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
Latest Information Update: 05 Jan 2023
At a glance
- Drugs Interferon beta-1a (Primary)
- Indications COVID 2019 infections
- Focus Therapeutic Use
- Sponsors Synairgen
- 03 Jan 2023 Status changed from active, no longer recruiting to completed.
- 30 Apr 2021 According to a Synairgen media release, the company plans to submit the findings for peer review at an upcoming medical conference or publication.
- 30 Apr 2021 Results from the home cohort and data from the combined analysis of the hospital and home cohorts, presented in a Synairgen media release.
Most Recent Events
Trial Overview
Outcome
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.
This trial targets patients with a positive SARS-CoV-2 test result who are aged over 65 and those over the age of 50 with 'high risk' medical conditions. It is a trial designed to make it easy and safe for trial participants and researchers to conduct the research; all supplies for the trial are delivered directly to the patient's door by courier, and all trial visits and assessments are conducted virtually by video call.
Synairgen's two-part, placebo-controlled trial evaluating SNG001 as a treatment for COVID-19 infection involved dosing of (i) 101 patients in the hospital setting (ii) 120 'at risk' patients in the home setting.
Primary Endpoints
−Change in clinical condition using the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period in the intention-to-treat population (ITT): pilot phase of inpatients [1]
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 (and Day 60 and 90 home setting only)
Safety and tolerability - blood pressure (hospital setting only)
description: Looking at blood pressure measured in mmHg time_frame: Day 1 to Day 15
Safety and tolerability - heart rate
description: Looking at heart rate measured in beats per minute time_frame: Day 1 to Day 15
Safety and tolerability - temperature
description: Looking at temperature measured in degrees Celsius time_frame: Day 1 to Day 15
Safety and tolerability - respiratory rate (hospital setting only)
description: Looking at respiratory rate measure in breaths per minute time_frame: Day 1 to Day 15
Safety and tolerability - oxygen saturation
description: Looking at oxygen levels measured in a % time_frame: Day 1 to Day 15
Safety and tolerability - adverse events
description: Looking at adverse events (numbers and terms) time_frame: Day 1 to Day 28
Safety and tolerability - concomitant medications
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 15
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 and Day 60 and 90
Time to self-reported recovery (home setting only)
description: Time to self-reported recover time_frame: Day 2 to Day 15 and Day 28, 60 and 90
Self-reported daily rating of overall feeling of wellness (home setting only).
description: Self-reported daily rating of overall feeling of wellness scale from 1 (the worst you can imagine) to 10 (the best you can imagine) time_frame: Day 1 to Day 28 and Day 60 and 90
Quality of life measured using EQ-5D-5L (home setting only).
description: Quality of life measured using EQ-5D-5L - 5 questions where minimum score is 1 (best outcome) to 5 (worst outcome), visual analogue scale is also included for this 100 is best health you can imagine to 0 worst health you can imagine time_frame: Day 1 to Day 28 and Day 60 and 90
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
General Anxiety Disorder 7 (home setting only)
description: Assessment of anxiety - score of 0 (best) to 3 (worst) time_frame: Day 60 and 90
Patient Health Questionnaire - 9
description: Assessment of mental health - score of 0 (best) to 3 (worst) time_frame: Day 60 and 90
FACIT Fatigue Scale
description: Assessment of Fatigue - score of 0 (best) to 4 (worst) time_frame: Day 60 and 90
Nottingham Extended Activities of Daily Living Scale
description: Assessment of activities of daily living - no score just tick the box that applies; 'Not at all', 'With help', 'On your own with difficulty' and 'On your own' time_frame: Day 60 and 90 [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | treatment | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04385095 | interferon, beta 1, fibroblast | Brief Summary |
