COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04344756

Tristan Mirault

tristan.mirault@aphp.fr

2020-04-14

Not reported

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: group 1 : patients not requiring icu at admission with mild disease to severe pneumopathy according to the who criteria of severity of covid pneumopathy, and with symptom onset before 14 days, with need for oxygen but no non-invasive ventilation (niv) or high flow group 2 : respiratory failure and requiring mechanical ventilation who progression scale ≥ 6 no do-not-resuscitate order (dnr order)

patients with contraindications to anticoagulation congenital hemorrhagic disorders hypersensitivity to tinzaparin or uhf or to any of the excipients current or history of immune-mediated heparin-induced thrombocytopenia active major haemorrhage or conditions predisposing to major haemorrhage. major haemorrhage is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level of 20 g/l (1.24 mmol/l) or more, or c) leads to transfusion of 2 or more units of whole blood or red blood cells. septic endocarditis patients with need for anticoagulant therapy. for example: atrial fibrillation, venous thromboembolism, mechanical valve, etc.

2

Assistance Publique - Hôpitaux de Paris

18

None

France

Critical disease at enrollment

8: Critical disease at enrollment

808

ventilator free survival;Survival without ventilation (VNI or mechanical ventilation)

None

Phase 2

[{"arm_notes": "", "treatment_id": 1292, "treatment_name": "Tinzaparin", "treatment_type": "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"}]