Created at Source Raw Value Validated value
Feb. 2, 2021, 5:16 p.m. usa

None

None

Oct. 26, 2020, 11:31 p.m. usa

- moribund or estimated life expectancy <1 month (e.g. terminal cancer, etc.) - pregnancy or breastfeeding - severe liver dysfunction (e.g. alt/ast > 5 times upper limit of normal) - stage 4 chronic kidney disease or requiring dialysis (except for ritonavir/lopinavir) - allergy or intolerances to any of the experimental substances -> exclusion for the respective treatment arm - anticipated discharge of hospital within 48 hours (for anti-viral treatment arms) - contraindications treatment arm 1: chloroquine/ hydroxychloroquine: concomitant amiodarone treatment, retinopathy, psoriasis, glucose-6-phosphate deficiency, severe cardiomyopathy and known, clinically relevant arrhythmias, porphyria cutanea tarda - clinically relevant qtc prolongation during screening - contraindications treatment arm 2: severe hepatic impairment, cyp3a4/5 metabolized drugs as deemed relevant by treating physicians, hiv positive - contraindications treatment arm 3: iga deficiency - sub-study a contraindications: active bleeding or bleeding diathesis, lesion or condition considered as major risk factor for bleeding, recent brain or spinal injury, recent brain or spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities. - sub-study a: ongoing therapeutic anticoagulation, which will continue, according to clinical practice - sub-study b contraindications chronic heart failure, allergies, hypersensitivities and intolerances, severe hepatic impairment and/or cholestasis, concomitant therapy with aliskiren-containing medications (for patients with diabetes mellitus or a gfr<60ml/min/1.73m2), known significant bilateral renal artery stenosis or renal artery stenosis of a solitary kidney - sub-study b: control group 1: with or without ras blockers, control group 2: healthy volunteers: concomitant medication with ras-blockers - sub-study c: contraindications clazakizumab arm: history of gastrointestinal perforation, diverticulitis, or inflammatory bowel disease, treatment with an il-6 or il-6r blocking drug (e.g. tocilizumab, sarilumab, siltuximab) <30 days before study inclusion.

- moribund or estimated life expectancy <1 month (e.g. terminal cancer, etc.) - pregnancy or breastfeeding - severe liver dysfunction (e.g. alt/ast > 5 times upper limit of normal) - stage 4 chronic kidney disease or requiring dialysis (except for ritonavir/lopinavir) - allergy or intolerances to any of the experimental substances -> exclusion for the respective treatment arm - anticipated discharge of hospital within 48 hours (for anti-viral treatment arms) - contraindications treatment arm 1: chloroquine/ hydroxychloroquine: concomitant amiodarone treatment, retinopathy, psoriasis, glucose-6-phosphate deficiency, severe cardiomyopathy and known, clinically relevant arrhythmias, porphyria cutanea tarda - clinically relevant qtc prolongation during screening - contraindications treatment arm 2: severe hepatic impairment, cyp3a4/5 metabolized drugs as deemed relevant by treating physicians, hiv positive - contraindications treatment arm 3: iga deficiency - sub-study a contraindications: active bleeding or bleeding diathesis, lesion or condition considered as major risk factor for bleeding, recent brain or spinal injury, recent brain or spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities. - sub-study a: ongoing therapeutic anticoagulation, which will continue, according to clinical practice - sub-study b contraindications chronic heart failure, allergies, hypersensitivities and intolerances, severe hepatic impairment and/or cholestasis, concomitant therapy with aliskiren-containing medications (for patients with diabetes mellitus or a gfr<60ml/min/1.73m2), known significant bilateral renal artery stenosis or renal artery stenosis of a solitary kidney - sub-study b: control group 1: with or without ras blockers, control group 2: healthy volunteers: concomitant medication with ras-blockers - sub-study c: contraindications clazakizumab arm: history of gastrointestinal perforation, diverticulitis, or inflammatory bowel disease, treatment with an il-6 or il-6r blocking drug (e.g. tocilizumab, sarilumab, siltuximab) <30 days before study inclusion.