A Study of Opaganib in Coronavirus Disease 2019 Pneumonia

Exclusion Criteria

• •1. Any co-morbidity that may add risk to the treatment in the judgement of the investigator.
• •2. Requiring intubation and mechanical ventilation
• •3. Patient having a do not intubate or do not resuscitate order
• •4. Oxygen saturation \>95% on room air
• •5. Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
• •6. Patient is, in the investigator's clinical judgment, unlikely to survive \>72 hours
• •7. Pregnant or nursing women
• •8. Unwillingness or inability to comply with procedures required in this protocol.
• •9. Corrected QT (QTc) interval on electrocardiogram (ECG) \>470 ms for females or \>450 ms for males, calculated using Friedericia's formula (QTcF)
• •10. AST (SGOT) or ALT (SGPT) \> 2.5 x upper limit of normal (ULN)
• •11. Bilirubin \>2.0 x ULN (except where bilirubin increase is due to Gilbert's Syndrome)
• •12. Serum creatinine \>2.0 X ULN
• •13. Absolute neutrophil count \<1000 cells/mm3
• •14. Platelet count \<75,000/mm3
• •15. Hemoglobin \<8.0 g/dL
• •16. Currently taking medications that are sensitive CYP3A4, CYP1A2, CYP2C9, or CYP2C19 or CYP2D6 substrates and have a narrow therapeutic index. These should be decided in discussion with the Medical Monitor on a case-by-case basis.
• •17. Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4. These should be decided in discussion with the Medical Monitor on a case-by-case basis.
• •18. Currently taking warfarin, apixaban, argatroban or rivaroxaban.
• •19. Current drug or alcohol abuse.
• •20. Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies.