Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

contraindications/hypersensitivity to p histicola or any of the capsule excipients patients with chronic hypoxia or underlying significant chronic respiratory disease (such as copd, pulmonary fibrosis, or bronchiectasis). admission to icu at time of screening. mechanically ventilated, on cpap, or on non-invasive ventilation at the time of screening. patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of covid standard of care treatment. patient has a diagnosed primary immunodeficiency. patient has a diagnosis of hiv/aids patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal replacement therapy (i.e. estimated glomerular filtration rate (egfr) <30ml/min/1.73m2) patient has pre-existing known significant liver disease with alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 5.0 x upper limit of normal (uln) patient has pre-existing known significant gastrointestinal tract disease expected to affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive bariatric surgery that could interfere with gi delivery and transit time. gi signs or symptoms equivalent to ctcae v5.0, gastrointestinal disorders, grade 3 or 4 event. patient has pre-existing known substantially impaired cardiac function or pre-existing clinically significant cardiac diseases, including unstable angina or acute myocardial infarction ≤ 6 weeks prior to screening. currently participating in an interventional clinical trial (observational studies allowed). moribund at time of screening

contraindications/hypersensitivity to p histicola or any of the capsule excipients patients with chronic hypoxia or underlying significant chronic respiratory disease (such as copd, pulmonary fibrosis, or bronchiectasis). admission to icu at time of screening. mechanically ventilated, on cpap, or on non-invasive ventilation at the time of screening. patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of covid standard of care treatment. patient has a diagnosed primary immunodeficiency. patient has a diagnosis of hiv/aids patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal replacement therapy (i.e. estimated glomerular filtration rate (egfr) <30ml/min/1.73m2) patient has pre-existing known significant liver disease with alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 5.0 x upper limit of normal (uln) patient has pre-existing known significant gastrointestinal tract disease expected to affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive bariatric surgery that could interfere with gi delivery and transit time. gi signs or symptoms equivalent to ctcae v5.0, gastrointestinal disorders, grade 3 or 4 event. patient has pre-existing known substantially impaired cardiac function or pre-existing clinically significant cardiac diseases, including unstable angina or acute myocardial infarction ≤ 6 weeks prior to screening. currently participating in an interventional clinical trial (observational studies allowed). moribund at time of screening

Oct. 26, 2020, 11:31 p.m. usa

1. contraindications/hypersensitivity to p histicola or any of the capsule excipients 2. patients with chronic hypoxia or underlying significant chronic respiratory disease (such as copd, pulmonary fibrosis, or bronchiectasis). 3. admission to icu at time of screening. 4. mechanically ventilated, on cpap, or on non-invasive ventilation at the time of screening. 5. patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of covid standard of care treatment. 6. patient has a diagnosed primary immunodeficiency. 7. patient has a diagnosis of hiv/aids 8. patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal replacement therapy (i.e. estimated glomerular filtration rate (egfr) <30ml/min/1.73m2) 9. patient has pre-existing known significant liver disease with alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 5.0 x upper limit of normal (uln) 10. patient has pre-existing known significant gastrointestinal tract disease expected to affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive bariatric surgery that could interfere with gi delivery and transit time. 11. gi signs or symptoms equivalent to ctcae v5.0, gastrointestinal disorders, grade 3 or 4 event. 12. patient has pre-existing known substantially impaired cardiac function or pre-existing clinically significant cardiac diseases, including unstable angina or acute myocardial infarction ≤ 6 weeks prior to screening. 13. currently participating in an interventional clinical trial (observational studies allowed). 14. moribund at time of screening

1. contraindications/hypersensitivity to p histicola or any of the capsule excipients 2. patients with chronic hypoxia or underlying significant chronic respiratory disease (such as copd, pulmonary fibrosis, or bronchiectasis). 3. admission to icu at time of screening. 4. mechanically ventilated, on cpap, or on non-invasive ventilation at the time of screening. 5. patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are given as part of covid standard of care treatment. 6. patient has a diagnosed primary immunodeficiency. 7. patient has a diagnosis of hiv/aids 8. patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal replacement therapy (i.e. estimated glomerular filtration rate (egfr) <30ml/min/1.73m2) 9. patient has pre-existing known significant liver disease with alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 5.0 x upper limit of normal (uln) 10. patient has pre-existing known significant gastrointestinal tract disease expected to affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive bariatric surgery that could interfere with gi delivery and transit time. 11. gi signs or symptoms equivalent to ctcae v5.0, gastrointestinal disorders, grade 3 or 4 event. 12. patient has pre-existing known substantially impaired cardiac function or pre-existing clinically significant cardiac diseases, including unstable angina or acute myocardial infarction ≤ 6 weeks prior to screening. 13. currently participating in an interventional clinical trial (observational studies allowed). 14. moribund at time of screening