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

1 <br/ >Participant requiring invasive ventilation or having hemodynamic instability (MOHFW guideline) or multiple organ dysfunction/failure or evidence of bacterial superinfection (as defined by Procalcitonin level greater than or equal to 0.5 μg/L or other applicable diagnostic parameters as per standard medical care) as per the independent clinical judgment of the Investigator at screening and /or baseline. <br/ >2 <br/ >Documented medical history of known allergies, hypersensitivity, or intolerance to intravenous immunoglobulin or other injectable form of IgG or blood products. <br/ >3 <br/ >Documented medical history of known IgA deficiency. <br/ >4 <br/ >Participants with a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction. <br/ >5 <br/ >Participants who have received any blood products within 30 days prior to randomization. <br/ >6 <br/ >Participant with more than 5 days of COVID-19 specific hospitalization prior to the first administration of treatment at baseline. <br/ >7 <br/ >Participants who have more than 10 days between the onset of symptoms and the day of first administration of treatment at baseline. <br/ >8 <br/ >Pregnant or breastfeeding female participants. <br/ >9 <br/ >Currently receiving renal replacement therapy/dialysis OR Creatinine clearance less than 50 mL/min using the Cockcroft-Gault formula. <br/ >10 <br/ >Documented medical history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening. <br/ >11 <br/ >Documented medical history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening. <br/ >12 <br/ >Currently receiving or has received in the last 14 days, experimental immune modulators, and/or monoclonal antibody therapies <br/ >13 <br/ >Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline <br/ >14 <br/ >Participants who have received organ transplantation or major surgery in the past 6 months. <br/ >15 <br/ >Participants whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal. <br/ >16 <br/ >Co-morbid systemic illnesses (uncontrolled diabetes, uncontrolled hypertension, cardiac disease, chronic lung disease, chronic kidney disease, immune-suppression and cancer or other severe concurrent disease) which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed treatment. <br/ >17 <br/ >Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry and have received an investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent. <br/ >18 <br/ >Participation in any other clinical trial of an experimental treatment for COVID-19. <br/ >19 <br/ >Any other clinical/social/ psychiatric condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the prot

1 <br/ >Participant requiring invasive ventilation or having hemodynamic instability (MOHFW guideline) or multiple organ dysfunction/failure or evidence of bacterial superinfection (as defined by Procalcitonin level greater than or equal to 0.5 μg/L or other applicable diagnostic parameters as per standard medical care) as per the independent clinical judgment of the Investigator at screening and /or baseline. <br/ >2 <br/ >Documented medical history of known allergies, hypersensitivity, or intolerance to intravenous immunoglobulin or other injectable form of IgG or blood products. <br/ >3 <br/ >Documented medical history of known IgA deficiency. <br/ >4 <br/ >Participants with a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction. <br/ >5 <br/ >Participants who have received any blood products within 30 days prior to randomization. <br/ >6 <br/ >Participant with more than 5 days of COVID-19 specific hospitalization prior to the first administration of treatment at baseline. <br/ >7 <br/ >Participants who have more than 10 days between the onset of symptoms and the day of first administration of treatment at baseline. <br/ >8 <br/ >Pregnant or breastfeeding female participants. <br/ >9 <br/ >Currently receiving renal replacement therapy/dialysis OR Creatinine clearance less than 50 mL/min using the Cockcroft-Gault formula. <br/ >10 <br/ >Documented medical history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening. <br/ >11 <br/ >Documented medical history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening. <br/ >12 <br/ >Currently receiving or has received in the last 14 days, experimental immune modulators, and/or monoclonal antibody therapies <br/ >13 <br/ >Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline <br/ >14 <br/ >Participants who have received organ transplantation or major surgery in the past 6 months. <br/ >15 <br/ >Participants whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal. <br/ >16 <br/ >Co-morbid systemic illnesses (uncontrolled diabetes, uncontrolled hypertension, cardiac disease, chronic lung disease, chronic kidney disease, immune-suppression and cancer or other severe concurrent disease) which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed treatment. <br/ >17 <br/ >Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry and have received an investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent. <br/ >18 <br/ >Participation in any other clinical trial of an experimental treatment for COVID-19. <br/ >19 <br/ >Any other clinical/social/ psychiatric condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the prot

