Covid19
Conditions
Keywords
COVID19
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.
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.
Interventions
DRUGEnoxaparin
Subcutaneous enoxaparin
Sponsors
Niguarda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of venous thromboembolism detected by imaging | 30 days | Deep vein thrombosis events diagnosed by serial compression ultrasonography and pulmonary embolism events diagnosed by computed tomography scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of deep venous thrombosis events | 30 days | Deep venous thrombosis events diagnosed by serial compression ultrasonography |
| Sequential organ failure assessment | 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. |
| C-reactive protein | 30 days | To compare C-reactive protein levels as % above the upper reference limit \[URL\]) among the two groups. |
| Interleukin-6 | 30 days | To compare Interleukin-6 levels as % above the upper reference limit \[URL\]) among the two groups. |
| D-dimer | 30 days | To D-dimer compare levels as % above the upper reference limit \[URL\]) among the two groups. |
| In hospital major complications | 30 days | death, venous thromboembolism, use of mechanical ventilation, stroke, acute myocardial infarction and admission to an intensive care |
| Acute Respiratory Distress Syndrome | 30 days | To compare the incidence of SARS-CoV-2-related Acute Respiratory Distress Syndrome (ARDS) between the two groups. |
| Hospital stay | 30 days | To compare length of hospital stay between the two groups. |
| Right ventricular function | 30 days | To compare measures of right ventricular function at trans-thoracic echocardiography or CT between admission and follow-up, whenever available |
| Number of pulmonary embolism events | 30 days | Pulmonary embolism events diagnosed by computed tomography scan |
| hs-troponin levels | 30 days | To compare hs-troponin levels as % above the upper reference limit \[URL\]) among the two groups. |
Countries
Italy
Outcome results
None listed