Therapeutic versus Prophylactic Bemiparin in Hospitalized Patients with Nonsevere COVID-19 Pneumonia (BEMICOP Study): An Open-Label, Multicenter, Randomized, Controlled Trial
| Autor: | Jorge M. Núñez-Córdoba, Pilar Llamas, Jose Yuste, Ramón Lecumberri, Juana Schwartz, Félix Alegre, David Filella, Javier Fernández-García, Belén Sádaba, Víctor Jiménez-Yuste, Francisco Carmona-Torre, María Marcos, Pedro Ruiz-Artacho, Cristina Carbonell, Rosa Vidal Laso |
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| Rok vydání: | 2021 |
| Předmět: |
prophylactic therapeutic
Male medicine.medical_specialty medicine.drug_class medicine.medical_treatment Low molecular weight heparin outcomes Severity of Illness Index law.invention Fibrin Fibrinogen Degradation Products Randomized controlled trial law Internal medicine Medicine Humans Aged Mechanical ventilation business.industry SARS-CoV-2 low molecular weight heparin Absolute risk reduction COVID-19 Hematology Odds ratio Pneumonia Heparin Low-Molecular-Weight Middle Aged Interim analysis Intensive care unit Respiration Artificial Survival Analysis COVID-19 Drug Treatment Clinical trial Hospitalization Treatment Outcome Female business |
| Zdroj: | THROMBOSIS AND HAEMOSTASIS r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname |
| ISSN: | 2567-689X 0340-6245 |
| Popis: | Thromboprophylaxis with low molecular weight heparin in hospitalized patients with COVID-19 is mandatory, unless contraindicated. Given the links between inflammation and thrombosis, the use of higher doses of anticoagulants could improve outcomes. We conducted an open-label, multicenter, randomized, controlled trial in adult patients hospitalized with nonsevere COVID-19 pneumonia and elevated D-dimer. Patients were randomized to therapeutic-dose bemiparin (115 IU/kg daily) versus standard prophylaxis (bemiparin 3,500 IU daily), for 10 days. The primary efficacy outcome was a composite of death, intensive care unit admission, need of mechanical ventilation support, development of moderate/severe acute respiratory distress, and venous or arterial thrombosis within 10 days of enrollment. The primary safety outcome was major bleeding (International Society on Thrombosis and Haemostasis criteria). A prespecified interim analysis was performed when 40% of the planned study population was reached. From October 2020 to May 2021, 70 patients were randomized at 5 sites and 65 were included in the primary analysis; 32 patients allocated to therapeutic dose and 33 to standard prophylactic dose. The primary efficacy outcome occurred in 7 patients (22%) in the therapeutic-dose group and 6 patients (18%) in the prophylactic-dose (absolute risk difference 3.6% [95% confidence interval [CI], –16% –24%]; odds ratio 1.26 [95% CI, 0.37–4.26]; p = 0.95). Discharge in the first 10 days was possible in 66 and 79% of patients, respectively. No major bleeding event was registered. Therefore, in patients with COVID-19 hospitalized with nonsevere pneumonia but elevated D-dimer, the use of a short course of therapeutic-dose bemiparin does not appear to improve clinical outcomes compared with standard prophylactic doses. Trial Registration: ClinicalTrials.gov NCT04604327. |
| Databáze: | OpenAIRE |
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