Subjects
- Subject Type patients
-
Number
Planned: 820
Actual: 221
- Sex male & female
- Age Group ≥ 18 years; adult
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. ≥ 8 days 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
Actual : 17 Feb 2021
-
End Dates
Planned : 31 May 2021
Actual : 16 Nov 2021
Other Details
- Design double-blind; multicentre; parallel; prospective; randomised
- Phase of Trial Phase II
- Location England; United Kingdom; United Kingdom (Northern Ireland)
- Focus Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| Interferon beta-1aPrimary Drug | 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
In the SG016 phase II trial of interferon beta 1a in COVID-19 patients, in the home cohort in total, only two patients were admitted to hospital during the treatment period, both from the placebo group. However, reduction in the relative risk (RRR) of progression to severe disease or death within 35 days (25.7% reduction in the Intention-to-Treat population and 36.3% reduction in the Per Protocol population). Interferon beta 1a significantly reduced the risk of progression to severe disease and death compared to placebo by 70% in the Per Protocol population (Odds Ratio (95% Confidence Interval) 0.23 (0.06, 0.98); p=0.046). Consequently, the prevention of severe lower respiratory tract (LRT) illness could not be determined. The majority of patients exhibited only mild disease which compromised the possibility of showing treatment effects in the home cohort [3] . 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 [4] . Primary endpoint analyses showed that greater odds of improvement were observed. Strong trend towards reduced odds of progression to severe disease or death in the ITT population that became significant in the per-protocol population was observed. Odds of improvement across the OSCI at day 15/16 compared with baseline in ITT population was OR 2.32 [(95%CI: 1.07, 5.04), P value = 0.033] and in PP population OR 2.80 [(95%CI: 1.21, 6.52), p value = 0.017]. Also, time to recovery from first dose to no limitation of activity analysis showed HR 2.19 [(95%CI: 1.03, 4.69), p value = 0.043] in ITT population while HR 2.29 [(95%CI: 1.07, 4.91), p value = 0.033] in PP population. Odds of recovery analysis (time to first dose to no limitation of activities without subsequent relapse) showed OR 3.19 [(95%CI: 1.24, 8.24), p value=0.017] in ITT population and OR 3.18 [(95%CI: 1.21, 8.39), p value = 0.019] in PP population. Time to hospital discharge with no subsequent hospital re-admission analysis showed HR 1.37 [(95%CI: 0.85, 2.20), p value = 0.196] and HR 1.53 [(95%CI: 0.96, 2.42), p value = 0.072] in ITT and PP population respectively. Odds of hospital discharge analysis showed OR 1.63 [(95%CI: 0.61, 4.35), p value = 0.330] in ITT population and OR 2.14 [(95%CI: 0.64, 7.12), p value = 0.215] in PP population. Additionally, time to severe disease or death (time from first dose until first incidence of OSCI ≥ 5) in ITT population was HR 0.50 [(95%CI: 0.18, 1.38), p value = 0.179]. Odds of severe disease or death in ITT population was OR 0.28 [(95%CI: 0.07, 1.08), p value = 0.064] compared with OR 0.18 [(95%CI: 0.04, 0.93), p value = 0.041] in PP population. Time to incubation or death was HR 0.38 [(95%CI: 0.09, 1.65), p value = 0.198] in ITT population. Odds to incubation or death in ITT population was OR 0.42 [(95%CI: 0.09, 1.83), p value = 0.246] compared with OR 0.31 [(95%CI: 0.05, 1.79), p value = 0.189] in PP population [5] .
Publications
-
Synairgen. Data from SG016 Phase II Clinical Trial published in Lancet Respiratory Medicine. Media-Rel 2020;.
Media Release -
Synairgen. Synairgen announces data from Home Cohort of SG016 Phase II trial of inhaled interferon beta in COVID-19 patients and encouraging combined data for whole SG016 trial. Media-Rel 2021;.
Media Release -
Synairgen. Synairgen announces positive results from trial of SNG001 in hospitalised COVID-19 patients. Media-Rel 2020;.
Media Release -
Synairgen. Synairgen plc - Interim results for the six months ended 30 June 2020. Media-Rel 2020;.
