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

Subjects will be excluded from the study for any of the following reasons: <br/ > <br/ >Subjects with known allergy or hypersensitivity to Niclosamide or any of its components. <br/ > <br/ >Patients who have previously had a disease severity score of 6 or 7 on the WHO 9-point ordinal scale. <br/ > <br/ >Evidence of severe or critical illness, defined by at least 1 of the following: <br/ > <br/ >Respiratory failure requiring at least 1 of the following: <br/ > <br/ >Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula <br/ > <br/ >Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure <br/ > <br/ >Shock (defined by systolic blood pressure (BP) <100 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), <br/ > <br/ >OR <br/ > <br/ >Multi-organ dysfunction/failure <br/ > <br/ >Subjects with Chronic liver disease (Child-Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ > <br/ >Renal dysfunction [Serum Creatinine > 2.5 times of ULN or calculated creatinine clearance < 30ml/min], Liver Dysfunction [Total Bilirubin > 3times ULN & AST/ALT >5times ULN]. <br/ > <br/ >Subjects with oxygen saturation (SpO2) â?¤90%. <br/ > <br/ >Respiration Rate â?¥30 breaths per minute at the time of enrolment. <br/ > <br/ >History of refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug, or having undergone extensive bowel resection which may affect adequate absorption of study medications. <br/ > <br/ >Inability to swallow tablets (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug). <br/ > <br/ >Patients who require IL-6 inhibitors for management of inflammation at the time of study entry. <br/ > <br/ >Female subjects who are pregnant or involved in breastfeeding. <br/ > <br/ >Subject was using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists, or interleukin receptor blockers) within one week prior to study entry. <br/ > <br/ >Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, 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/ > <br/ >Has a history of alcohol or drug abuse in the previous 6 months. <br/ > <br/ >Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year. <br/ > <br/ >Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ > <br/ >Hospital discharge is anticipated in â?¤24 hours. <br/ > <br/ >Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ > <br/ >Participated in any other clinical trial or taken an investigational drug within 1 month. <br/ >

Subjects will be excluded from the study for any of the following reasons: <br/ > <br/ >Subjects with known allergy or hypersensitivity to Niclosamide or any of its components. <br/ > <br/ >Patients who have previously had a disease severity score of 6 or 7 on the WHO 9-point ordinal scale. <br/ > <br/ >Evidence of severe or critical illness, defined by at least 1 of the following: <br/ > <br/ >Respiratory failure requiring at least 1 of the following: <br/ > <br/ >Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula <br/ > <br/ >Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure <br/ > <br/ >Shock (defined by systolic blood pressure (BP) <100 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), <br/ > <br/ >OR <br/ > <br/ >Multi-organ dysfunction/failure <br/ > <br/ >Subjects with Chronic liver disease (Child-Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ > <br/ >Renal dysfunction [Serum Creatinine > 2.5 times of ULN or calculated creatinine clearance < 30ml/min], Liver Dysfunction [Total Bilirubin > 3times ULN & AST/ALT >5times ULN]. <br/ > <br/ >Subjects with oxygen saturation (SpO2) â?¤90%. <br/ > <br/ >Respiration Rate â?¥30 breaths per minute at the time of enrolment. <br/ > <br/ >History of refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug, or having undergone extensive bowel resection which may affect adequate absorption of study medications. <br/ > <br/ >Inability to swallow tablets (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug). <br/ > <br/ >Patients who require IL-6 inhibitors for management of inflammation at the time of study entry. <br/ > <br/ >Female subjects who are pregnant or involved in breastfeeding. <br/ > <br/ >Subject was using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists, or interleukin receptor blockers) within one week prior to study entry. <br/ > <br/ >Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, 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/ > <br/ >Has a history of alcohol or drug abuse in the previous 6 months. <br/ > <br/ >Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year. <br/ > <br/ >Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ > <br/ >Hospital discharge is anticipated in â?¤24 hours. <br/ > <br/ >Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ > <br/ >Participated in any other clinical trial or taken an investigational drug within 1 month. <br/ >

