Created at Source Raw Value Validated value
July 16, 2021, 11:30 p.m. eu

1. Patient not committed to aggressive management. For example, the subject, the subject's family or primary physician are unwilling to accept that the subject is placed on mechanical ventilation, or in the case of an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation. 2. A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19). 3. Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times the upper limit of normal (ULN) detected at screening (per local lab) or suspected liver disease. 4. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure. 5. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 6. Clinically verified pulmonary embolism 7.Chronic inflammatory disease requiring treatment with oral corticosteroids in a dose higher than prednisone 10 milligrams (mg) or equivalent per day, or requiring treatment with other anti-inflammatory drugs (e.g. methotrexate). 8. Use of strong CYP3A4 inhibitors (e.g. azoleantifungals, macrolide antibiotics, protease inhibitors) or inducers (e.g. rifabutin and rifampicin) and drugs sensitive to CYP3A4 inhibition (e.g. benzodiazepines, certain statins [lovastatin and simvastatin], certain P2Y12 inhibitors [ticagrelor and clopidogrel]). 9. Participation in another pharmaceutical clinical study. 10. Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP). 11. Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or ICU admission for any other cause than respiratory support. 12. Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons. 13. Active malignancy with or without treatment, except local basal cell carcinoma.

1. Patient not committed to aggressive management. For example, the subject, the subject's family or primary physician are unwilling to accept that the subject is placed on mechanical ventilation, or in the case of an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation. 2. A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19). 3. Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times the upper limit of normal (ULN) detected at screening (per local lab) or suspected liver disease. 4. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure. 5. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 6. Clinically verified pulmonary embolism 7.Chronic inflammatory disease requiring treatment with oral corticosteroids in a dose higher than prednisone 10 milligrams (mg) or equivalent per day, or requiring treatment with other anti-inflammatory drugs (e.g. methotrexate). 8. Use of strong CYP3A4 inhibitors (e.g. azoleantifungals, macrolide antibiotics, protease inhibitors) or inducers (e.g. rifabutin and rifampicin) and drugs sensitive to CYP3A4 inhibition (e.g. benzodiazepines, certain statins [lovastatin and simvastatin], certain P2Y12 inhibitors [ticagrelor and clopidogrel]). 9. Participation in another pharmaceutical clinical study. 10. Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP). 11. Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or ICU admission for any other cause than respiratory support. 12. Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons. 13. Active malignancy with or without treatment, except local basal cell carcinoma.

Feb. 2, 2021, 4:49 p.m. eu

1. Patient not committed to aggressive management. For example, the subject, the subject's family or primary physician are unwilling to accept that the subject is placed on mechanical ventilation, or in the case of an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation. 2. A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19). 3. Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times the upper limit of normal (ULN) detected at screening (per local lab) or suspected liver disease. 4. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure. 5. Repeated (>2) episodes of diarrhea during the last 24 hours before randomization. 6. Clinically suspected and verified pulmonary embolism 7. Chronic treatment of inflammatory disease (e.g. oral corticosteroids). 8. Use of strong CYP3A4 inhibitors (e.g. azoleantifungals, macrolide antibiotics, protease inhibitors) or inducers (e.g. rifabutin and rifampicin) and drugs sensitive to CYP3A4 inhibition (e.g. benzodiazepines, certain statins [lovastatin and simvastatin], certain P2Y12 inhibitors [ticagrelor and clopidogrel]). 9. Participation in another pharmaceutical clinical study. 10. Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP). 11. Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or ICU admission for any other cause than respiratory support. 12. Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons. 13. Active malignancy with or without treatment, except local basal cell carcinoma.

1. Patient not committed to aggressive management. For example, the subject, the subject's family or primary physician are unwilling to accept that the subject is placed on mechanical ventilation, or in the case of an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation. 2. A suspected, active bacterial, fungal, viral, or other infection (besides COVID 19). 3. Alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) > 2 times the upper limit of normal (ULN) detected at screening (per local lab) or suspected liver disease. 4. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or decompensated congestive heart failure. 5. Repeated (>2) episodes of diarrhea during the last 24 hours before randomization. 6. Clinically suspected and verified pulmonary embolism 7. Chronic treatment of inflammatory disease (e.g. oral corticosteroids). 8. Use of strong CYP3A4 inhibitors (e.g. azoleantifungals, macrolide antibiotics, protease inhibitors) or inducers (e.g. rifabutin and rifampicin) and drugs sensitive to CYP3A4 inhibition (e.g. benzodiazepines, certain statins [lovastatin and simvastatin], certain P2Y12 inhibitors [ticagrelor and clopidogrel]). 9. Participation in another pharmaceutical clinical study. 10. Subject who has received any investigational drug within the last 3 months before administration of the investigational medicinal product (IMP). 11. Severe COVID-19 at randomization: requiring non-invasive or invasive mechanical ventilation or ICU admission for any other cause than respiratory support. 12. Patients judged not to be suitable for non-invasive monitoring of oxygen saturation because of impaired peripheral circulation or for other reasons. 13. Active malignancy with or without treatment, except local basal cell carcinoma.