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

Inclusion Criteria:

- Hospitalized patient with clinical diagnosis of SARS-CoV-2 virus infection per World
Health Organization criteria including positive nucleic acid test of any specimen
(e.g., respiratory, blood, or other bodily fluid) within 2 weeks prior to screening.

- Symptoms suggestive of severe systemic illness with COVID-19, which could include any
of the following symptoms: fever, cough, sore throat, malaise, headache, muscle pain,
gastrointestinal symptoms, or shortness of breath at rest, or respiratory distress.

- Clinical signs indicative of severe systemic illness with COVID-19, which could
include any of the following clinical signs: respiratory rate ≥ 30 per minutes, heart
rate ≥ 125 per minute, SpO2 ≤ 93% on room air, or PaO2/FiO2 ratio < 300 mmHg.

- Men or women ≥18 but ≤80 years of age at the time of signing the informed consent.

- Patient is able to understand the purpose and risks of the study and provide signed
and dated informed consent or have a legal representative provide consent and
authorization to use protected health information (in accordance with national and
local patient privacy regulations).

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