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

Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ >Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >Severe respiratory distress and PaO2/FiO2 â?¤ 300 mmHg <br/ >Inability to intake or tolerate oral medications. <br/ >Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ >Gout/history of gout or hyperuricemia (above the ULN) <br/ >Prolonged QT, defined as QTcF â?¥450 milliseconds for men and as QTcF â?¥470 for women <br/ >Known severely reduced LV function (ejection fraction <30%) <br/ >Heart rate â?¥ 125 beats per minute <br/ >Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure). <br/ >Known allergy or hypersensitivity to favipiravir or umifenovir <br/ >Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers <br/ >Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing <br/ >Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis, <br/ >Asthma or chronic obstructive lung disease <br/ >Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). <br/ >Pregnant or lactating women, <br/ >Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival or requirement of palliative care.

Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ >Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >Severe respiratory distress and PaO2/FiO2 â?¤ 300 mmHg <br/ >Inability to intake or tolerate oral medications. <br/ >Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ >Gout/history of gout or hyperuricemia (above the ULN) <br/ >Prolonged QT, defined as QTcF â?¥450 milliseconds for men and as QTcF â?¥470 for women <br/ >Known severely reduced LV function (ejection fraction <30%) <br/ >Heart rate â?¥ 125 beats per minute <br/ >Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure). <br/ >Known allergy or hypersensitivity to favipiravir or umifenovir <br/ >Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers <br/ >Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing <br/ >Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis, <br/ >Asthma or chronic obstructive lung disease <br/ >Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). <br/ >Pregnant or lactating women, <br/ >Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival or requirement of palliative care.

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

N/A

N/A

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

Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ >Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >Severe respiratory distress and PaO2/FiO2 â?¤ 300 mmHg <br/ >Inability to intake or tolerate oral medications. <br/ >Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ >Gout/history of gout or hyperuricemia (above the ULN) <br/ >Prolonged QT, defined as QTcF â?¥450 milliseconds for men and as QTcF â?¥470 for women <br/ >Known severely reduced LV function (ejection fraction <30%) <br/ >Heart rate â?¥ 125 beats per minute <br/ >Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure). <br/ >Known allergy or hypersensitivity to favipiravir or umifenovir <br/ >Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers <br/ >Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing <br/ >Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis, <br/ >Asthma or chronic obstructive lung disease <br/ >Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). <br/ >Pregnant or lactating women, <br/ >Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival or requirement of palliative care.

Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ >Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ >Severe respiratory distress and PaO2/FiO2 â?¤ 300 mmHg <br/ >Inability to intake or tolerate oral medications. <br/ >Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ >Gout/history of gout or hyperuricemia (above the ULN) <br/ >Prolonged QT, defined as QTcF â?¥450 milliseconds for men and as QTcF â?¥470 for women <br/ >Known severely reduced LV function (ejection fraction <30%) <br/ >Heart rate â?¥ 125 beats per minute <br/ >Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure). <br/ >Known allergy or hypersensitivity to favipiravir or umifenovir <br/ >Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers <br/ >Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing <br/ >Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis, <br/ >Asthma or chronic obstructive lung disease <br/ >Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). <br/ >Pregnant or lactating women, <br/ >Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival or requirement of palliative care.