Overview

SNG001 is an inhaled drug that contains a antiviral protein called interferon beta (IFN-). IFN- in produced in the lungs during viral lung infections. It has been shown that older people and people with some chronic diseases have an IFN- deficiency. Many viruses inhibit IFN- as part of their strategy to evade the immune system.

Addition of IFN- in vitro protects lung cells from viral infection. IFN- protects cells against the MERS and SARS coronaviruses (close relatives of SARS-CoV-2, the virus that causes COVID-19).

SNG001 is an inhaled formulation of interferon beta-1a it is currently in Phase II clinical trials for COPD patients.

Synairgen has conducted randomised placebo controlled clinical trials of SNG001 involving >200 asthma and COPD patients. These trials have shown that SNG001 has:

• been well tolerated during virus infections
• enhanced antiviral activity in the lungs (measured in sputum and blood samples)
• provided significant lung function benefit over placebo in asthma in two Phase II trials.

Synairgen believes SNG001 could help prevent worsening or accelerate recovery of severe lower respiratory tract illness in COVID-19 patients.

Patients who are in hospital or non-hospitalised but are a high risk groups (e.g. elderly or diabetics) will be invited to take part in the trial. The patient would receive either SNG001 or placebo once daily for 14 days. The severity of the patients condition would be recorded on a scale developed by the World Health Organisation and the patient would be asked questions about their breathlessness, cough and sputum every day, as well as assess their general medical condition and safety.

If SNG001 proves to be beneficial it would be a major breakthrough for the treatment of COVID-19.

Eligibility

Inclusion Criteria:

1. 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
2. Male or female, 18 years of age at the time of consent
3. Patients admitted to hospital due to the severity of their confirmed or suspected COVID-19 disease OR non-hospitalised patients from high-risk co-morbidity groups such as the >65-years of age, or those with hypertension, cardiovascular disease, diabetes, a chronic lung condition, cancer, or frontline healthcare workers. (The Sponsor will inform sites as to whether non-hospitalised patients are to be entered into the trial).
4. Provide informed consent.
5. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception.

Exclusion Criteria:

1. > 24 hours after confirmation of SARS-CoV-2 infection by RT-PCR test
2. 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.
3. Current or previous participation in another clinical trial where the patient has received a dose of an 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.
4. Ventilated or in intensive care
5. Inability to use a nebuliser with a mouthpiece.
6. History of hypersensitivity to natural or recombinant IFN- or to any of the excipients in the drug preparation.
7. Patients that are taking an antiviral treatment (e.g. zanamivir or oseltamivir) prior to randomisation and/or on the day of randomisation
8. Female who are breast-feeding, lactating, pregnant or intending to become pregnant.