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Efficacy and Safety of Tinzaparin in Prophylactic, Intermediate and Therapeutic Doses in Non-Critically Ill Patients Hospitalized with COVID-19: The PROTHROMCOVID Randomized Controlled Trial

2022; Multidisciplinary Digital Publishing Institute; Volume: 11; Issue: 19 Linguagem: Inglês

10.3390/jcm11195632

2077-0383

Nuria Muñoz‐Rivas, Jesús Aibar, Cristina Gabara-Xancó, Ángela Trueba-Vicente, Ana Urbelz-Pérez, Vicente Gómez del Olmo, Pablo Demelo‐Rodríguez, Alberto Rivera-Gallego, Pau Bosch‐Nicolau, Montserrat Pérez‐Pinar, Mónica Ríos-Prego, Olga Madridano-Cobo, Laura Ramos-Alonso, Jesús Alonso‐Carrillo, Iria Francisco-Albelsa, Edelmira Martí, Ana Maestre-Peiró, Manuel Méndez‐Bailón, José‐Ángel Hernández‐Rivas, Juan Torres‐Macho,

Thermal Regulation in Medicine

Hospitalized patients with COVID-19 are at increased risk of thrombosis, acute respiratory distress syndrome and death. The optimal dosage of thromboprophylaxis is unknown. The aim was to evaluate the efficacy and safety of tinzaparin in prophylactic, intermediate, and therapeutic doses in non-critical patients admitted for COVID-19 pneumonia. PROTHROMCOVID is a randomized, unblinded, controlled, multicenter trial enrolling non-critical, hospitalized adult patients with COVID-19 pneumonia. Patients were randomized to prophylactic (4500 IU), intermediate (100 IU/kg), or therapeutic (175 IU/kg) groups. All tinzaparin doses were administered once daily during hospitalization, followed by 7 days of prophylactic tinzaparin at discharge. The primary efficacy outcome was a composite endpoint of symptomatic systemic thrombotic events, need for invasive or non-invasive mechanical ventilation, or death within 30 days. The main safety outcome was major bleeding at 30 days. Of the 311 subjects randomized, 300 were included in the prespecified interim analysis (mean [SD] age, 56.7 [14.6] years; males, 182 [60.7%]). The composite endpoint at 30 days from randomization occurred in 58 patients (19.3%) of the total population; 19 (17.1 %) in the prophylactic group, 20 (22.1%) in the intermediate group, and 19 (18.5%) in the therapeutic dose group (