Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 40 mg subcutaneous enoxaparin o.d. | Active Comparator | Effects of 40 mg subcutaneous enoxaparin o.d. |
|
| 40 mg subcutaneous enoxaparin b.i.d | Active Comparator | Effects of 40 mg subcutaneous enoxaparin b.i.d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | Subcutaneous enoxaparin |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| In hospital major complications | death, venous thromboembolism, use of mechanical ventilation, stroke, acute myocardial infarction and admission to an intensive care | 30 days |
| Number of deep venous thrombosis events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda | Milan | 20162 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35244208 | Derived | Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. | |
| 33502773 | Derived | Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
Not provided
Not provided
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.
Not provided
Not provided
Open label
Not provided
Deep venous thrombosis events diagnosed by serial compression ultrasonography
| 30 days |
| 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 |
| C-reactive protein | To compare C-reactive protein levels as % above the upper reference limit [URL]) among the two groups. | 30 days |
| Interleukin-6 | To compare Interleukin-6 levels as % above the upper reference limit [URL]) among the two groups. | 30 days |
| D-dimer | To D-dimer compare levels as % above the upper reference limit [URL]) among the two groups. | 30 days |
| hs-troponin levels | To compare hs-troponin levels as % above the upper reference limit [URL]) among the two groups. | 30 days |
| Acute Respiratory Distress Syndrome | To compare the incidence of SARS-CoV-2-related Acute Respiratory Distress Syndrome (ARDS) between the two groups. | 30 days |
| Hospital stay | To compare length of hospital stay between the two groups. | 30 days |
| 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 |
| Number of pulmonary embolism events | Pulmonary embolism events diagnosed by computed tomography scan | 30 days |
| 32407672 | Derived | Levi M, Thachil J, Iba T, Levy JH. Coagulation abnormalities and thrombosis in patients with COVID-19. Lancet Haematol. 2020 Jun;7(6):e438-e440. doi: 10.1016/S2352-3026(20)30145-9. Epub 2020 May 11. No abstract available. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002241 |
| Carbohydrates |