A Phase II Study in Patients With Moderate to Severe ARDS Due to COVID-19

Inclusion Criteria:

• Laboratory-confirmed diagnosis of COVID-19 <= 14 days prior to randomization
• The presence of moderate to severe Acute Respiratory Distress Syndrome (ARDS) asdefined by the Berlin Definition:

1. Bilateral chest radiograph infiltrates.
2. PaO2:FiO2 ratio of less than 200.
3. Absence of other clinical conditions that could present in a similar manner (non-infectious pneumonitis, cardiogenic pulmonary edema)

• Absence of moribund state that would indicate imminent demise and poor chance ofsurvival.

Exclusion Criteria:

• Females of childbearing potential who are pregnant or unwilling to undergo pregnancytesting; females with a positive pregnancy test on screening day will be excluded.
• Breastfeeding mothers
• Patients on ECMO
• Receiving concurrent treatment with an investigational agent in a clinical trial.
• Exception: Use of COVID-19 convalescent plasma is permitted.
• More than 72hrs on mechanical ventilation before randomization
• Receiving concurrent investigational vaccine