Phase II trial of inhaled anti-viral (SNG001) for SARS-CoV-2 infection [COVID-19] [UPH]
Research type
Research Study
Full title
A randomised double-blind placebo-controlled trial to determine the safety and efficacy of inhaled SNG001 (IFNβ-1a for nebulisation) for the treatment of patients with confirmed SARS-CoV-2 infection
IRAS ID
281317
Contact name
Tom Wilkinson
Contact email
Sponsor organisation
Synairgen Research Limited
Eudract number
2020-001023-14
ISRCTN Number
ISRCTN14241621
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 16 days
Research summary
Summary of Research
SNG001 is an inhaled form (one that is breathed in through the nose) of interferon beta-1a (a drug used to treat multiple sclerosis). It contains a protein (interferon beta) which is made in the lungs during viral lung infections and which stops the growth of viruses. It has already been tested by a company called Synairgen in patients with chronic obstructive pulmonary disease (a type of lung disease causing long-term breathing problems). The purpose of this study is to confirm that SNG001 can prevent or reduce the worsening of lower respiratory tract illness (infection of the lungs) in patients with the SARS-CoV-2 virus (the virus that causes COVID-19). The drug’s safety and effectiveness will both be assessed. The study will include patients with COVID-19 infection who are at high risk (e.g. elderly or diabetics) whether in hospital or not. They will receive either SNG001 or placebo (treatment with no active ingredient) inhaled once daily for 14 days. Their general medical condition, levels of breathlessness, cough and sputum (mucus from the lungs) will be recorded every day, along with any safety information.
Summary of Results
Trial Title:
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 Number: SG016
This is a lay summary of the SG016 clinical trial results.
Synairgen Research Ltd is the sponsor of this trial and also funded the trial (Synairgen Research Ltd, Mailpoint 810, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, United Kingdom, Tel: +44 (0) 23 8051 2800, https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.synairgen.com%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7C792656fdc91f44bffaa708daf3f789fe%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638090541738798143%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=iD0dE0uc9j%2BjHN8%2F%2Bwx6y5TPLK5Xc9ee%2BPazoX4iMAQ%3D&reserved=0).Synairgen would like to share the overall results of the study with the research participants and the public.
Thank you!Synairgen would like to send a huge thank you to everyone who took part in this study, as well as their family and friends. SG016 took place in the early part of the COVID-19 pandemic when there was limited knowledge about the disease, an urgent need for new treatments, and the impact the virus was having on people was high. Despite this, participants in this study showed an incredible level of engagement and dedication to the trial in undertaking the required research activities.
We hope that this study summary can help all research participants understand and feel proud about their participation in the study.
This summary is for informational purposes only. If you need medical advice, please get in touch with your doctor. If you took part in this research study and have questions about the results, please speak with a doctor or nurse at the study site.
Why was the research needed?
SARS-CoV-2 was a new type of coronavirus identified in 2019 which causes the illness COVID-19 in people who become infected. In the early part of the COVID-19 pandemic, no drug treatments were proven to help patients, especially those that were admitted to hospital due to COVID-19.
Due to the nature of the disease and how easily it is spread, COVID-19 was and remains a global threat. There was and continues to be a need to assess new treatments which could prevent and effectively treat the lower respiratory tract (lung) illness caused by COVID-19.Interferon is a naturally occurring protein produced by the body which switches on the body’s anti-viral defences. Viruses inhibit the production of Interferon to avoid these anti-viral defences. SNG001, the treatment being studied, contains interferon and is given by nebuliser, an inhalation device, which gets the drug directly into the lungs. The aim of treatment is to increase the amount of interferon at the site of the infection, as that may have been reduced by the virus, to boost anti-viral defences to clear the virus.
Researchers wanted to see if SNG001 could be given as a treatment to patients with confirmed COVID-19 to prevent or limit the worsening of the COVID-19 illness.
Who participated in the study?
This study was split into two parts; the Hospital setting and the Home setting. Some patients were treated in hospitals, and some were treated in their homes. The Hospital setting group (101 patients) were aged over 18 and had been admitted to the hospital due to the severity of their COVID-19 illness. The Home setting group (120 patients) were over 50 years of age and had other health problems, such as high blood pressure or diabetes, but were not admitted to the hospital.All patients were confirmed to have the SARS-CoV-2 infection, after which they received either SNG001 or a placebo (dummy drug) for 14 days.
This research took place across multiple research sites in the UK, starting in March 2020 and finishing in November 2021.
What treatments or interventions did the participants take/receive?
Patients with confirmed COVID-19 infection received either SNG001 or placebo once a day for 14 days. The study medication was delivered to patients through a handheld nebuliser.Study visits for patients treated in the Hospital setting included a lung assessment, a check of vital signs (blood pressure, pulse and how fast you breathe), an ECG (heart reading), blood and sputum samples, adverse events, changes in medication and completion of a questionnaire relating to the patient’s symptoms.
Study visits for patients treated in the Home setting were conducted via a video or telephone call with a Study Doctor or Nurse. Assessments included a lung assessment, a check of vital signs, adverse events, changes in medication and completion of a questionnaire relating to the patient’s symptoms.
