Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Grand Est Region | UNKNOWN |
| University Hospital of Saint-Etienne | OTHER |
Not provided
Not provided
Not provided
Worldwide observational studies indicate a significant prothrombogenic effect associated with SARS-CoV-2 infection with a high incidence of venous thromboembolism (VTE), notably life-threatening pulmonary embolism.
According to recommendations for acute medical illnesses, all COVID-19 hospitalized patients should be given VTE prophylaxis such as a low molecular weight heparin (LMWH). A standard prophylactic dose (eg. Enoxaparin 4000IU once daily) could be insufficient in obese patients and VTE has been reported in patients treated with a standard prophylactic dose.
In COVID-19 patients, guidelines from several international societies confirm the existence of an hypercoagulability and the importance of thromboprophylaxis but the "optimal dose is unknown" and comparative studies are needed.
In view of these elements, carrying out a trial comparing various therapeutic strategies for the prevention of VTE in hospitalized patients with COVID-19 constitutes a health emergency.
Thus, we hypothesize that an increased prophylactic dose of weight-adjusted LMWH would be greater than a lower prophylactic dose of LMWH to reduce the risk of life-threatening VTE in hospitalized patients. The benefit-risk balance of this increase dose will be carefully evaluated because of bleeding complications favored by possible renal / hepatic dysfunctions, drug interactions or invasive procedures in COVID-19 patients.
This multicenter randomized (1:1) open-label controlled trial will randomize hospitalized adults with COVID-19 infection to weight-adjusted prophylactic dose vs. lower prophylactic dose of LMWH.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Prophylactic Dose of Low Molecular Weight Heparin | Active Comparator | Enoxaparin, Tinzaparin, Nadroparin, Dalteparin |
|
| Weight-Adjusted Prophylactic Dose Low Molecular Weight Heparin | Experimental | Enoxaparin, Tinzaparin, Nadroparin, Dalteparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | For example (Enoxaparin):
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous thromboembolism | Risk of deep vein thrombosis or pulmonary embolism or venous thromboembolism-related death | hospitalization stay (up to 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding | Risk of major bleeding defined by the ISTH | hospitalization stay (up to 28 days) |
| Major Bleeding and Clinically Relevant Non-Major Bleeding | Risk of Major Bleeding and Clinically Relevant Non-Major Bleeding Defined by the ISTH |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| El Mehdi Siaghy | Research and Innovation Department, Nancy University Hospital | Study Director |
| Stéphane Zuily, MD, PhD | Nancy Academic Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens Academic Hospital | Amiens | France | ||||
| Besançon Academic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37350990 | Result | Zuily S, Lefevre B, Sanchez O, Empis de Vendin O, de Ciancio G, Arlet JB, Khider L, Terriat B, Greigert H, Robert CS, Louis G, Trinh-Duc A, Rispal P, Accassat S, Thiery G, Montani D, Azarian R, Meneveau N, Soudet S, Le Mao R, Maurier F, Le Moing V, Quere I, Yelnik CM, Lefebvre N, Martinot M, Delrue M, Benhamou Y, Parent F, Roy PM, Presles E, Goehringer F, Mismetti P, Bertoletti L, Rossignol P, Couturaud F, Wahl D, Thilly N, Laporte S; COVI-DOSE investigators. Effect of weight-adjusted intermediate-dose versus fixed-dose prophylactic anticoagulation with low-molecular-weight heparin on venous thromboembolism among noncritically and critically ill patients with COVID-19: the COVI-DOSE trial, a multicenter, randomised, open-label, phase 4 trial. EClinicalMedicine. 2023 Jun;60:102031. doi: 10.1016/j.eclinm.2023.102031. Epub 2023 Jun 9. | |
| 35244208 |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Multicenter randomized (1:1) controlled open-label trial, stratified on disease severity (admission to ICU or not)
Not provided
Not provided
Not provided
|
| Enoxaparin | Drug | For example (Enoxaparin): From 4000IU once a day in patients admitted in medical ward to 4000IU twice a day in patients admitted in the ICU. In patients with severe renal insufficiency (GFR=15-30 mL/min/1.73m²), LMWH doses will be reduced by 50%. |
|
|
| hospitalization stay (up to 28 days) |
| Net Clinical Benefit | Risk of Venous Thromboembolism and Major Bleeding | hospitalization stay (up to 28 days) and 60 days |
| Venous Thromboembolism at other sites | Risk of venous thrombosis at other sites: e.g. superficial vein, catheters, hemodialysis access, ECMO, splanchnic, encephalic, upper limb | hospitalization stay (up to 28 days) |
| Arterial Thrombosis | Risk of arterial thrombosis at any sites | hospitalization stay (up to 28 days) |
| All-Cause Mortality | Risk of all-cause mortality | hospitalization stay (up to 28 days) and 60 days |
| Factors associated with the risk of venous thromboembolism | Identification of associations between the risk of venous thromboembolism and clinical (eg. past medical history of thrombosis, cardiovascular risk factors, treatments, severity of COVID-19) and laboratory variables (e.g. D-dimers, fibrinogen, CRP) collected in the eCRF | hospitalization stay (up to 28 days) |
| Besançon |
| France |
| Brest Academic Hospital | Brest | France |
| Civil Hospital | Colmar | France |
| Dijon Academic Hospital | Dijon | France |
| Kremlin Bicêtre Academic Hospital | Le Kremlin-Bicêtre | France |
| Lille Academic Hospital | Lille | France |
| Groupe Hospitalier Unéos | Metz | France |
| Metz-Thionville Regional Hospital | Metz | France |
| Montpellier Academic Hospital | Montpellier | France |
| Emile Muller Hospital | Mulhouse | France |
| Nancy Academic Hospital | Nancy | France |
| George Pompidou European Hospital | Paris | France |
| Lariboisière Academic Hospital | Paris | France |
| St Etienne Academic Hospital | Saint-Etienne | France |
| Strasbourg Academic Hospital | Strasbourg | France |
| Toulouse Academic Hospital | Toulouse | France |
| 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. |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D011655 | Pulmonary Embolism |
| D020246 | Venous Thrombosis |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D013923 | Thromboembolism |
Not provided
Not provided
| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D000078222 | Tinzaparin |
| D017762 | Nadroparin |
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided