COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent Covid-19 or infection with SARS-CoV-2 or therapeutic agent to treat COVID-19. This protocol CORIMUNO19-COAG will evaluate the efficacy and safety of active anticoagulation using heparin: Tinzaparin (INNOHEP®) or unfractionated heparin (Calciparine®, Héparine Sodique Choay®) in COVID-19 patients hospitalized in conventional or intensive care units. It will use a phase 2 randomized open-label multicentre clinical trial, where patients will be randomly allocated to anticoagulation versus Standard of Care.
Drug: Tinzaparin or unfractionated heparin
Tinzaparin INNOHEP ® 175 IU/kg/24h for 14 days if creatinine clearance Cockcroft ≥ 20mL/min, Otherwise unfractionated heparin (Calciparine®, Héparine Sodique Choay®) subcutaneously or intravenous with an anti-Xa target between 0.5 and 0.7 IU/mL for 14 days
Inclusion Criteria:
1. 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
2. group 2 :
- Respiratory failure AND requiring mechanical ventilation
- WHO progression scale ≥ 6
- No do-not-resuscitate order (DNR order)
Exclusion Criteria:
- Patients with contraindications to anticoagulation
1. Congenital hemorrhagic disorders
2. Hypersensitivity to tinzaparin or UHF or to any of the excipients
3. Current or history of immune-mediated heparin-induced thrombocytopenia
4. 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.
5. Septic endocarditis
- Patients with need for anticoagulant therapy. For example: atrial fibrillation, venous
thromboembolism, mechanical valve, etc.
Réanimation hôpital Louis Mourier
Colombes, Hauts De Seine, France
réanimation hôpital Cochin
Paris, France
Médecine vasculaire, Hôpital Européen Georges Pompidou
Paris, France
Tristan Mirault
1 56 09 50 41 - 33
tristan.mirault@aphp.fr
Jean-Luc Diehl
jean-luc.diehl@aphp.fr