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

Subjects meeting any of the following criteria must not be enrolled in the study: <br/ >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/ >Inability to intake or tolerate oral medications. <br/ >Severe liver disease: underlying liver cirrhosis 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/ >Oxygen saturation (SPO2) â?¤ 93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2)â?¤ 300 mmHg, <br/ >Requires ICU care for management of ongoing clinical status. <br/ >Known allergy or hypersensitivity to Favipiravir, <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 participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission.

Subjects meeting any of the following criteria must not be enrolled in the study: <br/ >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/ >Inability to intake or tolerate oral medications. <br/ >Severe liver disease: underlying liver cirrhosis 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/ >Oxygen saturation (SPO2) â?¤ 93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2)â?¤ 300 mmHg, <br/ >Requires ICU care for management of ongoing clinical status. <br/ >Known allergy or hypersensitivity to Favipiravir, <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 participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission.

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

N/A

N/A

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

Subjects meeting any of the following criteria must not be enrolled in the study: <br/ >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/ >Inability to intake or tolerate oral medications. <br/ >Severe liver disease: underlying liver cirrhosis 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/ >Oxygen saturation (SPO2) â?¤ 93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2)â?¤ 300 mmHg, <br/ >Requires ICU care for management of ongoing clinical status. <br/ >Known allergy or hypersensitivity to Favipiravir, <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 participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission.

Subjects meeting any of the following criteria must not be enrolled in the study: <br/ >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/ >Inability to intake or tolerate oral medications. <br/ >Severe liver disease: underlying liver cirrhosis 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/ >Oxygen saturation (SPO2) â?¤ 93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2)â?¤ 300 mmHg, <br/ >Requires ICU care for management of ongoing clinical status. <br/ >Known allergy or hypersensitivity to Favipiravir, <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 participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ >Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission.