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NCT Number: NCT04373707

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

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.

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Key information

Conditions

COVID Cardiovascular Diseases Deep Vein Thrombosis Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Amiens Academic Hospital, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient hospitalized for a probable/confirmed COVID-19 infection (confirmed by serology/polymerase chain reaction or by radiologic signs of COVID-19 pneumonia in the setting of clinical and laboratory abnormalities suggestive of a SARS-CoV-2 infection)
  • Signed informed consent
  • Patient affiliated to the Social Security

Exclusion criteria

  • Renal insufficiency with a GFR<15 mL/min/1.73m²
  • Acute kidney injury KDIGO3
  • Prophylactic dose of low molecular weight heparin for more than 3 days
  • Curative dose of low molecular weight heparin for more than 1 day
  • Recurrent catheter/hemodialysis access thromboses
  • ECMO required in the next 24h
  • Contraindication to low molecular weight heparin
  • High bleeding risk (e.g. uncontrolled severe systemic hypertension, recent major bleeding, disseminated intravascular coagulopathy, thrombocytopenia < 75G/L)
  • History of heparin-induced thrombocytopenia
  • Contraindication to blood-derived products
  • Impossibility to perform a doppler ultrasound of the lower limbs (e.g. above the knee amputation, severe burn injuries)
  • Expected death in the next 48h
  • Vulnerable subjects according to articles L. 1121-5, L. 1121-7 et L1121-8 of French Public Health Code

Treatment and study plan

Enoxaparin

Drug

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

Other names: Tinzaparin, Nadroparin, Dalteparin

Primary outcomes

  1. Venous thromboembolism

    Time frame: hospitalization stay (up to 28 days)

    Risk of deep vein thrombosis or pulmonary embolism or venous thromboembolism-related death

Secondary outcomes

  1. Major bleeding

    Time frame: hospitalization stay (up to 28 days)

    Risk of major bleeding defined by the ISTH

  2. Major Bleeding and Clinically Relevant Non-Major Bleeding

    Time frame: hospitalization stay (up to 28 days)

    Risk of Major Bleeding and Clinically Relevant Non-Major Bleeding Defined by the ISTH

  3. Net Clinical Benefit

    Time frame: hospitalization stay (up to 28 days) and 60 days

    Risk of Venous Thromboembolism and Major Bleeding

  4. Venous Thromboembolism at other sites

    Time frame: hospitalization stay (up to 28 days)

    Risk of venous thrombosis at other sites: e.g. superficial vein, catheters, hemodialysis access, ECMO, splanchnic, encephalic, upper limb

  5. Arterial Thrombosis

    Time frame: hospitalization stay (up to 28 days)

    Risk of arterial thrombosis at any sites

  6. All-Cause Mortality

    Time frame: hospitalization stay (up to 28 days) and 60 days

    Risk of all-cause mortality

  7. Factors associated with the risk of venous thromboembolism

    Time frame: hospitalization stay (up to 28 days)

    Identification of associations between the risk of venous thromboembolism and clinical (eg. past medical history of thrombosis, cardiovascular risk factors, treatments, severity of COVID-19) and laboratory variables (e.g. D-dimers, fibrinogen, CRP) collected in the eCRF

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Collaborators

  • Grand Est Region
  • Ministry of Health, France
  • University Hospital of Saint-Etienne

Registry information

Official study title

Effectiveness of Weight-adjusted Prophylactic Low Molecular Weight Heparin Doses Compared With Lower Fixed Prophylactic Doses to Prevent Venous Thromboembolism in COVID-2019. The Multicenter Randomized Controlled Open-label Trial COVI-DOSE

Acronym: COVI-DOSE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 4, 2020
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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