Efficacy and Safety of a New Selective Oral Factor Xa Inhibitor Amidine Hydrochloride for Prevention of Thromboembolic Events in Hospitalized Patients with COVID-19: a Multiple-Center Prospective Randomized Controlled Study

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Objective. To evaluate the effectiveness and safety of a new selective oral factor Xa inhibitor amidine hydrochloride (DD217) as compared to enoxaparin sodium in prevention of venous thromboembolic events (VTE) in patients hospitalized with COVID-19. Material and methods. A multipla-center prospective randomized controlled trial AM217_03 (clinicaltrials.gov identifier NCT05185804) included 401 patients hospitalized with the novel coronavirus infection COVID-19. Patients randomized to group 1 (n=198) received amidine hydrochloride orally at a dose of 60 mg once a day. Patients randomized to group 2 (n=202) received enoxaparin sodium subcutaneously at a dose of 40 mg once daily. The primary end point characterizing the effectiveness was the overall number of cases of thromboembolic events, including VTE. The primary endpoint characterizing safety was the incidence of major and clinically significant non-major bleedings during the study therapy (maximum 30 days). Results. The efficacy analysis included data from 177 patients in group 1 and 194 in group 2. No thrombotic events as part of the composite primary endpoint was observed during study therapy in the amidine hydrochloride group and was reported in 7 patients in the enoxaparin sodium group (3.61%; p=0.015). At the same time, the proportion of patients requiring intensive care due to worsening COVID-19 or the occurrence of complications during study therapy was 17 (8.7%) in the amidine hydrochloride group and 10 (5.0%) in the enoxaparin group (p=0.14). No major and clinically significant non-major bleeding was registered in the amidine hydrochloride group compared with 1.0% (2 patients) in the enoxaparin sodium group (p=0.499). Conclusion. In hospitalized patients with COVID-19 who did not require an intensive care stay, oral factor Xa inhibitor amidine hydrochloride 60 mg once daily was noninferior to subcutaneous enoxaparin sodium 40 mg once daily in preventing thromboembolic complications, demonstrating a trend towards superior effectiveness in the prevention of VTE. Amidine hydrochloride demonstrated a safety profile comparable to enoxaparin in relation to major and clinically significant non-major bleeding.

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