Phase III trial of inhaled anti-viral (SNG001) for SARS-CoV-2 [COVID-19] [UPH]
Research type
Research Study
Full title
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
IRAS ID
290965
Contact name
Tom Wilkinson
Contact email
Sponsor organisation
Synairgen Research Limited
Eudract number
2020-004743-83
ISRCTN Number
ISRCTN85436698
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Summary of Research
Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2) is a global threat and there is a need to assess new treatments which will prevent and effectively treat severe lower respiratory tract (LRT) illness caused by the SARSCoV-2.Cytokines are a category of small proteins that are important in cell signalling. A certain cytokine called Interferon beta (IFN-β) has showed antiviral activity against SARS-CoV-2. IFN-β driven anti-viral responses have been shown to be compromised/deficient in older people and those with certain co-morbidities. Furthermore SARS-CoV-2 supresses the production of IFN-β. SNG001 is an inhaled IFN-β1a formulation and by delivering it directly into the lungs by aerosol it is possible to restore/boost anti-viral activity in the lungs. This has been shown in four clinical trials of SNG001 involving over 280 patients.
A pilot study of SNG001 was completed in May 2020. During this study, 101 hospitalised adults, ≥18 years of age, with confirmed or suspected SARS-CoV-2 infection were randomised to receive either SNG001 or placebo. Results of the pilot study showed that the odds of developing severe disease were markedly reduced in patients receiving SNG001 compared to placebo. Patients who received SNG001 were more than twice as likely to recover to ‘no limitation of activities’ from COVID-19 as those on placebo. In addition, there was a significant reduction in breathlessness in patients receiving SNG001, compared to placebo.
The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery to ‘no limitation of activities’ of hospitalised patients receiving oxygen with confirmed SARS-CoV-2. Safety and other efficacy endpoints will also be assessed.
Summary of Results
: Results showed that SNG001 and placebo had a similar effect on the time to going home or getting better in patients treated in the hospital. However, treatment with SNG001 on top of standard of care may have prevented progression to severe disease, but this wasn’t proven.
Patients receiving SNG001 also developed fewer new COVID-19 symptoms.
The results showed SNG001 was well tolerated by patients who have been hospitalised with SARS-CoV-2.
There is clearly a need for additional medication options for patients with COVID-19. The results of this trial suggest that SNG001 could potentially be used in treating patients admitted to hospital with COVID-19 and provides a strong clinical rationale for further investigation.REC name
London - Riverside Research Ethics Committee
REC reference
20/HRA/5234
Date of REC Opinion
9 Nov 2020
REC opinion
Further Information Favourable Opinion