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Completed

NCT Number: NCT04366960

Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients

The purpose of this study is to determine whether a higher dose of low molecular weight heparin (enoxaparin 40 mg b.i.d.) is superior than the standard prophylaxis dose (enoxaparin 40 mg o.d.) in reducing thromboembolic events in COVID-19 patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, 20162, Italy

About this study

Coronavirus disease-19 (COVID-19 ), which is caused by SARS-CoV-2 infection, are apparently at high risk of venous thromboembolism (VTE), as a consequence of activation of the hemostatic system which, in the most severe cases, can also be associated with the formation of microthrombi and clinically relevant disseminated intravascular coagulation. Concerns about the efficacy of thromboprophylaxis with standard doses of low-molecular-weight heparin (LMWH) has been raised. Therefore, LMWH at higher doses than those recommended for thromboprophylaxis is used in some hospitals, although no evidence exists yet of higher efficacy of high doses compared to standard prophylactic doses. This practice might as well increase the risk of major bleeding. The investigators designed a randomized trial comparing standard prophylactic dose of subcutaneous enoxaparin (40 mg o.d.) with higher dose (40 mg b.i.d) with the aim of testing whether high-dose thromboprophylaxis is more effective than standard dose in preventing VTE in COVID-19 patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All-comers patients aged >=18 years and admitted to hospital with laboratory-confirmed SARS-CoV-2 infection

Exclusion criteria

  • Patients admitted directly to an intensive care unit;
  • Estimated creatinine clearance <15 ml/min/1.73m2;
  • Patients needing anticoagulant for prior indication;
  • Participants involved in other clinical trials;
  • Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Treatment and study plan

Enoxaparin

Drug

Subcutaneous enoxaparin

Primary outcomes

  1. Incidence of venous thromboembolism detected by imaging

    Time frame: 30 days

    Deep vein thrombosis events diagnosed by serial compression ultrasonography and pulmonary embolism events diagnosed by computed tomography scan

Secondary outcomes

  1. In hospital major complications

    Time frame: 30 days

    death, venous thromboembolism, use of mechanical ventilation, stroke, acute myocardial infarction and admission to an intensive care

  2. Number of deep venous thrombosis events

    Time frame: 30 days

    Deep venous thrombosis events diagnosed by serial compression ultrasonography

  3. Sequential organ failure assessment

    Time frame: 30 days

    Maximum sequential organ failure assessment (SOFA) score comparison between the two groups.

    The SOFA score ranges from 0 to 24. Higher SOFA score is associated with a greater risk of death or prolonged intensive care unit stay.

  4. C-reactive protein

    Time frame: 30 days

    To compare C-reactive protein levels as % above the upper reference limit [URL]) among the two groups.

  5. Interleukin-6

    Time frame: 30 days

    To compare Interleukin-6 levels as % above the upper reference limit [URL]) among the two groups.

  6. D-dimer

    Time frame: 30 days

    To D-dimer compare levels as % above the upper reference limit [URL]) among the two groups.

  7. hs-troponin levels

    Time frame: 30 days

    To compare hs-troponin levels as % above the upper reference limit [URL]) among the two groups.

  8. Acute Respiratory Distress Syndrome

    Time frame: 30 days

    To compare the incidence of SARS-CoV-2-related Acute Respiratory Distress Syndrome (ARDS) between the two groups.

  9. Hospital stay

    Time frame: 30 days

    To compare length of hospital stay between the two groups.

  10. Right ventricular function

    Time frame: 30 days

    To compare measures of right ventricular function at trans-thoracic echocardiography or CT between admission and follow-up, whenever available

  11. Number of pulmonary embolism events

    Time frame: 30 days

    Pulmonary embolism events diagnosed by computed tomography scan

Sponsors and collaborators

Lead sponsor

Niguarda Hospital

Other

Registry information

Official study title

Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients: Comparison of 40 mg o.d. Versus 40 mg b.i.d. A Randomized Clinical Trial

Acronym: X-Covid 19

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2020
Registry last updated
Jun 8, 2021

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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