RESUMO
BACKGROUND: Preliminary data highlights the importance of anticoagulation therapy in the prevention and treatment of thromboembolism in SARS CoV-2 infection. There is insufficient data comparing the safety and efficacy of direct oral anticoagulants (DOACs) and subcutaneous enoxaparin in the prophylactic management of COVID-19 associated thromboembolic disease, particularly in mild to moderate cases of COVID-19 infection. OBJECTIVES: The study was designed to investigate the efficacy of oral rivaroxaban as a prophylactic anticoagulant in mild to moderate SARS CoV-2 infection. METHODS: In this randomized, open-label, prospective superiority trial involving hospitalized patients with confirmed mild or moderate COVID-19 disease without known thromboembolism, we assigned 230 patients to receive either once-daily oral rivaroxaban (10mg or 15mg) or once-daily subcutaneous enoxaparin (40mg or 60mg) for a median duration of 8 days. The primary outcome was a composite of all major, clinically relevant haemorrhagic and thrombotic events. RESULTS: The primary efficacy outcome occurred in 4 of 115 patients in the rivaroxaban group (3.5%) versus 16 of 113 patients in the enoxaparin group (14.2%) (hazard ratio 0.207, 95% confidence interval [CI], 0.069 to 0.621, P=0.005). Adverse events developed in 4.3% of patients in the study group and 12.4% in the enoxaparin group (hazard ratio 0.328; 95% CI, 0.118 to 0.910; P=0.032). Major bleeding was seen in 1 patient (0.9%) in the rivaroxaban group and 3 patients (2.7%) in the enoxaparin group. CONCLUSIONS: Rivaroxaban alone was superior to enoxaparin for the prophylactic management of coagulopathy associated with mild to moderate SARS CoV-2 infection.