Created at Source Raw Value Validated value
March 31, 2021, 4:03 p.m. oms

(1) Patients who develop symptoms 8 or more days prior to enrollment(2) Patients with an SpO2 < 96 % (room air)(3) Patients who meet any of the following screening criteria:a) Alanine aminotransferase or aspartate aminotransferase levels five times higher than the upper limit of the reference range.b) Child Pugh class B or C.c) Serum creatinine levels two times higher than the upper limit of the reference range, and creatinine clearance is < 30 mL/min (Estimated Creatinine clearance using the Cockcroft Gault formula. However, actually measured values will be used if available).(4) Patients with poorly controlled diabetes (random blood glucose >= 200 mg/dL or HbA1c >= 7.0 % despite treatment).(5) Patients with serious complications who are deemed unsuitable for inclusion in the study based on the assessment by either the principal investigator or the sub-investigator.(6) Hemophilic patients or patients with a marked hemorrhagic tendency(7) Patients with severe diarrhea(8) Patients with a history of hypersensitivity to the ingredients of the investigational drug.(9) Female patients who are breastfeeding, pregnant, or of childbearing potential.(10) Patients who refused to adopt contraceptive methods during the study period from the initial administration of the investigational drug (male patients, and female patients of childbearing potential).(11) Patients who were receiving rifampicin within 2 weeks prior to obtaining informed consent.(12) Patients who participated in other clinical trials and received drugs within 12 weeks prior to obtaining informed consent.(13) Patients undergoing treatment for HIV infection(14) Patients who have been vaccinated against COVID-19, or wish to be vaccinated against COVID-19 while participating in the clinical trial(15) Other patients who are deemed inappropriate (miscellaneous reasons) for inclusion in the clinical trial based on the assessment by either the principal investigator or the sub investigator.

(1) Patients who develop symptoms 8 or more days prior to enrollment(2) Patients with an SpO2 < 96 % (room air)(3) Patients who meet any of the following screening criteria:a) Alanine aminotransferase or aspartate aminotransferase levels five times higher than the upper limit of the reference range.b) Child Pugh class B or C.c) Serum creatinine levels two times higher than the upper limit of the reference range, and creatinine clearance is < 30 mL/min (Estimated Creatinine clearance using the Cockcroft Gault formula. However, actually measured values will be used if available).(4) Patients with poorly controlled diabetes (random blood glucose >= 200 mg/dL or HbA1c >= 7.0 % despite treatment).(5) Patients with serious complications who are deemed unsuitable for inclusion in the study based on the assessment by either the principal investigator or the sub-investigator.(6) Hemophilic patients or patients with a marked hemorrhagic tendency(7) Patients with severe diarrhea(8) Patients with a history of hypersensitivity to the ingredients of the investigational drug.(9) Female patients who are breastfeeding, pregnant, or of childbearing potential.(10) Patients who refused to adopt contraceptive methods during the study period from the initial administration of the investigational drug (male patients, and female patients of childbearing potential).(11) Patients who were receiving rifampicin within 2 weeks prior to obtaining informed consent.(12) Patients who participated in other clinical trials and received drugs within 12 weeks prior to obtaining informed consent.(13) Patients undergoing treatment for HIV infection(14) Patients who have been vaccinated against COVID-19, or wish to be vaccinated against COVID-19 while participating in the clinical trial(15) Other patients who are deemed inappropriate (miscellaneous reasons) for inclusion in the clinical trial based on the assessment by either the principal investigator or the sub investigator.

Jan. 30, 2021, 12:45 a.m. oms

(1) Patients who develop symptoms 8 or more days prior to enrollment(2) Patients with an SpO2 < 96 % (room air)(3) Patients who meet any of the following screening criteria:a) Alanine aminotransferase or aspartate aminotransferase levels five times higher than the upper limit of the reference range.b) Child Pugh class B or C.c) Serum creatinine levels two times higher than the upper limit of the reference range, and creatinine clearance is < 30 mL/min (Estimated Creatinine clearance using the Cockcroft Gault formula. However, actually measured values will be used if available).(4) Patients with poorly controlled diabetes (random blood glucose >= 200 mg/dL or HbA1c >= 7.0 % despite treatment).(5) Patients with serious complications who are deemed unsuitable for inclusion in the study based on the assessment by either the principal investigator or the sub-investigator.(6) Hemophilic patients or patients with a marked hemorrhagic tendency(7) Patients with severe diarrhea(8) Patients with a history of hypersensitivity to the ingredients of the investigational drug.(9) Female patients who are breastfeeding, pregnant, or of childbearing potential.(10) Patients who refused to adopt contraceptive methods during the study period from the initial administration of the investigational drug (male patients, and female patients of childbearing potential).(11) Patients who were receiving rifampicin within 2 weeks prior to obtaining informed consent.(12) Patients who participated in other clinical trials and received drugs within 12 weeks prior to obtaining informed consent.(13) Patients undergoing treatment for HIV infection(14) Other patients who are deemed inappropriate (miscellaneous reasons) for inclusion in the clinical trial based on the assessment by either the principal investigator or the sub investigator.

