Thromb Haemost
DOI: 10.1055/a-1667-7534
Original Article

Therapeutic vs. prophylactic bemiparin in hospitalized patients with non-severe COVID-19 (BEMICOP): an open-label, multicenter, randomized trial

Therapeutic vs. prophylactic bemiparin in COVID-19
María Marcos
1  Hematology, University Clinic of Navarra, Pamplona, Spain
,
Francisco Carmona-Torre
2  Clínica Universidad de Navarra, Pamplona, Spain (Ringgold ID: RIN16755)
,
Rosa Vidal Laso
3  Hematology, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain (Ringgold ID: RIN16436)
,
4  Internal Medicine, Clínica Universidad de Navarra, Madrid, Spain
,
David Filella
5  Internal Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (Ringgold ID: RIN16689)
,
Cristina Carbonell
6  Internal Medicine, Hospital Universitario de Salamanca, Salamanca, Spain (Ringgold ID: RIN37479)
,
Victor Jimenez-Yuste
7  Hematology, Hospital Universitario La Paz, Madrid, Spain
,
Juana Schwartz
8  Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain (Ringgold ID: RIN16755)
,
Pilar Llamas
9  Haematolgy, Fundación Jiménez Díaz, Madrid, Spain
,
Félix Alegre
10  Internal Medicine, Clínica Universidad de Navarra, Pamplona, Spain (Ringgold ID: RIN16755)
,
Belén Sádaba
8  Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain (Ringgold ID: RIN16755)
,
Jorge Núñez-Córdoba
8  Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain (Ringgold ID: RIN16755)
,
José Ramón Yuste
11  Infectious Diseases, Clínica Universidad de Navarra, Pamplona, Spain (Ringgold ID: RIN16755)
,
Javier Fernández-García
8  Clinical Trials Unit, Clínica Universidad de Navarra, Pamplona, Spain (Ringgold ID: RIN16755)
,
Ramón Lecumberri
12  Hematology, University Clinic of Navarra, Pamplona, Spain
› Author Affiliations
Clinical Trials Registration: ClinicalTrials.gov NCT04604327

Thrombophylaxis with low molecular weight heparin (LMWH) 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 non-severe COVID-19 pneumonia and elevated D-dimer. Patients were randomized to therapeutic-dose bemiparin (115 IU/Kg daily) vs. 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 (ISTH 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 (21.9%) in the therapeutic-dose group and 6 patients (18.2%) in the prophylactic-dose (absolute risk difference 3.6% [95% 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 non-severe pneumonia but elevated D-dimer, the use of a short course of therapeutic-dose bemiparin did not improve clinical outcomes compared to standard prophylactic doses.



Publication History

Received: 21 August 2021

Accepted after revision: 10 October 2021

Publication Date:
12 October 2021 (online)

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