A Pilot Study to Assess Safety and Efficacy of SIR1-365 in Patients With Severe COVID-19

Exclusion Criteria

• •Patient requires endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \>20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO), or clinical diagnosis of respiratory failure.
• •Patient with shock defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressor.
• •Patient with multi-organ dysfunction or failure defined by an increase in the Sequential Organ Failure Assessment score of 2 points or more.
• •Patient is unlikely to survive beyond 2 days at the discretion of Investigator.
• •Patient has used chronic systemic corticosteroids within 2 weeks prior to screening.
• •Patient with positive results for human immunodeficiency virus (HIV) or hepatitis B or C test.
• •Patient has known active tuberculosis (TB), history of uncontrolled TB, suspected or known systemic bacterial or fungal infections within 4 weeks prior to screening.
• •Patient has any other condition, which makes the patient unsuitable for study participation