Created at Source Raw Value Validated value
Nov. 10, 2020, 12:30 a.m. eu

Patient's non-consent or inability to informed consent Pregnant or breastfeeding women Subjects pretreated with one of the active study drugs in the past 29 days Anticipated transfer within 72 hours to a non-study hospital Severe co-morbidity with life expectancy < 3 months according to investigators opinion AST or ALT > 5 times the upper limit of normal Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min) Contraindications to any of the active study drugs Subjects participating in a potentially confounding drug or device trial during the course of the study in the last 29 days Any reason why, in the opinion of the investigators, the patient should not participate

Patient's non-consent or inability to informed consent Pregnant or breastfeeding women Subjects pretreated with one of the active study drugs in the past 29 days Anticipated transfer within 72 hours to a non-study hospital Severe co-morbidity with life expectancy < 3 months according to investigators opinion AST or ALT > 5 times the upper limit of normal Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min) Contraindications to any of the active study drugs Subjects participating in a potentially confounding drug or device trial during the course of the study in the last 29 days Any reason why, in the opinion of the investigators, the patient should not participate

Oct. 26, 2020, 7:26 a.m. eu

Patient's non-consent or inability to informed consent Anticipated transfer within 72 hours to a non-study hospital Contraindications to any of the study drugs (see Appendix A5.3) Known intolerance to the available study drugs Further need of medications, which cannot be discontinued and which are contraindicated with lopinavir/ritonavir, i.e. drugs whose metabolism is highly dependent on the isoform CYP3A with narrow therapeutic range (e.g. amiodarone, colchicine) Subjects pretreated with remdesivir, interferon ß-1a, lopinavir/ritonavir in the past 29 days Subjects with body weight of < 50 kg Severe co-morbidity with life expectancy < 3 months according to investigators opinion ASAT or ALAT > 5 times the upper limit of normal Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min) History of severe depression or attempted suicide or current suicidal ideation HIV-infection, treated with high active antiretroviral therapy (HAART) Pregnant or breastfeeding women. Subjects participating in a potentially confounding drug or device trial during the course of the study in the last 29 days Any reason why, in the opinion of the investigators, the patient should not participate

Patient's non-consent or inability to informed consent Anticipated transfer within 72 hours to a non-study hospital Contraindications to any of the study drugs (see Appendix A5.3) Known intolerance to the available study drugs Further need of medications, which cannot be discontinued and which are contraindicated with lopinavir/ritonavir, i.e. drugs whose metabolism is highly dependent on the isoform CYP3A with narrow therapeutic range (e.g. amiodarone, colchicine) Subjects pretreated with remdesivir, interferon ß-1a, lopinavir/ritonavir in the past 29 days Subjects with body weight of < 50 kg Severe co-morbidity with life expectancy < 3 months according to investigators opinion ASAT or ALAT > 5 times the upper limit of normal Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min) History of severe depression or attempted suicide or current suicidal ideation HIV-infection, treated with high active antiretroviral therapy (HAART) Pregnant or breastfeeding women. Subjects participating in a potentially confounding drug or device trial during the course of the study in the last 29 days Any reason why, in the opinion of the investigators, the patient should not participate