hospital, Southampton General Hospital, The Adam Practice United-Kingdom
Jody Brookes
Synairgen Research Ltd
Level F (810)
South Block
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)2380 512900
covidtrialathome@soton.ac.uk
02380512800
jody.brookes@synairgen.com
https://www.synairgen.com/
show details
Synairgen Research Limited United-Kingdom
Sophie Hemmings
02380512800
sophie.hemmings@synairgen.com
https://www.synairgen.com/
show details
Synairgen Research Limited United-Kingdom

Centres

Centre Name Location Trial Centre Country
Belfast City Hospital Belfast United-Kingdom
Bradford Royal Infirmary Bradford United-Kingdom
Castle Hill Hospital Hull United-Kingdom
City Hospital Nottingham United-Kingdom
Glenfield Hospital Leicester United-Kingdom
John Radcliffe Hospital Oxford United-Kingdom
Manchester University NHS Foundation Trust Manchester United-Kingdom
Oaks Healthcare Waterlooville United-Kingdom
Park & St Francis Surgery Eastleigh United-Kingdom
Queen Elizabeth Hospital Birmingham United-Kingdom
Southampton General Hospital Southampton United-Kingdom
Synairgen Research Limited
-
United-Kingdom
The Adam Practice Poole United-Kingdom

Trial History

Event Date Event Type Comment
31 Aug 2020 Other trial event Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 31 Aug 2020
25 Aug 2020 Other trial event Planned number of patients changed from 400 to 820. Updated 31 Aug 2020
25 Aug 2020 Other trial event Planned primary completion date changed from 31 Aug 2020 to 1 Feb 2021. Updated 31 Aug 2020
27 Jul 2020 Other trial event New source identified and integrated: (ISRCTN: Current Controlled Trials ISRCTN14241621). Updated 27 Jul 2020
21 Jul 2020 Other trial event According to a Synairgen media release, the company will be working with the regulators and other key groups to progress this potential COVID-19 treatment as rapidly as possible. Updated 23 Jul 2020
20 Jul 2020 Other trial event Recruitment completion is expected on 30 Apr 2021, according to ISRCTN: Current Controlled Trials record. Updated 27 Jul 2020
20 Jul 2020 Other trial event According to a Synairgen media release, 101 patients recruited from 9 specialist hospital sites in the UK during the period 30 March to 27 May 2020 and patient groups were evenly matched in terms of average age (56.5 years for placebo and 57.8 years for SNG001), comorbidities and average duration of COVID-19 symptoms prior to enrolment (9.8 days for placebo and 9.6 days for SNG001). Updated 21 Jul 2020
20 Jul 2020 Other trial event According to a Synairgen media release, further analysis will be conducted over the coming weeks and reported in due course. Updated 21 Jul 2020
20 Jul 2020 Other trial event According to a Synairgen media release, A briefing for journalists will be held via webinar. Updated 21 Jul 2020
20 Jul 2020 Results Positive results from a hospitalised COVID-19 patients presented in a Synairgen media release. Updated 21 Jul 2020
18 Jun 2020 Other trial event According to a Synairgen media release, the company is on track to report the results of the 100 patients who have been successfully treated in the hospital setting in July. Updated 24 Jun 2020
18 Jun 2020 Other trial event According to a Synairgen media release, visits to the trial website for SNG001 have shown that the majority of eligible patients who have completed the online assessment have lived too far from Synairgen's virus testing laboratory in Southampton for entry into the trial. Synairgen has therefore amended the trial protocol. Updated 24 Jun 2020
18 Jun 2020 Other trial event According to a Synairgen media release, All trial supplies, including a pulse oximeter, thermometer, nebuliser and the trial drug, will be delivered directly to the patient (home setting), minimising the chance of spreading the virus. Updated 24 Jun 2020
18 Jun 2020 Protocol amendment According to a Synairgen media release, the trial has been expanded beyond the Southampton area to include patients across the majority of the UK. Patients in almost any part of the UK who have tested positive for coronavirus, and meet the additional eligibility criteria, can now participate in the home setting arm of the trial.Daily video calls with a doctor or nurse will be conducted to supervise dosing with the study medication and for the assessment of trial endpoints. Updated 24 Jun 2020
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. Synairgen announces positive results from trial of SNG001 in hospitalised COVID-19 patients. Media-Rel 2020;.

    Media Release
  3. 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
  4. Synairgen. National expansion of Synairgen's home-based COVID-19 trial of inhaled SNG001. Media-Rel 2020;.

    Media Release
  5. ISRCTN: Current Controlled Trials. Trial-Reg 2016;.

    Available from: URL: http://www.controlled-trials.com
  6. Synairgen. Clarification regarding trial of SNG001 in hospitalised COVID-19 patients. Media-Rel 2020;.

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

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

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

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

    Media Release
  11. 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
  12. Synairgen. Synairgen Completes Recruitment of Hospitalised Patients in COVID-19 Trial. Media-Rel 2020;.

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

    Media Release
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