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

Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator. <br/ >Uncontrolled comorbid medical conditions <br/ >Patient is currently admitted to Intensive Care Unit (ICU) and has any one of the following symptoms. <br/ >Respiratory rate >30/min, breathlessness <br/ >SpO2 < 90% on room air <br/ >Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation. <br/ >If patient has any of the following conditions: human immunodeficiency virus (HIV), chemotherapy required within 6 weeks before randomization, a neutrophilic granulocyte absolute count <500/mm3, autologous or allogeneic hematopoietic stem cell transplant recipient. <br/ >If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. <br/ >If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. <br/ >Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. <br/ >Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion. <br/ >A baseline heart rate of < 60 beats per minute at rest <br/ >If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could <br/ >Limit gastrointestinal absorption based on previous medical records of the <br/ >patient

Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator. <br/ >Uncontrolled comorbid medical conditions <br/ >Patient is currently admitted to Intensive Care Unit (ICU) and has any one of the following symptoms. <br/ >Respiratory rate >30/min, breathlessness <br/ >SpO2 < 90% on room air <br/ >Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation. <br/ >If patient has any of the following conditions: human immunodeficiency virus (HIV), chemotherapy required within 6 weeks before randomization, a neutrophilic granulocyte absolute count <500/mm3, autologous or allogeneic hematopoietic stem cell transplant recipient. <br/ >If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. <br/ >If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. <br/ >Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. <br/ >Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion. <br/ >A baseline heart rate of < 60 beats per minute at rest <br/ >If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could <br/ >Limit gastrointestinal absorption based on previous medical records of the <br/ >patient

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

N/A

N/A

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

Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator. <br/ >Uncontrolled comorbid medical conditions <br/ >Patient is currently admitted to Intensive Care Unit (ICU) and has any one of the following symptoms. <br/ >Respiratory rate >30/min, breathlessness <br/ >SpO2 < 90% on room air <br/ >Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation. <br/ >If patient has any of the following conditions: human immunodeficiency virus (HIV), chemotherapy required within 6 weeks before randomization, a neutrophilic granulocyte absolute count <500/mm3, autologous or allogeneic hematopoietic stem cell transplant recipient. <br/ >If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. <br/ >If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. <br/ >Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. <br/ >Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion. <br/ >A baseline heart rate of < 60 beats per minute at rest <br/ >If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could <br/ >Limit gastrointestinal absorption based on previous medical records of the <br/ >patient

Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator. <br/ >Uncontrolled comorbid medical conditions <br/ >Patient is currently admitted to Intensive Care Unit (ICU) and has any one of the following symptoms. <br/ >Respiratory rate >30/min, breathlessness <br/ >SpO2 < 90% on room air <br/ >Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation. <br/ >If patient has any of the following conditions: human immunodeficiency virus (HIV), chemotherapy required within 6 weeks before randomization, a neutrophilic granulocyte absolute count <500/mm3, autologous or allogeneic hematopoietic stem cell transplant recipient. <br/ >If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. <br/ >If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. <br/ >Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. <br/ >Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion. <br/ >A baseline heart rate of < 60 beats per minute at rest <br/ >If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could <br/ >Limit gastrointestinal absorption based on previous medical records of the <br/ >patient