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

N/A

N/A

Sept. 8, 2021, 1:30 a.m. oms

Subjects will be excluded from the study for any of the following reasons: <br/ > <br/ >Subjects with known allergy or hypersensitivity to Niclosamide or any of its components. <br/ > <br/ >Patients who have previously had a disease severity score of 6 or 7 on the WHO 9-point ordinal scale. <br/ > <br/ >Evidence of severe or critical illness, defined by at least 1 of the following: <br/ > <br/ >Respiratory failure requiring at least 1 of the following: <br/ > <br/ >Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula <br/ > <br/ >Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure <br/ > <br/ >Shock (defined by systolic blood pressure (BP) <100 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), <br/ > <br/ >OR <br/ > <br/ >Multi-organ dysfunction/failure <br/ > <br/ >Subjects with Chronic liver disease (Child-Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ > <br/ >Renal dysfunction [Serum Creatinine > 2.5 times of ULN or calculated creatinine clearance < 30ml/min], Liver Dysfunction [Total Bilirubin > 3times ULN & AST/ALT >5times ULN]. <br/ > <br/ >Subjects with oxygen saturation (SpO2) â?¤90%. <br/ > <br/ >Respiration Rate â?¥30 breaths per minute at the time of enrolment. <br/ > <br/ >History of refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug, or having undergone extensive bowel resection which may affect adequate absorption of study medications. <br/ > <br/ >Inability to swallow tablets (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug). <br/ > <br/ >Patients who require IL-6 inhibitors for management of inflammation at the time of study entry. <br/ > <br/ >Female subjects who are pregnant or involved in breastfeeding. <br/ > <br/ >Subject was using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists, or interleukin receptor blockers) within one week prior to study entry. <br/ > <br/ >Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, 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/ > <br/ >Has a history of alcohol or drug abuse in the previous 6 months. <br/ > <br/ >Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year. <br/ > <br/ >Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ > <br/ >Hospital discharge is anticipated in â?¤24 hours. <br/ > <br/ >Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ > <br/ >Participated in any other clinical trial or taken an investigational drug within 1 month. <br/ >

Subjects will be excluded from the study for any of the following reasons: <br/ > <br/ >Subjects with known allergy or hypersensitivity to Niclosamide or any of its components. <br/ > <br/ >Patients who have previously had a disease severity score of 6 or 7 on the WHO 9-point ordinal scale. <br/ > <br/ >Evidence of severe or critical illness, defined by at least 1 of the following: <br/ > <br/ >Respiratory failure requiring at least 1 of the following: <br/ > <br/ >Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula <br/ > <br/ >Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure <br/ > <br/ >Shock (defined by systolic blood pressure (BP) <100 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), <br/ > <br/ >OR <br/ > <br/ >Multi-organ dysfunction/failure <br/ > <br/ >Subjects with Chronic liver disease (Child-Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ > <br/ >Renal dysfunction [Serum Creatinine > 2.5 times of ULN or calculated creatinine clearance < 30ml/min], Liver Dysfunction [Total Bilirubin > 3times ULN & AST/ALT >5times ULN]. <br/ > <br/ >Subjects with oxygen saturation (SpO2) â?¤90%. <br/ > <br/ >Respiration Rate â?¥30 breaths per minute at the time of enrolment. <br/ > <br/ >History of refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug, or having undergone extensive bowel resection which may affect adequate absorption of study medications. <br/ > <br/ >Inability to swallow tablets (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug). <br/ > <br/ >Patients who require IL-6 inhibitors for management of inflammation at the time of study entry. <br/ > <br/ >Female subjects who are pregnant or involved in breastfeeding. <br/ > <br/ >Subject was using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists, or interleukin receptor blockers) within one week prior to study entry. <br/ > <br/ >Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, 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/ > <br/ >Has a history of alcohol or drug abuse in the previous 6 months. <br/ > <br/ >Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year. <br/ > <br/ >Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ > <br/ >Hospital discharge is anticipated in â?¤24 hours. <br/ > <br/ >Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ > <br/ >Participated in any other clinical trial or taken an investigational drug within 1 month. <br/ >