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Therapeutic versus Prophylactic Bemiparin in Hospitalized Patients with Nonsevere COVID-19 Pneumonia (BEMICOP Study): An Open-Label, Multicenter, Randomized, Controlled Trial.
Marcos-Jubilar, María; Carmona-Torre, Francisco; Vidal, Rosa; Ruiz-Artacho, Pedro; Filella, David; Carbonell, Cristina; Jiménez-Yuste, Víctor; Schwartz, Juana; Llamas, Pilar; Alegre, Félix; Sádaba, Belén; Núñez-Córdoba, Jorge; Yuste, José R; Fernández-García, Javier; Lecumberri, Ramón.
  • Marcos-Jubilar M; Hematology Service, Clínica Universidad de Navarra, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.
  • Carmona-Torre F; Divison of Infectious Diseases, Clínica Universidad de Navarra, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.
  • Vidal R; Hematology Service, Hospital Universitario Fundación Jiménez-Díaz, Madrid, Spain.
  • Ruiz-Artacho P; Internal Medicine Department, Clínica Universidad de Navarra, Madrid, Spain.
  • Filella D; CIBER Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.
  • Carbonell C; Internal Medicine Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
  • Jiménez-Yuste V; Internal Medicine Department, Hospital Universitario de Salamanca-IBSAL, Universidad de Salamanca, Salamanca, Spain.
  • Schwartz J; Hematology Service, Hospital Universitario La Paz, Madrid, Spain.
  • Llamas P; Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.
  • Alegre F; Hematology Service, Hospital Universitario Fundación Jiménez-Díaz, Madrid, Spain.
  • Sádaba B; Internal Medicine Department, Clínica Universidad de Navarra, Pamplona, Spain.
  • Núñez-Córdoba J; Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.
  • Yuste JR; Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.
  • Fernández-García J; Divison of Infectious Diseases, Clínica Universidad de Navarra, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.
  • Lecumberri R; Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain.
Thromb Haemost ; 122(2): 295-299, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1595734
ABSTRACT
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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia / Heparin, Low-Molecular-Weight / SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Randomized controlled trials Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: Thromb Haemost Year: 2022 Document Type: Article Affiliation country: A-1667-7534

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia / Heparin, Low-Molecular-Weight / SARS-CoV-2 / COVID-19 Type of study: Controlled clinical trial / Randomized controlled trials Limits: Aged / Female / Humans / Male / Middle aged Language: English Journal: Thromb Haemost Year: 2022 Document Type: Article Affiliation country: A-1667-7534