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Oct. 26, 2020, 7:26 a.m. eu

1. Subjects with a life expectancy of less than 6 months 2. No remaining available therapies for advanced or metastatic malignancies 3. Subjects with an advanced healthcare directive that includes a do not intubate (DNI) or do not resuscitate (DNR) orders. 5. Subjects who require chemotherapy due to active oncologic disease that cannot be suspended while receiving study treatment. 6. Subjects with new onset malignancy who require urgent systemic therapy because of active oncologic disease 7. Subjects who received systemic chemotherapy resulting in immunosuppression within 14 days of Cycle 1 Day 1. 8. Active treatment with immunomodulator medications including immune checkpoint inhibitors (PD-1, PD-L1, CTLA4 blockers) that could not be suspended for the duration of the study. 9. Subjects who received prior anti-cytokine therapy (anti-IL-6) within 5 half-lives of the drug from Cycle 1 Day 1. 10. Participation in another clinical study with therapeutic intent for COVID-19. The only exception is that patients participating in clinical trials receiving hydroxychloroquine or chloroquine and/or azithromycin and/or remdesivir will be allowed 11. Patients on warfarin at study entry 12. Patients on combined anti-platelet and therapeutic anti-coagulation therapy (LMWH or DOAC). 13. Myocardial infarct within 6 months, unstable angina, uncontrolled cardiac arrhythmia, or New York Heart Association (NYHA) class 3/4 heart failure 14. Requirement for artificial ventilation (HFNC, NiPPV, ECMO, or intubation and MV) at screening 15. Known bleeding disorders (e.g., Von Willebrand’s disease, platelet storage pool disorders, or hemophilia) 16. Stroke or intracranial hemorrhage within 6 months of Cycle 1 Day 1 17. Women who are pregnant or breastfeeding 18. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV) 20. Subjects with known history of human immunodeficiency virus (HIV) 21. Grade 2 or higher QTc prolongation (> 480 milliseconds per National Cancer Institute Common Terminology of Adverse Events [v 5.0]) 22. Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.) 23. Patients receiving radiation therapy to the lung or mediastinum for treatment of COVID-19 24. Untreated or actively progressing known CNS lesions (carcinomatous meningitis). Patients with a history of CNS lesions are eligible, provided that all of the following criteria are met: – All known CNS lesions have been treated with radiotherapy or surgery. – Any radiotherapy or surgery must be completed ≥ 4 weeks prior to initiation of study treatment. – No history of intracranial hemorrhage from CNS lesions

1. Subjects with a life expectancy of less than 6 months 2. No remaining available therapies for advanced or metastatic malignancies 3. Subjects with an advanced healthcare directive that includes a do not intubate (DNI) or do not resuscitate (DNR) orders. 5. Subjects who require chemotherapy due to active oncologic disease that cannot be suspended while receiving study treatment. 6. Subjects with new onset malignancy who require urgent systemic therapy because of active oncologic disease 7. Subjects who received systemic chemotherapy resulting in immunosuppression within 14 days of Cycle 1 Day 1. 8. Active treatment with immunomodulator medications including immune checkpoint inhibitors (PD-1, PD-L1, CTLA4 blockers) that could not be suspended for the duration of the study. 9. Subjects who received prior anti-cytokine therapy (anti-IL-6) within 5 half-lives of the drug from Cycle 1 Day 1. 10. Participation in another clinical study with therapeutic intent for COVID-19. The only exception is that patients participating in clinical trials receiving hydroxychloroquine or chloroquine and/or azithromycin and/or remdesivir will be allowed 11. Patients on warfarin at study entry 12. Patients on combined anti-platelet and therapeutic anti-coagulation therapy (LMWH or DOAC). 13. Myocardial infarct within 6 months, unstable angina, uncontrolled cardiac arrhythmia, or New York Heart Association (NYHA) class 3/4 heart failure 14. Requirement for artificial ventilation (HFNC, NiPPV, ECMO, or intubation and MV) at screening 15. Known bleeding disorders (e.g., Von Willebrand’s disease, platelet storage pool disorders, or hemophilia) 16. Stroke or intracranial hemorrhage within 6 months of Cycle 1 Day 1 17. Women who are pregnant or breastfeeding 18. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV) 20. Subjects with known history of human immunodeficiency virus (HIV) 21. Grade 2 or higher QTc prolongation (> 480 milliseconds per National Cancer Institute Common Terminology of Adverse Events [v 5.0]) 22. Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.) 23. Patients receiving radiation therapy to the lung or mediastinum for treatment of COVID-19 24. Untreated or actively progressing known CNS lesions (carcinomatous meningitis). Patients with a history of CNS lesions are eligible, provided that all of the following criteria are met: – All known CNS lesions have been treated with radiotherapy or surgery. – Any radiotherapy or surgery must be completed ≥ 4 weeks prior to initiation of study treatment. – No history of intracranial hemorrhage from CNS lesions