Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19

Inclusion Criteria: Inclusion Criteria:

1. Signed informed consent form by any patient capable of giving consent, or, when thepatient is not capable of giving consent, by his or her legal/authorizedrepresentatives prior to initiation of any study procedures.
2. Men and women, ≥18 years of age at time of enrollment.
3. Laboratory-confirmed diagnosis of SARS-CoV-2 infection as determined by PCR, or otherhealth authority-approved commercial assay or other validated public health assay inany specimen within 72 hours prior to randomization (point-of-care viral infectiontest allowable if RT-PCR test result not available only at the time of screening).
4. Less than or equal to 9 days from COVID-19 symptom onset to starting treatment. • Symptoms are defined as one or more of the following: cough, fever, shortness ofbreath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches,weakness/fatigue, chills/sweating, headache, confusion, sore throat, runnynose/congestion, loss of taste or smell, or any other COVID-19 symptoms as determinedby the Investigator.
5. Hospitalized and i) requiring supplemental oxygen by face mask or nasal prongs, or ii)non-invasive ventilation or iii) high-flow oxygen (WHO category 4 or 5)
6. Female patients participating in this study must agree to avoid becoming pregnant andhave a negative pregnancy test prior to randomization. Male and female patients ofreproductive potential must use a highly effective, protocol-specified method ofcontraception during the study and up to post 30 days after the last dose of studydrug. For a list of protocol-specified contraceptive methods, and the definition ofreproductive potential, refer to Appendix 1.

Exclusion Criteria: Exclusion Criteria:

1. Known hypersensitivity or intolerance to Interferon (IFN) or Novaferon or anyexcipient(s) of Novaferon, including pre-existing allergy or hypersensitivity toampicillin.
2. Currently undergoing invasive mechanical ventilation (including venous ECMO).
3. Inability to use a nebulizer with a mouthpiece.
4. ALT/AST > 5 times the Upper Limit of Normal (ULN) or a history of decompensatedcirrhosis.
5. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min/ 1.73m2).
6. In the opinion of the Investigator, progression to death is imminent and inevitablewithin the next 48 - 72 hours, irrespective of the provision of treatment.
7. In the opinion of the Investigator, progression to mechanical ventilation is imminentand inevitable within the next 24 hours, irrespective of the provision of treatment.
8. Possibility of the patient being discharged from hospital within 24 hours.
9. Concurrent participation in other anti-COVID-19 therapeutic or interventional trials.Patients may, at the discretion of the Investigator, concurrently participate in othernon-interventional COVID-19 studies.
10. Prior or concurrent use of experimental antiviral therapy for COVID-19 (see Appendix
12. Prior or concurrent use of any interferons other than the investigational product (seeAppendix 2)
13. Other known active infections or other clinical conditions (e.g., severe chronicobstructive pulmonary disease) that contraindicate aerosolized inhalation.
14. Patients with current or prior psychiatric illness, seizure disorders, retinalautoimmune disorders, pre-existing severe cardiovascular disease, or patients withprior transplants.
15. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
16. The subject has any medical condition that in the opinion of the investigator wouldcompromise subject's safety or compliance with study procedures.