Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 (COVID-19) Infection

Inclusion criteria

• 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.

• Male or female, ≥18 years of age (hospital setting) or ≥50 years of age (home setting) at the time of consent.
• 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
• Provide informed consent.
• 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.

Exclusion criteria

• > 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.
• ≥ 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).
• 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.
• 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.
• Ventilated or in intensive care.
• Inability to use a nebuliser with a mouthpiece.
• History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation.
• Females who are breast-feeding, lactating, pregnant or intending to become pregnant.