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

1.Adults (â?¥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of theInvestigator, it is relevant to ongoing COVID 19). <br/ >2.Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. <br/ >3.A score of Grade 3 to 5 on the 9-point ordinal scale.In India, only patients with a score of Grade 4 or 5 will be enrolled. <br/ >4. a) Male patients: <br/ >â?¢A male patient must agree to use contraception as detailed in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. <br/ >b) Female patients: <br/ >â?¢A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: <br/ >i Not a woman of childbearing potential <br/ >OR <br/ >iiA woman of childbearing potential who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment. <br/ >5.Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). <br/ >6.Ability to provide informed consent signed by the study patient or legally authorised representative. <br/ > <br/ >

1.Adults (â?¥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of theInvestigator, it is relevant to ongoing COVID 19). <br/ >2.Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. <br/ >3.A score of Grade 3 to 5 on the 9-point ordinal scale.In India, only patients with a score of Grade 4 or 5 will be enrolled. <br/ >4. a) Male patients: <br/ >â?¢A male patient must agree to use contraception as detailed in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. <br/ >b) Female patients: <br/ >â?¢A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: <br/ >i Not a woman of childbearing potential <br/ >OR <br/ >iiA woman of childbearing potential who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment. <br/ >5.Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). <br/ >6.Ability to provide informed consent signed by the study patient or legally authorised representative. <br/ > <br/ >

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

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

1.Adults (â?¥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of theInvestigator, it is relevant to ongoing COVID 19). <br/ >2.Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. <br/ >3.A score of Grade 3 to 5 on the 9-point ordinal scale.In India, only patients with a score of Grade 4 or 5 will be enrolled. <br/ >4. a) Male patients: <br/ >â?¢A male patient must agree to use contraception as detailed in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. <br/ >b) Female patients: <br/ >â?¢A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: <br/ >i Not a woman of childbearing potential <br/ >OR <br/ >iiA woman of childbearing potential who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment. <br/ >5.Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). <br/ >6.Ability to provide informed consent signed by the study patient or legally authorised representative. <br/ > <br/ >

1.Adults (â?¥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of theInvestigator, it is relevant to ongoing COVID 19). <br/ >2.Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. <br/ >3.A score of Grade 3 to 5 on the 9-point ordinal scale.In India, only patients with a score of Grade 4 or 5 will be enrolled. <br/ >4. a) Male patients: <br/ >â?¢A male patient must agree to use contraception as detailed in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. <br/ >b) Female patients: <br/ >â?¢A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: <br/ >i Not a woman of childbearing potential <br/ >OR <br/ >iiA woman of childbearing potential who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment. <br/ >5.Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). <br/ >6.Ability to provide informed consent signed by the study patient or legally authorised representative. <br/ > <br/ >