Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
NCT Number: NCT04366960
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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Notify Me18 year and older
All sexes
Interventional
Phase 3
Milan, 20162, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous enoxaparin
Time frame: 30 days
Deep vein thrombosis events diagnosed by serial compression ultrasonography and pulmonary embolism events diagnosed by computed tomography scan
Time frame: 30 days
death, venous thromboembolism, use of mechanical ventilation, stroke, acute myocardial infarction and admission to an intensive care
Time frame: 30 days
Deep venous thrombosis events diagnosed by serial compression ultrasonography
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.
Time frame: 30 days
To compare C-reactive protein levels as % above the upper reference limit [URL]) among the two groups.
Time frame: 30 days
To compare Interleukin-6 levels as % above the upper reference limit [URL]) among the two groups.
Time frame: 30 days
To D-dimer compare levels as % above the upper reference limit [URL]) among the two groups.
Time frame: 30 days
To compare hs-troponin levels as % above the upper reference limit [URL]) among the two groups.
Time frame: 30 days
To compare the incidence of SARS-CoV-2-related Acute Respiratory Distress Syndrome (ARDS) between the two groups.
Time frame: 30 days
To compare length of hospital stay between the two groups.
Time frame: 30 days
To compare measures of right ventricular function at trans-thoracic echocardiography or CT between admission and follow-up, whenever available
Time frame: 30 days
Pulmonary embolism events diagnosed by computed tomography scan
Niguarda Hospital
Other
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
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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