Sars-CoV2 Clinical Trial
— COV-ENOXOfficial title:
Evaluation of the Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention in COVID-19 Intensive Unit Care Patients.
Verified date | July 2020 |
Source | Centre Hospitalier Universitaire de Saint Etienne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with COVID-19 have special demographic characteristics including thromboembolic risk
factors .
The pharmacokinetics of enoxaparin administered subcutaneously in the intensive care unit
patient are not described.
Finally, given the lack of knowledge on the pharmacokinetic/pharmacodynamic properties of
enoxaparin in intensive care unit patients infected with SARS-CoV-2, we propose to conduct a
prospective multicenter cohort study to collect the biological data necessary for its study.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 10, 2020 |
Est. primary completion date | July 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Aged > 18 ans - SARS-CoV-2 infected intensive care unit patients - Diagnosis of SARS-CoV-2 respiratory infection was made with a nasopharyngeal swab or a deep respiratory specimen. - Patient receiving enoxaparin treatment as part of care or as part of a clinical trial for the prevention or treatment of thromboembolic venous disease. - Patient affiliated or entitled to a social security scheme Exclusion Criteria: - Creatinine clearance according to Cockcroft and Gault <30ml/min. - Hypersensitivity to enoxaparin sodium, heparin or its derivatives, including other low molecular weight heparins (LMWHs) - History of immune-mediated heparin-induced thrombocytopenia (HIT) in the last 100 days or in the presence of circulating antibodies - Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent hemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmologic surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysm or major intrarachidian or intracerebral vascular abnormalities. - Spinal, epidural or locoregional anaesthesia or anaesthesia when enoxaparin sodium is used for curative treatment within the previous 24 hours |
Country | Name | City | State |
---|---|---|---|
France | Groupement Hospitalier des portes de Province | Montélimar | |
France | Centre Hospitalier de Roanne | Roanne | |
France | CHU de Saint-Etienne | Saint-Étienne | |
France | Clinique Mutualiste | Saint-Étienne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Saint Etienne | CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure of anti-Xa activity | Measure of anti-Xa activity by chromogenic method. | Up to 1 month | |
Secondary | Analysis of hemorrhagic risk | Hemorrhagic risk is composite of : Major haemorrhage as defined by the International Society on Thrombosis and Haemostasis (ISTH) definition clinically significant haemorrhage |
Up to 1 month | |
Secondary | Venous thromboembolic events | Venous thromboembolic events is composite of: symptomatic or symptomatic proximal deep vein thrombosis asymptomatic or symptomatic pulmonary embolism |
Up to 1 month | |
Secondary | Analysis individual patient characteristics by the biomarker of Kidney function | Rate of creatinine. | Up to 1 month | |
Secondary | Analysis individual patient characteristics by the biomarker of inflammation | Biomarker of inflammation is composite of C-reactive protein (CRP) and inflammatory cytokines. | Up to 1 month | |
Secondary | Analysis individual patient characteristics by the biomarker of coagulation | Biomarker of coagulation is composite of fibrinogen and D-Dimers. | Up to 1 month | |
Secondary | Demographic characteristics | Analysis of weight, age, sex, height, presence of a high thrombotic risk factor (history of venous thrombotics, active cancer, invasive mechanical ventilation). | Up to 1 month |
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