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

N/A

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Nov. 6, 2020, 11:45 p.m. oms

1 <br/ >Participant requiring invasive ventilation or having hemodynamic instability (MOHFW guideline) or multiple organ dysfunction/failure or evidence of bacterial superinfection (as defined by Procalcitonin level greater than or equal to 0.5 μg/L or other applicable diagnostic parameters as per standard medical care) as per the independent clinical judgment of the Investigator at screening and /or baseline. <br/ >2 <br/ >Documented medical history of known allergies, hypersensitivity, or intolerance to intravenous immunoglobulin or other injectable form of IgG or blood products. <br/ >3 <br/ >Documented medical history of known IgA deficiency. <br/ >4 <br/ >Participants with a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction. <br/ >5 <br/ >Participants who have received any blood products within 30 days prior to randomization. <br/ >6 <br/ >Participant with more than 5 days of COVID-19 specific hospitalization prior to the first administration of treatment at baseline. <br/ >7 <br/ >Participants who have more than 10 days between the onset of symptoms and the day of first administration of treatment at baseline. <br/ >8 <br/ >Pregnant or breastfeeding female participants. <br/ >9 <br/ >Currently receiving renal replacement therapy/dialysis OR Creatinine clearance less than 50 mL/min using the Cockcroft-Gault formula. <br/ >10 <br/ >Documented medical history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening. <br/ >11 <br/ >Documented medical history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening. <br/ >12 <br/ >Currently receiving or has received in the last 14 days, experimental immune modulators, and/or monoclonal antibody therapies <br/ >13 <br/ >Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline <br/ >14 <br/ >Participants who have received organ transplantation or major surgery in the past 6 months. <br/ >15 <br/ >Participants whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal. <br/ >16 <br/ >Co-morbid systemic illnesses (uncontrolled diabetes, uncontrolled hypertension, cardiac disease, chronic lung disease, chronic kidney disease, immune-suppression and cancer or other severe concurrent disease) which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed treatment. <br/ >17 <br/ >Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry and have received an investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent. <br/ >18 <br/ >Participation in any other clinical trial of an experimental treatment for COVID-19. <br/ >19 <br/ >Any other clinical/social/ psychiatric condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the prot

1 <br/ >Participant requiring invasive ventilation or having hemodynamic instability (MOHFW guideline) or multiple organ dysfunction/failure or evidence of bacterial superinfection (as defined by Procalcitonin level greater than or equal to 0.5 μg/L or other applicable diagnostic parameters as per standard medical care) as per the independent clinical judgment of the Investigator at screening and /or baseline. <br/ >2 <br/ >Documented medical history of known allergies, hypersensitivity, or intolerance to intravenous immunoglobulin or other injectable form of IgG or blood products. <br/ >3 <br/ >Documented medical history of known IgA deficiency. <br/ >4 <br/ >Participants with a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction. <br/ >5 <br/ >Participants who have received any blood products within 30 days prior to randomization. <br/ >6 <br/ >Participant with more than 5 days of COVID-19 specific hospitalization prior to the first administration of treatment at baseline. <br/ >7 <br/ >Participants who have more than 10 days between the onset of symptoms and the day of first administration of treatment at baseline. <br/ >8 <br/ >Pregnant or breastfeeding female participants. <br/ >9 <br/ >Currently receiving renal replacement therapy/dialysis OR Creatinine clearance less than 50 mL/min using the Cockcroft-Gault formula. <br/ >10 <br/ >Documented medical history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening. <br/ >11 <br/ >Documented medical history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening. <br/ >12 <br/ >Currently receiving or has received in the last 14 days, experimental immune modulators, and/or monoclonal antibody therapies <br/ >13 <br/ >Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline <br/ >14 <br/ >Participants who have received organ transplantation or major surgery in the past 6 months. <br/ >15 <br/ >Participants whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal. <br/ >16 <br/ >Co-morbid systemic illnesses (uncontrolled diabetes, uncontrolled hypertension, cardiac disease, chronic lung disease, chronic kidney disease, immune-suppression and cancer or other severe concurrent disease) which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed treatment. <br/ >17 <br/ >Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry and have received an investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent. <br/ >18 <br/ >Participation in any other clinical trial of an experimental treatment for COVID-19. <br/ >19 <br/ >Any other clinical/social/ psychiatric condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the prot