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

1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care. <br/ >2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ >3. Subjects with oxygen saturation (SPO2) â?¤90% or arterial oxygen <br/ >partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmHg. <br/ >4. Refractory nausea, vomiting, or chronic gastrointestinal disorders, <br/ >inability to swallow the study drug or having undergone extensive <br/ >bowel resection which may affect adequate absorption of Favipiravir. <br/ >5. Subjects with gout or hyperuricemia. <br/ >6. Pregnant or breast-feeding subjects. <br/ >7. Subject is using adrenocorticosteroids (except topical or inhaled <br/ >preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >8. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ >9. Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10. Subject has a psychiatric disease that is not well controlled where <br/ >controlled is defined as: stable on a regimen for more than one year. <br/ >11. Subject already treated with another COVID 19 therapy but has <br/ >relapsed with a positive diagnosis. <br/ >12. Anticipated transfer to another hospital which is not a study site <br/ >within 72 hours. <br/ >13. Participated in any other clinical trial or taken investigational drug <br/ >within 1 month. <br/ >

1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care. <br/ >2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ >3. Subjects with oxygen saturation (SPO2) â?¤90% or arterial oxygen <br/ >partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmHg. <br/ >4. Refractory nausea, vomiting, or chronic gastrointestinal disorders, <br/ >inability to swallow the study drug or having undergone extensive <br/ >bowel resection which may affect adequate absorption of Favipiravir. <br/ >5. Subjects with gout or hyperuricemia. <br/ >6. Pregnant or breast-feeding subjects. <br/ >7. Subject is using adrenocorticosteroids (except topical or inhaled <br/ >preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >8. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ >9. Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10. Subject has a psychiatric disease that is not well controlled where <br/ >controlled is defined as: stable on a regimen for more than one year. <br/ >11. Subject already treated with another COVID 19 therapy but has <br/ >relapsed with a positive diagnosis. <br/ >12. Anticipated transfer to another hospital which is not a study site <br/ >within 72 hours. <br/ >13. Participated in any other clinical trial or taken investigational drug <br/ >within 1 month. <br/ >

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

N/A

N/A

Oct. 26, 2020, 8:29 a.m. oms

1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care. <br/ >2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ >3. Subjects with oxygen saturation (SPO2) â?¤90% or arterial oxygen <br/ >partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmHg. <br/ >4. Refractory nausea, vomiting, or chronic gastrointestinal disorders, <br/ >inability to swallow the study drug or having undergone extensive <br/ >bowel resection which may affect adequate absorption of Favipiravir. <br/ >5. Subjects with gout or hyperuricemia. <br/ >6. Pregnant or breast-feeding subjects. <br/ >7. Subject is using adrenocorticosteroids (except topical or inhaled <br/ >preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >8. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ >9. Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10. Subject has a psychiatric disease that is not well controlled where <br/ >controlled is defined as: stable on a regimen for more than one year. <br/ >11. Subject already treated with another COVID 19 therapy but has <br/ >relapsed with a positive diagnosis. <br/ >12. Anticipated transfer to another hospital which is not a study site <br/ >within 72 hours. <br/ >13. Participated in any other clinical trial or taken investigational drug <br/ >within 1 month. <br/ >

1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care. <br/ >2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ >3. Subjects with oxygen saturation (SPO2) â?¤90% or arterial oxygen <br/ >partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmHg. <br/ >4. Refractory nausea, vomiting, or chronic gastrointestinal disorders, <br/ >inability to swallow the study drug or having undergone extensive <br/ >bowel resection which may affect adequate absorption of Favipiravir. <br/ >5. Subjects with gout or hyperuricemia. <br/ >6. Pregnant or breast-feeding subjects. <br/ >7. Subject is using adrenocorticosteroids (except topical or inhaled <br/ >preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >8. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ >9. Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10. Subject has a psychiatric disease that is not well controlled where <br/ >controlled is defined as: stable on a regimen for more than one year. <br/ >11. Subject already treated with another COVID 19 therapy but has <br/ >relapsed with a positive diagnosis. <br/ >12. Anticipated transfer to another hospital which is not a study site <br/ >within 72 hours. <br/ >13. Participated in any other clinical trial or taken investigational drug <br/ >within 1 month. <br/ >