A phase 2, two-part study to assess the safety, antiviral biomarker responses, and efficacy of inhaled SNG001 for the treatment of patients with a confirmed respiratory virus infection undergoing invasive mechanical ventilation

Lower respiratory tract viral infections

Part 1: The occurrence and severity of adverse events (AEs), and serious adverse events (SAEs), including pre-specified respiratory and cardiovascular deteriorations., Part 2: All-cause mortality within 28 days from randomisation.

1. Part 2: The occurrence and severity of AEs and SAEs, including pre-specified respiratory and cardiovascular deteriorations., 2. Part 2: Change from baseline in modified Sequential Organ Failure Assessment (mSOFA) score during ICU stay., 3. Part 2: Time to extubation., 4. Part 2: Ventilator-free days over 28 days from randomisation., 5. Part 2: Duration of ICU stay., 6. Part 2: Duration of hospital stay., 7. Part 2: All-cause mortality within 28 days post final dose., 8. Part 2: Alive and free of organ support at 28 days from randomisation and at 28 days post final dose., 9. Part 2: Change in Ordinal Scale for Clinical Improvement (OSCI) score from baseline to 7, 10, 14, and 28 days post randomisation., 10. Part 2: Time to first negative virus test in tracheal aspirates., 11. Part 2: Change from baseline in levels of IFNβ dependent biomarkers in tracheal aspirates.

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