ow-molecular-weight heparin to prevent venous thromboembolism in COVID-19 patients : a randomized controlled trial of different doses

Phase 1

• Conditions: Prevention of thromboembolic events in hospitalised COVID-19 infected patients; MedDRA version: 20.0Level: HLGTClassification code 10014523Term: Embolism and thrombosisSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-001709-21-FR
• Lead Sponsor: CHRU de Nancy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-16
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

- Adult
- Having been given an informed consent to participate or consent from relatives in case of vital emergency (patients not able to give a consent)
-Hospitalization for a acute respiratory COVID-19 infection probable or confirmed
-SARS-Cov-2 infection diagnosed by biology (positive PCR for COVID-19 on a nasophayngeal swab or any other saple and/or serological method) or by a composite criterium associating lung injury on imaging and clinical / biological symptoms suggestive of COVID-19 (eg : dyspnea, cough, fever, biological inflammatory syndrome, lymphopenia, elevated liver enzymes).
- Health Insurance Coverage

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 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 320

Exclusion Criteria

-End-stage kidney disease (glomerular filtration rate < 15 mL/min/1.73m²)
-Acute kidney failure KDIGO 3
-Having received at least 3 doses prophylaxis of low molecular weight heparin before the inclusion
-Therapeutic-dose of anticoagulant treatment for more than 24 hours, whatever the route or the drug prescribed for an other indication such as atrial fibrillation, thomboembolic venous disease needing an prolonged treatment, prosthetic heart valves, ...
-Iterative catheter-related thrombosis or thrombosis of an extracorporeal membrane oxygenation
- ECMO to be implemented within 24 hours.
-All contraindication to treatment with low molecular weight heparin
-High hemorrhagic risk: resistant systolic (> 180 mmHg) or diastolic (> 110 mmHg) hypertension during more than 12 hours or needing an intravenous treatment, recent (< 7j) major bleeding or non-resolved bleeding, coagulopathy (INR>2N ou ACT>2N), thrombocytopenia < 75 G/L, heparin-induced thrombocytopenia, contraindication to blood-derived products
-Lower limb Venous Doppler ultrasound not feasible (bilateral transfemoral amputation, or severe burns)
- Death expected within 48 hours
- Persons referred in articles L.1121-5 to L.1121-8 and L.1122-2 of the Public Health Code:
oPregnant, parturient or breastfeeding woman;
oPerson deprived of liberty for judicial or administrative decision;
oPerson under psychiatric care;
oMinor person (non-emancipated);
oAdult person under legal protection (any form of public guardianship).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified