COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04516941

None

None

2020-08-18

Terminated

RCT

Randomized

Factorial

Open label

multi-center

Treatment

inclusion criteria: patients with laboratory confirmed sars-cov-2 infection (under rt pcr) who are managed at home or in another out-of-hospital setting.

hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including child-pugh c cirrhosis with portal hypertension. - lesion or condition, if considered to be a significant risk for major bleeding. this may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. - uncontrolled severe hypertension. - ongoing or planned treatment with parenteral or oral anticoagulants - unilateral or bilateral above knee lower extremity amputation. - inability to take oral medication or otherwise unable or unwilling to undergo/perform study-specified procedures - have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment - pregnancy or breast-feeding or any plan to become pregnant during the study. women (and men, for colchicine group only) with child-bearing potential not using adequate birth control method (note: as adequate method of birth control oral contraception is recommended. if oral contraception is not feasible, both partners should use adequate barrier birth control). - need for dual anti-platelet therapy consisting of aspirin and an oral p2y12 inhibitor - inflammatory bowel disease or chronic diarrhea or neuromuscular disease - creatinine clearance (crcl) <15 ml/min - anticipated use of hydroxychloroquine - participation in any other clinical trial - inability to understand the requirements of the study and to provide informed consent

4

Insel Gruppe AG, University Hospital Bern

18

100

Belgium;Italy;Switzerland

No restriction on type of patients

0: No restriction on type of patients

60

Colchicine vs no active treatment;Edoxaban vs. no active treatment

None

Phase 3

[{"arm_notes": "", "treatment_id": 444, "treatment_name": "Edoxaban", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1469, "treatment_name": "Colchicine+edoxaban", "treatment_type": "Metabolic agents+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]