Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

Patients may not be selected if any of the following criteria are <br/ >present <br/ >1. Any other cause of ARDS not attributable to SARS-CoV2. <br/ >2. Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure. <br/ >3. Presence of any active <br/ >malignancy. <br/ >4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug. <br/ >5. Patient with history of any stem cell transplant in the past. <br/ >6. Moderate to severe liver failure (Child â?? Pughâ??s score > 12). <br/ >7. Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home. <br/ >8. Patients for whom one week or longer has passed since the attachment of ventilator. <br/ >9. Patient with pulmonary transplant or having history of lung lobectomy. <br/ >10. Patient with clinically findings consistent with diffuse alveolar haemorrhage. <br/ >11. Patients with mean arterial (blood)pressure 12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation <br/ >(ECMO) at screening or currently receiving ECMO. <br/ >13. Patients who were resuscitated after cardio-respiratory arrest. <br/ >14. Patients with uncontrolled co-morbidities like hypertension,diabetes mellitus etc., as per investigator discretion <br/ >15. Patients who are under artificial dialysis at screening. <br/ >16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months. <br/ >17. Patients with a history of myocardial infarction within 6 months before screening. <br/ >18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented. <br/ >19. Pregnancy or breast feeding. <br/ >20. Patient with HIV infection. <br/ >21. Patient expected to have hypersensitivity for the study drug and/or excipients.

Patients may not be selected if any of the following criteria are <br/ >present <br/ >1. Any other cause of ARDS not attributable to SARS-CoV2. <br/ >2. Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure. <br/ >3. Presence of any active <br/ >malignancy. <br/ >4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug. <br/ >5. Patient with history of any stem cell transplant in the past. <br/ >6. Moderate to severe liver failure (Child â?? Pughâ??s score > 12). <br/ >7. Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home. <br/ >8. Patients for whom one week or longer has passed since the attachment of ventilator. <br/ >9. Patient with pulmonary transplant or having history of lung lobectomy. <br/ >10. Patient with clinically findings consistent with diffuse alveolar haemorrhage. <br/ >11. Patients with mean arterial (blood)pressure 12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation <br/ >(ECMO) at screening or currently receiving ECMO. <br/ >13. Patients who were resuscitated after cardio-respiratory arrest. <br/ >14. Patients with uncontrolled co-morbidities like hypertension,diabetes mellitus etc., as per investigator discretion <br/ >15. Patients who are under artificial dialysis at screening. <br/ >16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months. <br/ >17. Patients with a history of myocardial infarction within 6 months before screening. <br/ >18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented. <br/ >19. Pregnancy or breast feeding. <br/ >20. Patient with HIV infection. <br/ >21. Patient expected to have hypersensitivity for the study drug and/or excipients.

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Nov. 6, 2020, 11:45 p.m. oms

Patients may not be selected if any of the following criteria are <br/ >present <br/ >1. Any other cause of ARDS not attributable to SARS-CoV2. <br/ >2. Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure. <br/ >3. Presence of any active <br/ >malignancy. <br/ >4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug. <br/ >5. Patient with history of any stem cell transplant in the past. <br/ >6. Moderate to severe liver failure (Child â?? Pughâ??s score > 12). <br/ >7. Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home. <br/ >8. Patients for whom one week or longer has passed since the attachment of ventilator. <br/ >9. Patient with pulmonary transplant or having history of lung lobectomy. <br/ >10. Patient with clinically findings consistent with diffuse alveolar haemorrhage. <br/ >11. Patients with mean arterial (blood)pressure 12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation <br/ >(ECMO) at screening or currently receiving ECMO. <br/ >13. Patients who were resuscitated after cardio-respiratory arrest. <br/ >14. Patients with uncontrolled co-morbidities like hypertension,diabetes mellitus etc., as per investigator discretion <br/ >15. Patients who are under artificial dialysis at screening. <br/ >16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months. <br/ >17. Patients with a history of myocardial infarction within 6 months before screening. <br/ >18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented. <br/ >19. Pregnancy or breast feeding. <br/ >20. Patient with HIV infection. <br/ >21. Patient expected to have hypersensitivity for the study drug and/or excipients.

Patients may not be selected if any of the following criteria are <br/ >present <br/ >1. Any other cause of ARDS not attributable to SARS-CoV2. <br/ >2. Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure. <br/ >3. Presence of any active <br/ >malignancy. <br/ >4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug. <br/ >5. Patient with history of any stem cell transplant in the past. <br/ >6. Moderate to severe liver failure (Child â?? Pughâ??s score > 12). <br/ >7. Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home. <br/ >8. Patients for whom one week or longer has passed since the attachment of ventilator. <br/ >9. Patient with pulmonary transplant or having history of lung lobectomy. <br/ >10. Patient with clinically findings consistent with diffuse alveolar haemorrhage. <br/ >11. Patients with mean arterial (blood)pressure 12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation <br/ >(ECMO) at screening or currently receiving ECMO. <br/ >13. Patients who were resuscitated after cardio-respiratory arrest. <br/ >14. Patients with uncontrolled co-morbidities like hypertension,diabetes mellitus etc., as per investigator discretion <br/ >15. Patients who are under artificial dialysis at screening. <br/ >16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months. <br/ >17. Patients with a history of myocardial infarction within 6 months before screening. <br/ >18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented. <br/ >19. Pregnancy or breast feeding. <br/ >20. Patient with HIV infection. <br/ >21. Patient expected to have hypersensitivity for the study drug and/or excipients.