Created at Source Raw Value Validated value
June 25, 2024, noon usa

* previously or currently hospitalized or requiring hospitalization * respiratory distress with respiratory rate ≥ 25 breaths/min * heart rate ≥ 125 beats per minute * peripheral oxygen saturation ≤ 93% on room air at sea level * known allergies to any of the components used in the formulation of the interventions * severe renal impairment (egfr \<30 ml/min) * severe hepatic impairment (child-pugh class c) * co-administration with drugs highly dependent on cyp3a for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions * co-administration with potent cyp3a inducers * hemodynamic instability requiring use of pressors within 24 hours of randomization * suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) that could potentially lead to hospitalization in within 30 days * any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days * history of a positive sars-cov-2 test prior to the one serving as eligibility for this study * other investigational intervention for sars-cov-2 prophylaxis within 30 days before dosing * previous treatment with a sars-cov-2 specific monoclonal antibody * history of convalescent covid-19 plasma treatment * participation, within the last 30 days, in a clinical study involving an investigational intervention * pregnancy or breast feeding * investigator site personnel directly affiliated with this study * sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose * inability to participate to the study follow-up

* previously or currently hospitalized or requiring hospitalization * respiratory distress with respiratory rate ≥ 25 breaths/min * heart rate ≥ 125 beats per minute * peripheral oxygen saturation ≤ 93% on room air at sea level * known allergies to any of the components used in the formulation of the interventions * severe renal impairment (egfr \<30 ml/min) * severe hepatic impairment (child-pugh class c) * co-administration with drugs highly dependent on cyp3a for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions * co-administration with potent cyp3a inducers * hemodynamic instability requiring use of pressors within 24 hours of randomization * suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) that could potentially lead to hospitalization in within 30 days * any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days * history of a positive sars-cov-2 test prior to the one serving as eligibility for this study * other investigational intervention for sars-cov-2 prophylaxis within 30 days before dosing * previous treatment with a sars-cov-2 specific monoclonal antibody * history of convalescent covid-19 plasma treatment * participation, within the last 30 days, in a clinical study involving an investigational intervention * pregnancy or breast feeding * investigator site personnel directly affiliated with this study * sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose * inability to participate to the study follow-up

April 12, 2022, 11 p.m. usa

previously or currently hospitalized or requiring hospitalization respiratory distress with respiratory rate ≥ 25 breaths/min heart rate ≥ 125 beats per minute peripheral oxygen saturation ≤ 93% on room air at sea level known allergies to any of the components used in the formulation of the interventions severe renal impairment (egfr <30 ml/min) severe hepatic impairment (child-pugh class c) co-administration with drugs highly dependent on cyp3a for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions co-administration with potent cyp3a inducers hemodynamic instability requiring use of pressors within 24 hours of randomization suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) that could potentially lead to hospitalization in within 30 days any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days history of a positive sars-cov-2 test prior to the one serving as eligibility for this study other investigational intervention for sars-cov-2 prophylaxis within 30 days before dosing previous treatment with a sars-cov-2 specific monoclonal antibody history of convalescent covid-19 plasma treatment participation, within the last 30 days, in a clinical study involving an investigational intervention pregnancy or breast feeding investigator site personnel directly affiliated with this study sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose inability to participate to the study follow-up

previously or currently hospitalized or requiring hospitalization respiratory distress with respiratory rate ≥ 25 breaths/min heart rate ≥ 125 beats per minute peripheral oxygen saturation ≤ 93% on room air at sea level known allergies to any of the components used in the formulation of the interventions severe renal impairment (egfr <30 ml/min) severe hepatic impairment (child-pugh class c) co-administration with drugs highly dependent on cyp3a for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions co-administration with potent cyp3a inducers hemodynamic instability requiring use of pressors within 24 hours of randomization suspected or proven serious, active bacterial, fungal, viral, or other infection (besides covid-19) that could potentially lead to hospitalization in within 30 days any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days history of a positive sars-cov-2 test prior to the one serving as eligibility for this study other investigational intervention for sars-cov-2 prophylaxis within 30 days before dosing previous treatment with a sars-cov-2 specific monoclonal antibody history of convalescent covid-19 plasma treatment participation, within the last 30 days, in a clinical study involving an investigational intervention pregnancy or breast feeding investigator site personnel directly affiliated with this study sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose inability to participate to the study follow-up