Study visits for patients in the Hospital setting occurred at Consent/Screening (this is done before you can join a study, you have to give permission to enter the study and checks are done to see if they were eligible to join the study) and on Day 1, then Days 2-14. A follow-up visit was completed 14 days after the end of treatment and one visit up to 18 months later to assess long COVID for those participants who were willing to take part.
For patients treated in the Home setting, visits (via video or telephone call) followed the same schedule as the hospital patients but had additional follow up visits on Days 60 and 90 to complete lung assessments and questionnaires, to check COVID-19 symptoms and assess long COVID for up to 12 months following day 90.
What medical problems (adverse events) did the participants have?
Hospital Setting:
There were a small number of medical events that were assessed by the study doctors to be related to SNG001 (7 out of 48 patients) or placebo (2 out of 50 patients). Medical events defined as serious were reported in 14.6% of patients receiving SNG001 and 28% of patients receiving placebo. All serious events when reviewed by study doctors were thought to be either ‘unlikely’ or ‘not related’ to SNG001 or placebo.Home Setting:
15 out of 56 patients receiving SNG001 and 15 out of 58 patients receiving placebo experienced medical events that were considered to be related to SNG001 or placebo.
Medical events defined as serious were reported in 7.1% of patients receiving SNG001 compared to 3.4% of patients receiving placebo. All serious events were assessed by study doctors to be either ‘unlikely’ or ‘not related’ to SNG001 or placebo.The overall conclusion for both the Hospital and Home settings was that SNG001 has a favourable safety profile and was well-tolerated in these trial populations.
What were the results of this study?
This is a summary of the main results from the Hospital and Home settings for this study. These are the results from all the participants combined. The individual results of each participant may vary but are not listed individually.Deciding which treatments work best usually takes results from several studies. Other studies may provide new information or different results. Always talk to a doctor before making any treatment decisions.
Results from the Hospital setting showed that SNG001 had a positive effect on patients. Patients who received SNG001 recovered faster than patients receiving placebo (the dummy drug). The results also suggested that it meant faster discharge from hospital and fewer patients developed severe disease or died, but this wasn’t proven. Patients dosed with SNG001 also had a much greater improvement in how breathless they felt.
Results from the Home setting showed that there was no proven difference in recovery between patients treated with SNG001 and placebo. We think this is because these patients had much milder symptoms, including the key symptom of breathlessness, than those treated in the hospital.
For both the Hospital and Home settings, the results showed SNG001 was well tolerated by patients with COVID-19, raising no safety concerns and that patients were able to administer the study medication using the nebuliser without the need for face-to-face contact.
The findings of this study suggests that SNG001 could potentially be used in treating patients admitted to hospital with COVID-19, although SNG001 should be explored further in a larger trial. There is clearly a need for more medication options for patients with COVID-19 and the results suggest that SNG001 might be effective in this setting, although our results require further investigation in future trials.
How has this research helped patients and researchers?
The results of this study have helped researchers understand more about how SNG001 might be able to be used to help patients with COVID-19. The results from this study have led to two further trials of SNG001 in COVID-19, the SPRINTER trial in hospitalised patients and the ACTIV-2 trial in patients treated in the home setting. Further research is needed to understand more about the use of SNG001 in patients with a respiratory viral infection.Where can I learn more about the study?
If you want to learn more about this study or about Synairgen Research, please use the links below:SG016 Publication, The Lancet Respiratory Medicine: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbTIv-2Ft3HPwp9ygyfRmTQm9UpaGu8o8Jpl2Akog49S2augpm0ckP1lW-2F01UzPLMqq2becPtdHjq2juOnvG4sV71NSNszCTDaO-2Bw8XXm1gNLAsHFrs_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJomyaactcTM-2Bmg0t7w0GzIj0drGGbp5meC1Ha3SRvxytFvi7HgaQzfdkY5-2BU4Am8HwnE1Qq9KSJwqlvUjAOOF06RVdWbtj-2BYYluyjWScIljOAMyPn5u-2B8dY4nC8ADbPJPIbZclSDsklS3LRMbSzPOY9JUngl1CNnvE5vOasCmulA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C792656fdc91f44bffaa708daf3f789fe%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638090541738798143%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=E%2Bz5wINDyCo7mOn0tUqVa1kdYS6PTRAUwFZGedKqlDI%3D&reserved=0
Synairgen Research Ltd: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbdEgv2L958AjlohfERqZQ13XZ0bfmw4iv5EcWQahoi-2BZAtRs_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJomyaactcTM-2Bmg0t7w0GzIkmRRfGsPcPjXsFqdTlURNNZq08q64no6wZwZ0M5RFvwquJaxKhMWZ-2BictFNfL3-2B1n11qWRzUxH9V1m3aiX4cveYeoc0kKKUfsj6GWbPR6-2FZio7ab6RuNJ5137wwJUCVWhURD6S9nXMYu927uN973lw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C792656fdc91f44bffaa708daf3f789fe%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638090541738798143%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=VwFe9d4MNu7H%2BevlAJZzTsFAQqnND0ELeMytpq9Q76s%3D&reserved=0
REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0168
Date of REC Opinion
17 Mar 2020
REC opinion
Further Information Favourable Opinion