(1) Patients who develop symptoms 8 or more days prior to enrollment(2) Patients with an SpO2 < 96 % (room air)(3) Patients who meet any of the following screening criteria:a) Alanine aminotransferase or aspartate aminotransferase levels five times higher than the upper limit of the reference range.b) Child Pugh class B or C.c) Serum creatinine levels two times higher than the upper limit of the reference range, and creatinine clearance is < 30 mL/min (Estimated Creatinine clearance using the Cockcroft Gault formula. However, actually measured values will be used if available).(4) Patients with poorly controlled diabetes (random blood glucose >= 200 mg/dL or HbA1c >= 7.0 % despite treatment).(5) Patients with serious complications who are deemed unsuitable for inclusion in the study based on the assessment by either the principal investigator or the sub-investigator.(6) Hemophilic patients or patients with a marked hemorrhagic tendency(7) Patients with severe diarrhea(8) Patients with a history of hypersensitivity to the ingredients of the investigational drug.(9) Female patients who are breastfeeding, pregnant, or of childbearing potential.(10) Patients who refused to adopt contraceptive methods during the study period from the initial administration of the investigational drug (male patients, and female patients of childbearing potential).(11) Patients who were receiving rifampicin within 2 weeks prior to obtaining informed consent.(12) Patients who participated in other clinical trials and received drugs within 12 weeks prior to obtaining informed consent.(13) Patients undergoing treatment for HIV infection(14) Other patients who are deemed inappropriate (miscellaneous reasons) for inclusion in the clinical trial based on the assessment by either the principal investigator or the sub investigator.

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

(1) Patients whose symptoms developed 8 or more days prior to enrollment(2) Patients whose SpO2 is <96% (room air)(3) Patients who meet any of the following screening test criteria:1) ALT or AST levels exceed five times the upper limit of the reference range.2) Child-Pugh class B or C.3) Serum creatinine levels exceed twice the upper limit of the reference range, and creatinine clearance levels are <30 mL/min. (Estimated creatinine clearance levels by the Cockcroft-Gault formula. However, actual measurement values will be used when available.)(4) Patients with poorly controlled diabetes (a casual blood glucose level of >=200 mg/dL or HbA1c of >=7.0% despite receiving diabetes treatment)(5) Patients with serious complications who are deemed unsuitable for inclusion in the clinical study based on the assessment by either the principal investigator or the sub-investigator(6) Hemophilic patients or patients with a marked hemorrhagic tendency(7) Patients with severe diarrhea symptoms(8) Patients with a previous history of hypersensitivity to the ingredients of the investigational drug(9) Female patients who are breastfeeding, pregnant, or female patients of childbearing potential(10) Patients who cannot use proper contraceptive methods during the study period from the initial administration of the investigational drug (male patients and female patients of childbearing potential)(11) Patients who were receiving rifampicin within 2 weeks prior to informed consent(12) Patients who participated in other clinical trials/studies and received drugs within 12 weeks prior to informed consent(13) Patients undergoing treatment for HIV infection (14) Other patients who for other reasons are deemed inappropriate for inclusion in the clinical trial based on the assessment by either the principal or sub-investigator

(1) Patients whose symptoms developed 8 or more days prior to enrollment(2) Patients whose SpO2 is <96% (room air)(3) Patients who meet any of the following screening test criteria:1) ALT or AST levels exceed five times the upper limit of the reference range.2) Child-Pugh class B or C.3) Serum creatinine levels exceed twice the upper limit of the reference range, and creatinine clearance levels are <30 mL/min. (Estimated creatinine clearance levels by the Cockcroft-Gault formula. However, actual measurement values will be used when available.)(4) Patients with poorly controlled diabetes (a casual blood glucose level of >=200 mg/dL or HbA1c of >=7.0% despite receiving diabetes treatment)(5) Patients with serious complications who are deemed unsuitable for inclusion in the clinical study based on the assessment by either the principal investigator or the sub-investigator(6) Hemophilic patients or patients with a marked hemorrhagic tendency(7) Patients with severe diarrhea symptoms(8) Patients with a previous history of hypersensitivity to the ingredients of the investigational drug(9) Female patients who are breastfeeding, pregnant, or female patients of childbearing potential(10) Patients who cannot use proper contraceptive methods during the study period from the initial administration of the investigational drug (male patients and female patients of childbearing potential)(11) Patients who were receiving rifampicin within 2 weeks prior to informed consent(12) Patients who participated in other clinical trials/studies and received drugs within 12 weeks prior to informed consent(13) Patients undergoing treatment for HIV infection (14) Other patients who for other reasons are deemed inappropriate for inclusion in the clinical trial based on the assessment by either the principal or sub-investigator