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
Funder: SYNAIRGEN RESEARCH LIMITED
Sponsor: SYNAIRGEN RESEARCH LIMITED
CI: Professor Tom Wilkinson, University Hospital Southampton NHS Foundation Trust
Approval Date: 30 March 2020
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.
The purpose of this study is to confirm that SNG001 can prevent/limit the worsening of LRT illness in the context of SARS-CoV-2. Safety and efficacy will be assessed.
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SG016 Home Study
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 (SG016 Home Study)
Funder: not available
Sponsor: Synairgen Research Limited
CI: Professor Tom Wilkinson
Approval Date: 13 January 2021
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 SARS-CoV-2. Interferon beta (IFN-β) driven anti-viral responses have been shown to be compromised/deficient in older people1 and those with chronic airways diseases2,3. These, and other patient groups are at high risk of developing severe LRT illness which can be fatal4. The IFN-β deficiency can be overcome or boosted through the administration of exogenous IFN β. This has been shown both in vitro, using cells from patients, and in clinical trials using SNG001 (an inhaled IFN-β1a formulation for nebulisation) delivered via a breath actuated nebuliser. We hypothesise that SNG001 will rectify the deficiency in the lungs in at-risk patients and prevent severe LRT illness in the context of SARS-CoV-2 infection. SNG001 has been shown to inhibit a broad range of viruses in cell-based assays. Of particular relevance, SNG001 has been shown to inhibit viral shedding following MERS-CoV infection in cell-based assays, with a similar potency to that reported in the literature and against other virus types. In all clinical trials conducted to date (including 3 completed trials in asthma and one ongoing trial in chronic obstructive pulmonary disease [COPD]), inhaled SNG001 has upregulated lung antiviral biomarkers in sputum for 24 hours after dosing, confirming successful delivery of biologically active drug to the lungs, demonstrating proof-of-mechanism, and supporting dose selection. SNG001 has been well tolerated in all clinical studies to date. Around 230 patients have been treated with SNG001, of whom around 85% were asthma or COPD patients with an active respiratory viral infection (rhinovirus, influenza, coronavirus etc). SNG001 is pH neutral, rather than acidic. A low pH is known to trigger cough. In Phase II trials in asthmatics, cough occurred in <10% of patients and the incidence was no different to that seen with placebo. SNG001 does not contain excipients such as mannitol, human serum albumin (HAS) and arginine, which are present in the injectable IFN-β formulations. SNG001 is delivered using either the I-neb or Ultra nebuliser made by Philips Respironics and Aerogen, respectively. Both devices have been tested to ensure the drug retains its activity after aerosolization. A dose escalating trial established a target lung dose which induced an antiviral response in the lungs that was present 24 hours after dose administration. We propose to promptly treat patients with confirmed SARS-CoV-2 infection with SNG001 to prevent/reduce the severity of LRT illness. Initially, in the pilot phase of the study, 100 hospitalised patients and 120 ambulatory patients will be randomised to receive SNG001 or placebo on a 1:1 basis. A confirmatory/pivotal phase in the hospital and/or home settings may follow on from the pilot phase. The decision to go ahead with the pivotal phase will be determined after the data review at the end of the pilot phase. The primary endpoint is prevention of severe LRT illness as determined by step movement within the 9-point Ordinal Scale for Clinical Improvement. The appropriateness of this endpoint will be assessed by a blinded steering committee at the end of the pilot phase and will be changed if needed for the pivotal phase. Demonstration of efficacy would support the use of SNG001 to treat and prevent development of severe LRT illness due to SARS-CoV-2.
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