Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

1. Subject with known history of hypersensitivity or contraindication including anaphylaxis to Ursodeoxycholic acid to any of their components. <br/ > <br/ > 2. Subjects with any other cause of acute respiratory distress syndrome not attributable to SARS-CoV2 <br/ > <br/ > 3. Subjects with presence of any active malignancy <br/ > <br/ > 4. Subjects with potential chronic liver disease (Child Pugh A, B or C liver injury) <br/ > <br/ > 5. Subjects who received previous treatment with Ursodeoxycholic acid in last 30 days <br/ > <br/ > 6. Subjects with history of chronic use of corticosteroids and antiinflammatory agents more than 3 months at screening <br/ > <br/ > 7. Participation in other clinical trials and received drug treatment within 5 half-lives. <br/ > <br/ > 8. Subjects with Idiopathic Pulmonary Fibrosis diagnosis (based On American Thoracic Society (ATS), European Respiratory <br/ > Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) clinical practice guidelines 2018) <br/ > <br/ > 9. Subjects with history of significant pulmonary hypertension (PAH) defined by any of the following standards: <br/ > a. Clinical / echocardiographic evidence of previously significant right heart failure <br/ > b. Medical history including right heart catheter showing a cardiac index â?¤ 2 L/ min / m2 <br/ > c. Prostaglandin / Parenteral administration of prostacyclin in the treatment of PAH <br/ > <br/ > 10. Other clinically significant lung abnormalities considered by the investigator <br/ > <br/ > 11. Major extrapulmonary physiological limitations (such as chest wall deformity, large amount of pleural effusion) <br/ > <br/ > 12. Any of the following Cardiovascular diseases: <br/ > a. Severe hypertension within 6 months of screening visit, <br/ > uncontrollable after treatment (â?¥160 / 100 mmHg) <br/ > b. myocardial infarction within 6 months of screening visit <br/ > c. unstable angina within 6 months of screening visit <br/ > <br/ > 13. History of severe central nervous system (CNS) events <br/ > <br/ > 14. Other diseases that may interfere with the testing process or as judged by the investigator may interfere with the trial participation or may put the patient at risk when participating in <br/ > the trial <br/ > <br/ > 15. Women who are pregnant, breastfeeding, or planning pregnancy during this trial <br/ > <br/ > 16. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV). <br/ > <br/ > 17. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.

1. Subject with known history of hypersensitivity or contraindication including anaphylaxis to Ursodeoxycholic acid to any of their components. <br/ > <br/ > 2. Subjects with any other cause of acute respiratory distress syndrome not attributable to SARS-CoV2 <br/ > <br/ > 3. Subjects with presence of any active malignancy <br/ > <br/ > 4. Subjects with potential chronic liver disease (Child Pugh A, B or C liver injury) <br/ > <br/ > 5. Subjects who received previous treatment with Ursodeoxycholic acid in last 30 days <br/ > <br/ > 6. Subjects with history of chronic use of corticosteroids and antiinflammatory agents more than 3 months at screening <br/ > <br/ > 7. Participation in other clinical trials and received drug treatment within 5 half-lives. <br/ > <br/ > 8. Subjects with Idiopathic Pulmonary Fibrosis diagnosis (based On American Thoracic Society (ATS), European Respiratory <br/ > Society (ERS), Japanese Respiratory Society (JRS), and Latin American Thoracic Society (ALAT) clinical practice guidelines 2018) <br/ > <br/ > 9. Subjects with history of significant pulmonary hypertension (PAH) defined by any of the following standards: <br/ > a. Clinical / echocardiographic evidence of previously significant right heart failure <br/ > b. Medical history including right heart catheter showing a cardiac index â?¤ 2 L/ min / m2 <br/ > c. Prostaglandin / Parenteral administration of prostacyclin in the treatment of PAH <br/ > <br/ > 10. Other clinically significant lung abnormalities considered by the investigator <br/ > <br/ > 11. Major extrapulmonary physiological limitations (such as chest wall deformity, large amount of pleural effusion) <br/ > <br/ > 12. Any of the following Cardiovascular diseases: <br/ > a. Severe hypertension within 6 months of screening visit, <br/ > uncontrollable after treatment (â?¥160 / 100 mmHg) <br/ > b. myocardial infarction within 6 months of screening visit <br/ > c. unstable angina within 6 months of screening visit <br/ > <br/ > 13. History of severe central nervous system (CNS) events <br/ > <br/ > 14. Other diseases that may interfere with the testing process or as judged by the investigator may interfere with the trial participation or may put the patient at risk when participating in <br/ > the trial <br/ > <br/ > 15. Women who are pregnant, breastfeeding, or planning pregnancy during this trial <br/ > <br/ > 16. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV). <br/ > <br/ > 17. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.