Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. patient's clinical condition is worsening rapidly. 2. requiring icu admission or ventilator support at screening or at randomization. 3. suspected bacterial, fungal, viral, or other infection (besides covid-19). 4. history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. 5. history of hypertension should have hypertension adequately controlled (bp \< 140/90 mmhg) with appropriate anti-hypertensive treatment. 6. clinically significant cardiac conduction abnormalities, including qtc prolongation of \> 450 milliseconds 7. family history of long qt syndrome. 8. heart failure class 3, or 4, as defined by the new york heart association (nyha). 9. history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. patients with implanted defibrillators or permanent pacemakers. 11. poorly controlled diabetes mellitus with an hba1c \> 7.5 %. 12. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. 13. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) \< 45 ml/min/1.73m2. 14. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. 15. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. 17. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. known hepatitis b or c infection. 19. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. alanine transaminase (alt) or aspartate transaminase (ast) \>3.0 x uln. 21. total bilirubin \>1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). 22. taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9. 23. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. 24. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. 25. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. known allergy or hypersensitivity to the imp (including excipients). 27. study participant is pregnant or breastfeeding. 28. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

1. patient's clinical condition is worsening rapidly. 2. requiring icu admission or ventilator support at screening or at randomization. 3. suspected bacterial, fungal, viral, or other infection (besides covid-19). 4. history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. 5. history of hypertension should have hypertension adequately controlled (bp \< 140/90 mmhg) with appropriate anti-hypertensive treatment. 6. clinically significant cardiac conduction abnormalities, including qtc prolongation of \> 450 milliseconds 7. family history of long qt syndrome. 8. heart failure class 3, or 4, as defined by the new york heart association (nyha). 9. history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. patients with implanted defibrillators or permanent pacemakers. 11. poorly controlled diabetes mellitus with an hba1c \> 7.5 %. 12. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. 13. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) \< 45 ml/min/1.73m2. 14. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. 15. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. 17. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. known hepatitis b or c infection. 19. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. alanine transaminase (alt) or aspartate transaminase (ast) \>3.0 x uln. 21. total bilirubin \>1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). 22. taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9. 23. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. 24. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. 25. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. known allergy or hypersensitivity to the imp (including excipients). 27. study participant is pregnant or breastfeeding. 28. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

Nov. 16, 2021, 6:30 p.m. usa

patient's clinical condition is worsening rapidly. requiring icu admission or ventilator support at screening or at randomization. suspected bacterial, fungal, viral, or other infection (besides covid-19). history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. history of hypertension should have hypertension adequately controlled (bp < 140/90 mmhg) with appropriate anti-hypertensive treatment. clinically significant cardiac conduction abnormalities, including qtc prolongation of > 450 milliseconds family history of long qt syndrome. heart failure class 3, or 4, as defined by the new york heart association (nyha). history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. patients with implanted defibrillators or permanent pacemakers. poorly controlled diabetes mellitus with an hba1c > 7.5 %. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) < 45 ml/min/1.73m2. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. known hepatitis b or c infection. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. alanine transaminase (alt) or aspartate transaminase (ast) >3.0 x uln. total bilirubin >1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. known allergy or hypersensitivity to the imp (including excipients). study participant is pregnant or breastfeeding. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

patient's clinical condition is worsening rapidly. requiring icu admission or ventilator support at screening or at randomization. suspected bacterial, fungal, viral, or other infection (besides covid-19). history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. history of hypertension should have hypertension adequately controlled (bp < 140/90 mmhg) with appropriate anti-hypertensive treatment. clinically significant cardiac conduction abnormalities, including qtc prolongation of > 450 milliseconds family history of long qt syndrome. heart failure class 3, or 4, as defined by the new york heart association (nyha). history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. patients with implanted defibrillators or permanent pacemakers. poorly controlled diabetes mellitus with an hba1c > 7.5 %. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) < 45 ml/min/1.73m2. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. known hepatitis b or c infection. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. alanine transaminase (alt) or aspartate transaminase (ast) >3.0 x uln. total bilirubin >1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. known allergy or hypersensitivity to the imp (including excipients). study participant is pregnant or breastfeeding. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

