Status:
UNKNOWN
Trial Evaluating Efficacy and Safety of Anticoagulation in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
COVID19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-Co...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
808 Patients enrolled
Trial Details
Trial ID
NCT04344756
Start Date
April 20 2020
End Date
September 30 2020
Last Update
April 15 2020
Active Locations (3)
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1
Réanimation hôpital Louis Mourier
Colombes, Hauts De Seine, France, 92701
2
réanimation hôpital Cochin
Paris, France, 75014
3
Médecine vasculaire, Hôpital Européen Georges Pompidou
Paris, France, 75015