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

Covid19 Clinical Trial

— X-Covid 19  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366960
• Other study ID #: 2020-001708-41
• Status: Completed
• Phase: Phase 3
• Start date: May 14, 2020
• Est. completion date: May 25, 2021

Study information

• Verified date: June 2021
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: May 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Enoxaparin
Subcutaneous enoxaparin

Locations

Country	Name	City	State
Italy	Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of venous thromboembolism detected by imaging	Deep vein thrombosis events diagnosed by serial compression ultrasonography and pulmonary embolism events diagnosed by computed tomography scan	30 days
Secondary	In hospital major complications	death, venous thromboembolism, use of mechanical ventilation, stroke, acute myocardial infarction and admission to an intensive care	30 days
Secondary	Number of deep venous thrombosis events	Deep venous thrombosis events diagnosed by serial compression ultrasonography	30 days
Secondary	Sequential organ failure assessment	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.	30 days
Secondary	C-reactive protein	To compare C-reactive protein levels as % above the upper reference limit [URL]) among the two groups.	30 days
Secondary	Interleukin-6	To compare Interleukin-6 levels as % above the upper reference limit [URL]) among the two groups.	30 days
Secondary	D-dimer	To D-dimer compare levels as % above the upper reference limit [URL]) among the two groups.	30 days
Secondary	hs-troponin levels	To compare hs-troponin levels as % above the upper reference limit [URL]) among the two groups.	30 days
Secondary	Acute Respiratory Distress Syndrome	To compare the incidence of SARS-CoV-2-related Acute Respiratory Distress Syndrome (ARDS) between the two groups.	30 days
Secondary	Hospital stay	To compare length of hospital stay between the two groups.	30 days
Secondary	Right ventricular function	To compare measures of right ventricular function at trans-thoracic echocardiography or CT between admission and follow-up, whenever available	30 days
Secondary	Number of pulmonary embolism events	Pulmonary embolism events diagnosed by computed tomography scan	30 days