March 18, 2021, 12:31 a.m. usa

1. patient's clinical condition is worsening rapidly. 2. requiring icu admission or ventilator support at screening or at randomization. 3. suspected bacterial, fungal, viral, or other infection (besides covid-19). 4. history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. 5. history of hypertension should have hypertension adequately controlled (bp < 140/90 mmhg) with appropriate anti-hypertensive treatment. 6. clinically significant cardiac conduction abnormalities, including qtc prolongation of > 450 milliseconds 7. family history of long qt syndrome. 8. heart failure class 3, or 4, as defined by the new york heart association (nyha). 9. history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. patients with implanted defibrillators or permanent pacemakers. 11. poorly controlled diabetes mellitus with an hba1c > 7.5 %. 12. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. 13. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) < 45 ml/min/1.73m2. 14. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. 15. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. 17. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. known hepatitis b or c infection. 19. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. alanine transaminase (alt) or aspartate transaminase (ast) >3.0 x uln. 21. total bilirubin >1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). 22. taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9. 23. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. 24. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. 25. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. known allergy or hypersensitivity to the imp (including excipients). 27. study participant is pregnant or breastfeeding. 28. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

1. patient's clinical condition is worsening rapidly. 2. requiring icu admission or ventilator support at screening or at randomization. 3. suspected bacterial, fungal, viral, or other infection (besides covid-19). 4. history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. 5. history of hypertension should have hypertension adequately controlled (bp < 140/90 mmhg) with appropriate anti-hypertensive treatment. 6. clinically significant cardiac conduction abnormalities, including qtc prolongation of > 450 milliseconds 7. family history of long qt syndrome. 8. heart failure class 3, or 4, as defined by the new york heart association (nyha). 9. history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. patients with implanted defibrillators or permanent pacemakers. 11. poorly controlled diabetes mellitus with an hba1c > 7.5 %. 12. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. 13. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) < 45 ml/min/1.73m2. 14. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. 15. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. 17. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. known hepatitis b or c infection. 19. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. alanine transaminase (alt) or aspartate transaminase (ast) >3.0 x uln. 21. total bilirubin >1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). 22. taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9. 23. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. 24. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. 25. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. known allergy or hypersensitivity to the imp (including excipients). 27. study participant is pregnant or breastfeeding. 28. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

March 5, 2021, 12:31 a.m. usa

1. patient's clinical condition is worsening rapidly. 2. requiring icu admission or ventilator support at screening or at randomization. 3. suspected bacterial, fungal, viral, or other infection (besides covid-19). 4. history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. the medical monitor should be contacted by the investigator. 5. history of hypertension should have hypertension adequately controlled (bp < 140/90 mmhg) with appropriate anti-hypertensive treatment. 6. clinically significant cardiac conduction abnormalities, including qtc prolongation of > 450 milliseconds 7. family history of long qt syndrome. 8. heart failure class 3, or 4, as defined by the new york heart association (nyha). 9. history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. patients with implanted defibrillators or permanent pacemakers. 11. poorly controlled diabetes mellitus with an hba1c > 7.5 %. 12. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. 13. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) < 45 ml/min/1.73m2. 14. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. 15. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. 17. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. known hepatitis b or c infection. 19. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. alanine transaminase (alt) or aspartate transaminase (ast) >3.0 x uln. 21. total bilirubin >1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). 22. taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9. 23. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. 24. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. 25. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. known allergy or hypersensitivity to the imp (including excipients). 27. study participant is pregnant or breastfeeding. 28. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

