Safety and Tolerability Study of IV ST266 in COVID-19 Subjects

Exclusion Criteria

• •1. Subjects requiring immediate admission to the hospital due to complications of COVID-19 infection.
• •2. Subject has an untreated active bacterial, fungal, viral or other infection not related to COVID-19 infection.
• •3. Subjects with chronic lung diseases of any etiology including idiopathic pulmonary fibrosis, Tuberculosis, COPD, persistent asthma, and pulmonary hypertension.
• •4. Subjects with a severe history of cardiac disease (such as congestive heart failure, coronary artery disease, cardiac arrhythmia)
• •5. Subjects with a history of neurological disorders (such as epilepsy, stroke, encephalopathy, Guillain-Barré syndrome)
• •6. Subjects with D-dimer \> 2 ug/mL
• •7. Subjects with a history of coagulopathy or currently taking anti-coagulation medication
• •8. Subjects with PTT ≥ 100s or INR ≥ 2.75
• •9. Malignancy in the last 5 years (except successfully treated basal cell carcinoma).
• •10. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR \< 30).
• •11. Subjects with a reactive or positive screening test result For Hepatitis A virus immunoglobulin M (HAV IgM), Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus Antibody (HCVAb) or Human Immunodeficiency Virus Antibody (HIVAb).
• •12. TBIL\> 2×ULN, ALT \> 3×ULN, AST\> 3×ULN, or ALP\> 3×ULN.
• •13. Neutrophils \<1000/mm3, PLT\<50×10\^9/L, or HGB\<8g/dL
• •14. Previous participation in any other interventional clinical trial for the treatment for COVID-19.
• •15. Subject actively participating in any other clinical study (with the exception of observational studies where there is no intervention with an investigational product or device)
• •16. Use of anti-cancer or immunomodulatory biological drug or kinase inhibitor (e.g., tocilizumab, sarilumab) or, JAK inhibitors (within 30 days of enrollment or five times the half-life \[whichever is longer\]).
• •17. Chronic glucocorticosteroid use equivalent to daily oral prednisone \> 10 mg per day (10 mg oral prednisone every other day is allowed).
• •18. Live (live-attenuated) vaccines are not permitted within 2 weeks prior to enrollment or during the study treatment and safety follow-up periods, including the SARS-CoV-2 vaccine (with the exception of the Flu vaccine which is allowed at any time)
• •19. Subject is pregnant or breastfeeding or plans to become pregnant within 12 months.
• •20. Subjects with a history of alcohol or drug abuse, or the use of illicit drugs within the 12 months prior to Screening or use of medical marijuana within 1 month prior to Screening.
• •21. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.