Weight-Adjusted vs Fixed Low Doses of Low Molecular Weight Heparin For Venous Thromboembolism Prevention in COVID-19

Summary

Worldwide observational studies indicate a significant prothrombogenic effect associated with SARS-CoV-2 infection with a high incidence of venous thromboembolism (VTE), notably life-threatening pulmonary embolism.

According to recommendations for acute medical illnesses, all COVID-19 hospitalized patients should be given VTE prophylaxis such as a low molecular weight heparin (LMWH). A standard prophylactic dose (eg. Enoxaparin 4000IU once daily) could be insufficient in obese patients and VTE has been reported in patients treated with a standard prophylactic dose.

In COVID-19 patients, guidelines from several international societies confirm the existence of an hypercoagulability and the importance of thromboprophylaxis but the "optimal dose is unknown" and comparative studies are needed.

In view of these elements, carrying out a trial comparing various therapeutic strategies for the prevention of VTE in hospitalized patients with COVID-19 constitutes a health emergency.

Thus, we hypothesize that an increased prophylactic dose of weight-adjusted LMWH would be greater than a lower prophylactic dose of LMWH to reduce the risk of life-threatening VTE in hospitalized patients. The benefit-risk balance of this increase dose will be carefully evaluated because of bleeding complications favored by possible renal / hepatic dysfunctions, drug interactions or invasive procedures in COVID-19 patients.

This multicenter randomized (1:1) open-label controlled trial will randomize hospitalized adults with COVID-19 infection to weight-adjusted prophylactic dose vs. lower prophylactic dose of LMWH.

Conditions

• COVID
• Thrombosis
• Pulmonary Embolism
• Deep Vein Thrombosis

Interventions

DRUG

Enoxaparin

For example (Enoxaparin): * 4000IU twice a day in patients \<50kg * 5000IU twice a day in patients 50-70kg * 6000IU twice a day in patients 70-100kg * 7000IU twice a day in patients above 100kg

DRUG

Enoxaparin

For example (Enoxaparin): From 4000IU once a day in patients admitted in medical ward to 4000IU twice a day in patients admitted in the ICU. In patients with severe renal insufficiency (GFR=15-30 mL/min/1.73m²), LMWH doses will be reduced by 50%.

Sponsors & Collaborators

• Ministry of Health, France

  collaborator OTHER_GOV

• Grand Est Region

  collaborator UNKNOWN

• University Hospital of Saint-Etienne

  collaborator OTHER

• Central Hospital, Nancy, France

  lead OTHER

Principal Investigators

• El Mehdi Siaghy · Research and Innovation Department, Nancy University Hospital

• Stéphane Zuily, MD, PhD · Nancy Academic Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-13

Primary Completion

2021-04-29

Completion

2021-09-14

Countries

• France

Study Locations