1. patient's clinical condition is worsening rapidly. 2. requiring icu admission or ventilator support at screening or at randomization. 3. suspected bacterial, fungal, viral, or other infection (besides covid-19). 4. history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. the medical monitor should be contacted by the investigator. 5. history of hypertension should have hypertension adequately controlled (bp < 140/90 mmhg) with appropriate anti-hypertensive treatment. 6. clinically significant cardiac conduction abnormalities, including qtc prolongation of > 450 milliseconds 7. family history of long qt syndrome. 8. heart failure class 3, or 4, as defined by the new york heart association (nyha). 9. history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. patients with implanted defibrillators or permanent pacemakers. 11. poorly controlled diabetes mellitus with an hba1c > 7.5 %. 12. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. 13. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) < 45 ml/min/1.73m2. 14. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. 15. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. 17. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. known hepatitis b or c infection. 19. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. alanine transaminase (alt) or aspartate transaminase (ast) >3.0 x uln. 21. total bilirubin >1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). 22. taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9. 23. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. 24. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. 25. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. known allergy or hypersensitivity to the imp (including excipients). 27. study participant is pregnant or breastfeeding. 28. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

March 2, 2021, 12:31 a.m. usa

1. patient's clinical condition is worsening rapidly. 2. requiring icu admission or ventilator support at screening or at randomization. 3. suspected bacterial, fungal, viral, or other infection (besides covid-19). 4. history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. the medical monitor should be contacted by the investigator. 5. history of hypertension should have hypertension adequately controlled (bp < 140/90 mmhg) with appropriate anti-hypertensive treatment. 6. clinically significant cardiac conduction abnormalities, including qtc prolongation of > 450 milliseconds 7. family history of long qt syndrome. 8. heart failure class 3, or 4, as defined by the new york heart association (nyha). 9. history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. patients with implanted defibrillators or permanent pacemakers. 11. poorly controlled diabetes mellitus with an hba1c > 7.5 %. 12. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. 13. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) < 45 ml/min/1.73m2. 14. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. 15. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. 17. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. known hepatitis b or c infection. 19. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. alanine transaminase (alt) or aspartate transaminase (ast) >3.0 x uln. 21. total bilirubin >1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). 22. taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9 and listed as "prohibited" in section 10.5. 23. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. 24. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. 25. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. known allergy or hypersensitivity to the imp (including excipients). 27. study participant is pregnant or breastfeeding. 28. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.

1. patient's clinical condition is worsening rapidly. 2. requiring icu admission or ventilator support at screening or at randomization. 3. suspected bacterial, fungal, viral, or other infection (besides covid-19). 4. history of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. the medical monitor should be contacted by the investigator. 5. history of hypertension should have hypertension adequately controlled (bp < 140/90 mmhg) with appropriate anti-hypertensive treatment. 6. clinically significant cardiac conduction abnormalities, including qtc prolongation of > 450 milliseconds 7. family history of long qt syndrome. 8. heart failure class 3, or 4, as defined by the new york heart association (nyha). 9. history of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening. 10. patients with implanted defibrillators or permanent pacemakers. 11. poorly controlled diabetes mellitus with an hba1c > 7.5 %. 12. renal disease including glomerulonephritis, nephritic syndrome, fanconi syndrome, or renal tubular acidosis. 13. renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (egfr, ckd-epi) < 45 ml/min/1.73m2. 14. chronic obstructive pulmonary disease (copd) gold c, or d, or hospitalization for exacerbation of copd within 24 weeks prior to screening. 15. other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure. 16. asthma with a symptom control level of "uncontrolled", according to current gina guidelines. 17. currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (hiv) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation. 18. known hepatitis b or c infection. 19. any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient. 20. alanine transaminase (alt) or aspartate transaminase (ast) >3.0 x uln. 21. total bilirubin >1.0 x uln (≥1.5 x uln total bilirubin if known gilbert's syndrome). 22. taking concomitant medication metabolized by cyp2c8 and/ or cyp2c9 and listed as "prohibited" in section 10.5. 23. taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for covid-19. any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. inclusion needs to be approved by the investigator and medical monitor. 24. taking medication that may seriously affect the immune system, e.g., chemotherapy, unless considered and documented as standard of care (e.g., corticosteroids) to treat covid-19. 25. currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization. 26. known allergy or hypersensitivity to the imp (including excipients). 27. study participant is pregnant or breastfeeding. 28. patient has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 29. patient is an employee of the sponsor, or an employee of any third-party organization involved into the clinical trial, or an employee of the clinical trial site, or is dependent on the investigator.