Azvudine has been designated as a priority treatment for patients infected with SARS-CoV-2, however, clinical evidence in hospitalized cases remains insufficient. We performed a multi-center, retrospective cohort study to evaluate effectiveness and safety of azvudine in hospitalized patients with SARS-CoV-2 in China (NCT06349655). Kaplan-Meier method, Cox regression model, subgroup analysis and seven sensitive analyses were employed. A total of 32864 hospitalized patients with SARS-CoV-2 were enrolled, in which 5735 azvudine recipients and 5735 controls were selected using 1:1 propensity score matching. Based on Kaplan-Meier analysis, azvudine significantly reduced rates of all-cause death (P < 0.0001) and composite disease progression (P = 0.00019). Cox regression analysis demonstrated that hazard ratios of all-cause death and composite disease progression were 0.68 (95%CI: 0.598-0.775, P < 0.001) and 0.88 (95% CI: 0.795-0.976, P = 0.016), respectively. Subgroup analysis showed preference of azvudine for patients receiving antibiotics in reducing all-cause death and composite disease progression. Seven sensitivity analyses verified the robustness of our results. Safety analysis on adverse events showed no significant difference between both groups. This study suggested that azvudine may reduce all-cause death and composite disease progression in hospitalized patients with SARS-CoV-2 infection without serious adverse events. However, the findings are susceptible to some potential biases, and further studies still need to identify the efficacy of azvudine.
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