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

1. Subject with history of hypersensitivity to Aviptadil or to any of the excipient. <br/ >2. Subjects on Mechanical ventilation for more than 7 days. <br/ >3. Transplant subjects currently immunosuppressed, <br/ >4. Subjects with Chemotherapy-induced neutropenia <br/ >(granulocyte count <1000/mm3), <br/ >5. Subjects with Cardiogenic shock, congestive heart failure â?? NYHA Class 3 or 4, <br/ >6. Subjects with Recent myocardial infarction â?? within last 6 months and troponin > 0.5. <br/ >7. Subjects with anuria (urine output < 50 ml/d) or other signs of multi-organ failure, <br/ >8. Irreversible condition (other than COVID-19) with projected fatal course. <br/ >9. Requirement of Extracorporeal membrane oxygenation (ECMO) <br/ >10. Severe liver disease with portal hypertension, <br/ >11. Recent stroke or head trauma within last 12 months <br/ >12. Increased intracranial pressure, or other serious neurologic disorder, <br/ >13. Liquid Diarrhea more than 3x/day, defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation. <br/ >14. Hypotension (i.e. Mean Arterial Pressure <65mmHg) that cannot be managed with pressors <br/ >15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. <br/ >16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. <br/ >17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C. <br/ >18. Suspected inability or unwillingness to comply with the study procedures. <br/ >19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientâ??s safety and efficacy of the drug. <br/ >20. Participation in any clinical study during last three months.

1. Subject with history of hypersensitivity to Aviptadil or to any of the excipient. <br/ >2. Subjects on Mechanical ventilation for more than 7 days. <br/ >3. Transplant subjects currently immunosuppressed, <br/ >4. Subjects with Chemotherapy-induced neutropenia <br/ >(granulocyte count <1000/mm3), <br/ >5. Subjects with Cardiogenic shock, congestive heart failure â?? NYHA Class 3 or 4, <br/ >6. Subjects with Recent myocardial infarction â?? within last 6 months and troponin > 0.5. <br/ >7. Subjects with anuria (urine output < 50 ml/d) or other signs of multi-organ failure, <br/ >8. Irreversible condition (other than COVID-19) with projected fatal course. <br/ >9. Requirement of Extracorporeal membrane oxygenation (ECMO) <br/ >10. Severe liver disease with portal hypertension, <br/ >11. Recent stroke or head trauma within last 12 months <br/ >12. Increased intracranial pressure, or other serious neurologic disorder, <br/ >13. Liquid Diarrhea more than 3x/day, defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation. <br/ >14. Hypotension (i.e. Mean Arterial Pressure <65mmHg) that cannot be managed with pressors <br/ >15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. <br/ >16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. <br/ >17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C. <br/ >18. Suspected inability or unwillingness to comply with the study procedures. <br/ >19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientâ??s safety and efficacy of the drug. <br/ >20. Participation in any clinical study during last three months.

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

N/A

N/A

Sept. 8, 2021, 1:30 a.m. oms

1. Subject with history of hypersensitivity to Aviptadil or to any of the excipient. <br/ >2. Subjects on Mechanical ventilation for more than 7 days. <br/ >3. Transplant subjects currently immunosuppressed, <br/ >4. Subjects with Chemotherapy-induced neutropenia <br/ >(granulocyte count <1000/mm3), <br/ >5. Subjects with Cardiogenic shock, congestive heart failure â?? NYHA Class 3 or 4, <br/ >6. Subjects with Recent myocardial infarction â?? within last 6 months and troponin > 0.5. <br/ >7. Subjects with anuria (urine output < 50 ml/d) or other signs of multi-organ failure, <br/ >8. Irreversible condition (other than COVID-19) with projected fatal course. <br/ >9. Requirement of Extracorporeal membrane oxygenation (ECMO) <br/ >10. Severe liver disease with portal hypertension, <br/ >11. Recent stroke or head trauma within last 12 months <br/ >12. Increased intracranial pressure, or other serious neurologic disorder, <br/ >13. Liquid Diarrhea more than 3x/day, defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation. <br/ >14. Hypotension (i.e. Mean Arterial Pressure <65mmHg) that cannot be managed with pressors <br/ >15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. <br/ >16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. <br/ >17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C. <br/ >18. Suspected inability or unwillingness to comply with the study procedures. <br/ >19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientâ??s safety and efficacy of the drug. <br/ >20. Participation in any clinical study during last three months.

1. Subject with history of hypersensitivity to Aviptadil or to any of the excipient. <br/ >2. Subjects on Mechanical ventilation for more than 7 days. <br/ >3. Transplant subjects currently immunosuppressed, <br/ >4. Subjects with Chemotherapy-induced neutropenia <br/ >(granulocyte count <1000/mm3), <br/ >5. Subjects with Cardiogenic shock, congestive heart failure â?? NYHA Class 3 or 4, <br/ >6. Subjects with Recent myocardial infarction â?? within last 6 months and troponin > 0.5. <br/ >7. Subjects with anuria (urine output < 50 ml/d) or other signs of multi-organ failure, <br/ >8. Irreversible condition (other than COVID-19) with projected fatal course. <br/ >9. Requirement of Extracorporeal membrane oxygenation (ECMO) <br/ >10. Severe liver disease with portal hypertension, <br/ >11. Recent stroke or head trauma within last 12 months <br/ >12. Increased intracranial pressure, or other serious neurologic disorder, <br/ >13. Liquid Diarrhea more than 3x/day, defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation. <br/ >14. Hypotension (i.e. Mean Arterial Pressure <65mmHg) that cannot be managed with pressors <br/ >15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. <br/ >16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. <br/ >17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C. <br/ >18. Suspected inability or unwillingness to comply with the study procedures. <br/ >19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientâ??s safety and efficacy of the drug. <br/ >20. Participation in any clinical study during last three months.