Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs,

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs,

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhib

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhib

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhib

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhib

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization. 20. Active participation in other drug clinical trials or received treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization/en

Subjects are excluded from the study if any of the criteria below apply. COVID-19 Related Medical Conditions 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory failure) due to COVID-19 pneumonia. 2. Known medical resuscitation within 14 days of randomization. 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator´s judgment, precludes the subject’s safe participation in and completion of the study. 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). 5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. Medical Conditions 6. Not expected to survive 28 days given their preexisting, uncorrectable medical condition, for example, subjects with, or suspected to have, the following conditions: multiorgan failure, poorly controlled neoplasms, endstage cardiac disease, cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within past 30 days, endstage lung disease, endstage liver disease, or human immunodeficiency virus/acquired immunodeficiency syndrome with known endstage process. 7. Pregnant or breast feeding. 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin &#8805, 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C, see Appendix G) detected within 24 hours at screening (per local laboratory). 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory). 10. Platelet count < 50,000/µL at screening (per local laboratory). 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female]. 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study. 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. 14. Quadriplegia. 15. History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. 16. Known active hepatitis B or C infection requiring therapy. Prior/Concomitant Therapy 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). 18. Requires treatment with proton-pump inhibitors (PPIs, eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before randomization. 20. Active participation in other drug clinical trials or received treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization/en