Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness

Inclusion Criteria:

Age

1. Are ≥18 years of age at the time of randomization

   Disease Characteristics
2. Are currently hospitalized since less or equal than 3 days for COVID-19 respiratory illness
3. Must have a positive SARS-CoV-2 viral infection determination prior to randomisation. For the phase 2 portion of the study only, the test must be performed within 24 hours before randomisation. Test can be a PCR or an antigen test originated from the institution or any government approved testing site. If the original test result is greater than 24 hours from randomisation, a rapid antigen must be performed at bedside by the study team to determine eligibility

   Sex
4. Are men or non-pregnant women Reproductive and Contraceptive agreements and guidance is provided in Appendix 2. Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies.

   Study Procedures
5. Understand and agree to comply with planned study procedures
6. Agree to the collection of nasopharyngeal swabs and venous blood

   Informed Consent
7. The participant or legally authorized representative give signed informed consent

   Exclusion Criteria:

   Medical Conditions
8. COVID-19 onset of symptoms began more than 10 days before randomisation
9. Currently intubated or intubation is planned within the next 24 hours
10. Have known allergies to any of the components used in the formulation of the interventions
11. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
12. Have any co-morbidity requiring surgery within \<7 days, or that is considered life- threatening within 29 days
13. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.

    Other Exclusions
14. Have received treatment with a SARS-CoV-2 specific monoclonal antibody
15. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
16. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
17. Are pregnant or breast feeding
18. Are investigator site personnel directly affiliated with this study