Media Release
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Jody Brookes
Synairgen Research Ltd
show details
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/ |
Synairgen Research Limited | United-Kingdom |
| Nick Francis | Study Deputy Chief Investigator |
-
|
|
Sophie Hemmings
02380512800
show details
sophie.hemmings@synairgen.com https://www.synairgen.com/ |
Synairgen Research Limited | United-Kingdom |
| Tom Wilkinson | Study Chief Investigator |
-
|
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 |
| Oaks Healthcare | Waterlooville | United-Kingdom |
| Park and St Francis Surgery | Chandler's Ford | United-Kingdom |
| Queen Elizabeth Hospital, | Birmingham | United-Kingdom |
| Study Chief Investigator |
-
|
-
|
| Study Deputy Chief Investigator |
-
|
-
|
| Synairgen Research Limited |
-
|
United-Kingdom |
| The Adam Practice | Poole | United-Kingdom |
| The Virtual Team | Southampton | United-Kingdom |
| University Hospital Southampton Nhs Foundation Trust | Southampton | United-Kingdom |
| Wythenshawe Hospital | Manchester | United-Kingdom |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 05 Jan 2023 | Other trial event | Last checked against ClinicalTrials.gov: US National Institutes of Health record. Updated 05 Jan 2023 |
| 03 Jan 2023 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 05 Jan 2023 |
| 01 Jun 2021 | Other trial event | Last checked against ISRCTN: Current Controlled Trials record. Updated 01 Jun 2021 |
| 30 Apr 2021 | Other trial event | According to a Synairgen media release, the company plans to submit the findings for peer review at an upcoming medical conference or publication. Updated 07 May 2021 |
| 30 Apr 2021 | Results | Results from the home cohort and data from the combined analysis of the hospital and home cohorts, presented in a Synairgen media release. Updated 07 May 2021 |
| 23 Mar 2021 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
| 17 Mar 2021 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 26 Mar 2021 |
| 19 Jan 2021 | Other trial event | According to a Synairgen media release, this study has been conducted in collaboration of TranScrip Partners. Updated 17 Feb 2021 |
| 19 Jan 2021 | Other trial event | According to a Synairgen media release, the company announced that it has completed the recruitment of 120 COVID-19 patients into this study, conducted in the home setting. Results from the trial are expected in Q2 2021. Updated 17 Feb 2021 |
| 18 Dec 2020 | Other trial event | According to a Synairgen media release, after a slow start in the summer, recruitment and dosing are now progressing well with a noticeable increase in the last two months. Updated 24 Dec 2020 |
| 13 Nov 2020 | Other trial event | According to a Synairgen media release, Professor Tom Wilkinson (Professor of Respiratory Medicine at the University of Southampton) is the lead author. Updated 27 Nov 2020 |
| 13 Nov 2020 | Endpoint met | Primary endpoint has been met. (Change in clinical condition using the WHO Ordinal Scale for Clinical Improvement (OSCI) during the dosing period in the intention-to-treat population (ITT): pilot phase of inpatients) Updated 27 Nov 2020 |
| 13 Nov 2020 | Results | According to a Synairgen media release, results (n=101, pilot phase of inpatients) presented in The Lancet Respiratory Medicine journal. Updated 27 Nov 2020 |
| 13 Nov 2020 | Results | Results (n=101, pilot phase of inpatients) presented in a Synairgen media release. Updated 27 Nov 2020 |
| 29 Sep 2020 | Interim results | Interim results published in Synairgen media release Media Release. Updated 03 Nov 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 |
Table of Contents
References
-
Synairgen. Data from SG016 Phase II Clinical Trial published in Lancet Respiratory Medicine. Media-Rel 2020;.
Media Release -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Synairgen. Synairgen announces data from Home Cohort of SG016 Phase II trial of inhaled interferon beta in COVID-19 patients and encouraging combined data for whole SG016 trial. Media-Rel 2021;.
Media Release -
Synairgen. Synairgen announces positive results from trial of SNG001 in hospitalised COVID-19 patients. Media-Rel 2020;.
Media Release -
Synairgen. Synairgen plc - Interim results for the six months ended 30 June 2020. Media-Rel 2020;.
Media Release -
Synairgen. Synairgen announces completion of recruitment into its Phase II Home-Based COVID-19 study of inhaled interferon beta. Media-Rel 2021;.
Media Release -
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 -
Synairgen. National expansion of Synairgen's home-based COVID-19 trial of inhaled SNG001. Media-Rel 2020;.
Media Release -
ISRCTN: Current Controlled Trials. Trial-Reg 2023;.
Available from: URL: http://www.controlled-trials.com -
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Media Release -
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Media Release -
Synairgen. Result of General Meeting:Synairgen plc. Media-Rel 2020;.
Media Release -
Synairgen. Synairgen confirms commencement of dosing in trial of SNG001 in COVID-19. Media-Rel 2020;.
Media Release -
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 -
Synairgen. Synairgen Completes Recruitment of Hospitalised Patients in COVID-19 Trial. Media-Rel 2020;.
Media Release -
Synairgen. Synairgen to start trial of SNG001 in COVID-19 imminently. Media-Rel 2020;.
Media Release -
Synairgen. COVID-19 Clinical Programme Update. Media-Rel 2020;.
Media Release
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