covid-19 MedDRA version: 20.0 Level: LLT Classification code 10070267 Term: SARS virus test positive System Organ Class: 100000004848 MedDRA version: 21.1 Level: PT Classification code 10022519 Term: Intensive care System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Enoxaparine sodique
Product Name: enoxaparine sodique
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ENOXAPARIN SODIUM
CAS Number: 9041-08-1
Sponsors
CHU de Saint Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - To describe the relationship between enoxaparin concentration and thrombotic risk in resuscitation patients with CoV-2-SARS. - 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hemorrhage: - major hemorrhage as defined by the ISTH. - clinically "significant" but not major hemorrhage as defined by ISTH Venous thromboembolic events: - asymptomatic or symptomatic proximal deep vein thrombosis - asymptomatic or symptomatic pulmonary embolism Individual patient characteristics will be assessed by - Biological markers -Kidney function: creatininemia -Inflammation: CRP, inflammatory cytokines -Coagulation: fibrinogen, D-Dimers -Demographic characteristics Weight, age, sex, height, presence of a high thrombotic risk factor (history of venous thrombotics, active cancer, invasive mechanical ventilation) 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 | — |
Countries
France
Contacts
Public Contactproject manager
URCIP- CHU Saint Etienne
Outcome results
None listed