Evaluation of the concentration-effect relationship of enoxaparin for thromboembolic prevention in COVID-19 resuscitation patients. COV-ENOX study
- Conditions
- covid-19MedDRA version: 20.0Level: LLTClassification code 10070267Term: SARS virus test positiveSystem Organ Class: 100000004848MedDRA version: 21.1Level: PTClassification code 10022519Term: Intensive careSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-001823-15-FR
- Lead Sponsor
- CHU de Saint Etienne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
- Adult patients at least 18 years of age
- Patients hospitalized in the intensive care unit infected with SARS-CoV-
2, for whom a diagnosis of respiratory SARS-CoV-2 infection was made
by nasopharyngeal swab or deep respiratory sampling (patients on HDON or artificial ventilation)
- Patient receiving enoxaparin therapy 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
- 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 intrarachid or intracerebral vascular abnormalities.
- Spinal, epidural or locoregional anaesthesia or anaesthesia when enoxaparin sodium is used for curative treatment within the previous 24 hours
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the pharmacokinetics of enoxaparin in resuscitation patients infected with CoV-2-SARS.;Secondary Objective: - To describe the relationship between enoxaparin concentration and bleeding risk in resuscitation patients with CoV-2-SARS.<br><br>- To describe the relationship between enoxaparin concentration and thrombotic risk in resuscitation patients with CoV-2-SARS.<br><br>- To propose optimal enoxaparin administration regimens tailored to individual patient characteristics.;Primary end point(s): Measurement of the anti-Xa activity of enoxaparin by chromogenic method.;Timepoint(s) of evaluation of this end point: daily for 30 days or until the complete decrease of drug
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Hemorrhage:<br> - major hemorrhage as defined by the ISTH. <br> - clinically significant but not major hemorrhage as defined by ISTH <br><br>Venous thromboembolic events: <br> - asymptomatic or symptomatic proximal deep vein thrombosis<br> - asymptomatic or symptomatic pulmonary embolism <br><br>Individual patient characteristics will be assessed by<br> - Biological markers <br> -Kidney function: creatininemia<br> -Inflammation: CRP, inflammatory cytokines<br> -Coagulation: fibrinogen, D-Dimers<br> -Demographic characteristics Weight, age, sex, height, presence of a high thrombotic risk factor (history of venous thrombotics, active cancer, invasive mechanical ventilation)<br><br>Translated with www.DeepL.com/Translator (free version);Timepoint(s) of evaluation of this end point: daily for 30 days or until the complete decrease of drug