Created at Source Raw Value Validated value
June 2, 2022, 8 a.m. oms

1) If one or more of the following severe findings were shown at the time of screening - Oxygen saturation (SpO2) less than 94% in indoor air conditions - Respiratory rate greater than 30 breaths per minute - PaO2/FiO2 < 300 mmHg - Lung infiltration >50% on chest imaging 2) Subjects who require oxygen therapy (Supplemental oxygen, Non-invasive ventilation, invasive ventilation, extracorporeal membrane oxygenation, etc.) or have serious conditions such as respiratory failure, shock, or multiple organ failure 3) Those who have hypersensitivity to the main ingredient (niclosamide) and components of the clinical investigational drug 4) Subjects with genetic problems such as lactose intolerance, galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption 5) Subjects with renal impairment (eGFR < 30 mL/min/1.73 m2) 6) Subjects with hepatic impairment (ALT or AST > 5 times the upper limit of normal organ) 7) Cirrhosis Subjects with a Child-Pugh score of B or C A B C Ascites None Easily controlled Poorly controlled Bilirubin < 2 mg/dL 2~3 mg/dL > 3 mg/dL Albumin > 3.5 g/dL 3.0~3.5 g/dL < 3.0 g/dL Encephalopathy None Mild Advanced Nutritional status Excellent Good Poor 8) Subjects with gastrointestinal diseases and surgeries that may affect drug absorption, distribution, metabolism, and excretion (except for simple appendicectomy or hernia surgery) 9) Those who have received drugs such as antiviral agents, neutralizing antibody therapy, plasma fraction therapy, and immune modulators (cytokine therapy, etc.) for the treatment of coronavirus infection-19 infection within 28 days of the screening test. However, after a sufficient withdrawal period of the drug has elapsed, it is possible to participate in the clinical trial. 10) If you have one or more of the following infectious diseases in the past or present - Viral diseases other than COVID-19 (HIV, HBV, HCV, etc.) that require administration of other antiviral drugs - Serious infections that require systemic anti-infective treatment other than COVID-19 infection within 30 days before administration of the investigational drug 11) Pregnant or lactating women 12) Women and men of childbearing potential who plan to become pregnant or do not intend to use the appropriate contraception* *hormonal contraception, intrauterine device, double blocking method (both male (condom) and female (contraceptive diaphragm, vaginal sponge or cervical cap) use), sterilization (vasectomy, tubal ligation, etc.) 13) Those who have participated in other clinical trials/medical device clinical trials within 28 days from the date of signing the consent form and have received/administered/treated clinical investigational drugs/medical devices 14) Those who have chronic underlying diseases that are unsuitable for participation in the clinical trial as judged by the investigator, and those who are judged inappropriate for the investigator to participate in this clinical trial for other reasons

1) If one or more of the following severe findings were shown at the time of screening - Oxygen saturation (SpO2) less than 94% in indoor air conditions - Respiratory rate greater than 30 breaths per minute - PaO2/FiO2 < 300 mmHg - Lung infiltration >50% on chest imaging 2) Subjects who require oxygen therapy (Supplemental oxygen, Non-invasive ventilation, invasive ventilation, extracorporeal membrane oxygenation, etc.) or have serious conditions such as respiratory failure, shock, or multiple organ failure 3) Those who have hypersensitivity to the main ingredient (niclosamide) and components of the clinical investigational drug 4) Subjects with genetic problems such as lactose intolerance, galactose intolerance, Lapp lactase deficiency, and glucose-galactose malabsorption 5) Subjects with renal impairment (eGFR < 30 mL/min/1.73 m2) 6) Subjects with hepatic impairment (ALT or AST > 5 times the upper limit of normal organ) 7) Cirrhosis Subjects with a Child-Pugh score of B or C A B C Ascites None Easily controlled Poorly controlled Bilirubin < 2 mg/dL 2~3 mg/dL > 3 mg/dL Albumin > 3.5 g/dL 3.0~3.5 g/dL < 3.0 g/dL Encephalopathy None Mild Advanced Nutritional status Excellent Good Poor 8) Subjects with gastrointestinal diseases and surgeries that may affect drug absorption, distribution, metabolism, and excretion (except for simple appendicectomy or hernia surgery) 9) Those who have received drugs such as antiviral agents, neutralizing antibody therapy, plasma fraction therapy, and immune modulators (cytokine therapy, etc.) for the treatment of coronavirus infection-19 infection within 28 days of the screening test. However, after a sufficient withdrawal period of the drug has elapsed, it is possible to participate in the clinical trial. 10) If you have one or more of the following infectious diseases in the past or present - Viral diseases other than COVID-19 (HIV, HBV, HCV, etc.) that require administration of other antiviral drugs - Serious infections that require systemic anti-infective treatment other than COVID-19 infection within 30 days before administration of the investigational drug 11) Pregnant or lactating women 12) Women and men of childbearing potential who plan to become pregnant or do not intend to use the appropriate contraception* *hormonal contraception, intrauterine device, double blocking method (both male (condom) and female (contraceptive diaphragm, vaginal sponge or cervical cap) use), sterilization (vasectomy, tubal ligation, etc.) 13) Those who have participated in other clinical trials/medical device clinical trials within 28 days from the date of signing the consent form and have received/administered/treated clinical investigational drugs/medical devices 14) Those who have chronic underlying diseases that are unsuitable for participation in the clinical trial as judged by the investigator, and those who are judged inappropriate for the investigator to participate in this clinical trial for other reasons