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Comparison of Two Doses of Enoxaparin for Thromboprophylaxis in Hospitalized COVID-19 Patients (X-Covid 19)

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ClinicalTrials.gov Identifier: NCT04366960
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Niguarda Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Enoxaparin Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label Multicentre Prospective Controlled Randomized Trial in patients with SARS-CoV-2 infection. Patients will be randomized 1:1 to 40 mg subcutaneous enoxaparin o.d. versus 40 mg enoxaparin b.i.d within 12 hours after hospitalization.
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 14, 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 40 mg subcutaneous enoxaparin o.d.
Effects of 40 mg subcutaneous enoxaparin o.d.
 Drug: Enoxaparin
Subcutaneous enoxaparin
Active Comparator: 40 mg subcutaneous enoxaparin b.i.d
Effects of 40 mg subcutaneous enoxaparin b.i.d
 Drug: Enoxaparin
Subcutaneous enoxaparin


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366960


Contacts
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Contact: Nuccia Morici, MD +396444 ext 2565 nuccia.morici@ospedaleniguarda.it

Locations
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Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda Recruiting
Milano, Italy, 20162
Contact: Nuccia Morici, MD    +026444 ext 2565    nuccia.morici@ospedaleniguarda.it   
Sponsors and Collaborators
Niguarda Hospital
More Information
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Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT04366960    
Other Study ID Numbers: 2020-001708-41
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Niguarda Hospital:
COVID19
Additional relevant MeSH terms:
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Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action