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

1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. <br/ >2.Subjects with Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute <br/ > <br/ >3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl) <30ml/min). <br/ >4.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 Molnupiravir. <br/ > <br/ >5.Pregnant or breast-feeding subjects will be excluded. <br/ >6.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. <br/ >8.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV), 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/ >9.Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10.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/ >11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ >12.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ >13.Participated in any other clinical trial or taken investigational drug within 1 month. <br/ >14.Any serious medical condition or evidence of multi organ failure or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the subjectâ??s safe participation in and completion of the study. <br/ >

1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. <br/ >2.Subjects with Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute <br/ > <br/ >3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl) <30ml/min). <br/ >4.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 Molnupiravir. <br/ > <br/ >5.Pregnant or breast-feeding subjects will be excluded. <br/ >6.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. <br/ >8.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV), 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/ >9.Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10.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/ >11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ >12.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ >13.Participated in any other clinical trial or taken investigational drug within 1 month. <br/ >14.Any serious medical condition or evidence of multi organ failure or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the subjectâ??s safe participation in and completion of the study. <br/ >

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

N/A

N/A

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

1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. <br/ >2.Subjects with Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute <br/ > <br/ >3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl) <30ml/min). <br/ >4.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 Molnupiravir. <br/ > <br/ >5.Pregnant or breast-feeding subjects will be excluded. <br/ >6.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. <br/ >8.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV), 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/ >9.Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10.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/ >11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ >12.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ >13.Participated in any other clinical trial or taken investigational drug within 1 month. <br/ >14.Any serious medical condition or evidence of multi organ failure or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the subjectâ??s safe participation in and completion of the study. <br/ >

1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. <br/ >2.Subjects with Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute <br/ > <br/ >3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl) <30ml/min). <br/ >4.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 Molnupiravir. <br/ > <br/ >5.Pregnant or breast-feeding subjects will be excluded. <br/ >6.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ >7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. <br/ >8.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV), 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/ >9.Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ >10.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/ >11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ >12.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ >13.Participated in any other clinical trial or taken investigational drug within 1 month. <br/ >14.Any serious medical condition or evidence of multi organ failure or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the subjectâ??s safe participation in and completion of the study. <br/ >