Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19
Condition: Severe Acute Respiratory Syndrome Coronavirus 2; COVID-19
MeSH terms: COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome
Intervention: SNG001; Placebo
Intervention description: SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day; Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: The study will be patient and investigator-blinded with regard to SNG001 or placebo but not the dose.
Enrollment: 623.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronavirus disease-2019 (COVID-19); Interferon beta

Summary:

      The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of
      hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome
      coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to hospital due to the severity of their COVID-19

          -  Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay.
             Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be
             randomised no later than 48 hours after hospital admission. If the virus test is
             performed more than 96 hours prior to hospitalisation, the test will have to be
             repeated in the hospital prior to randomisation. Only patients whose repeated virus
             test is positive will be randomised, no later than 48 hours after confirmation of
             SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2
             after hospitalisation will be randomised no later than 48 hours after confirmation of
             SARS-CoV-2 infection

          -  Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)

          -  Provided informed consent

          -  Female patients must be ≥1 year post-menopausal, surgically sterile, or using a
             protocol defined highly effective method of contraception

          -  Women of child bearing potential should have been stable on their chosen method of
             birth control for a minimum of 3 months before entering the trial and should continue
             with birth control for 1 month after the last dose of inhaled interferon-β
             (IFN-β1a)/matching placebo. In addition to the highly effective method of
             contraception (except for the practice of total sexual abstinence), a condom (in
             United Kingdom with spermicides) should be used by the male partner for sexual
             intercourse from randomisation (Visit 2) and for 1 month after the last dose of
             inhaled IFN-β1a/matching placebo to prevent pregnancy

          -  Women not of childbearing potential are defined as women who are either permanently
             sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who
             are postmenopausal. Women will be considered post-menopausal if they have been
             amenorrhoeic for 12 months prior to the planned date of randomisation without an
             alternative medical cause. The following age specific requirements apply: women <50
             years old will be considered post-menopausal if they have been amenorrhoeic for 12
             months or more following cessation of exogenous hormonal treatment and if follicle
             stimulating hormone (FSH) levels are in the postmenopausal range; women ≥50 years old
             will be considered post-menopausal if they have been amenorrhoeic for 12 months or
             more following cessation of all exogenous hormonal treatment. If, in the setting of
             the pandemic, the use of an acceptable birth control method is not possible, the
             decision to enrol a woman of childbearing potential should be based on the
             benefit-risk for the patient, which should be discussed with the patient at the time
             of the informed consent.

        Exclusion Criteria:

          -  Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a
             validated molecular assay or validated antigen assay

          -  Non-invasive ventilation continuous positive airway pressure/bilevel positive airway
             pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)

          -  Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of ≥6) or
             admission to intensive care

          -  Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated
             antigen assay

          -  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

          -  Participation in previous clinical trials of SNG001

          -  Current or previous participation in another clinical trial where the patient has
             received a dose of an Investigational Medicinal Product 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

          -  Inability to use a nebuliser with a mouthpiece

          -  Inability to comply with the requirements for storage conditions of study medication
             in the home setting

          -  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.