The effectiveness and safety of azvudine treatment in COVID‐19 patients with kidney disease based on a multicenter retrospective cohort study

Abstract Kidney disease has been the main risk factor of poor prognosis for COVID‐19 patients. The effectiveness and safety of azvudine treatment in COVID‐19 patients with kidney disease have not been reported. Herein, we conducted a nine‐center and retrospective cohort study in China (ClinicalTrials: NCT06349655) that enrolled 32,864 hospitalized COVID‐19 patients, in which 4192 patients were pre‐existed with kidney disease. After exclusions and propensity score matching, a total of 831 kidney disease patients treated with azvudine and 831 kidney disease patients treated without any anti‐viral treatment (normal group) were selected. Based on Kaplan–Meier and Cox regression analysis, we found that azvudine administration had significantly decreased risks of all‐cause death ( p < 0.0001) and composite disease progression ( p = 0.012) as compared to the normal group. Multivariate Cox proportional hazards regression analysis demonstrated that the hazard ratio of all‐cause death was 0.64 (95% CI: 0.503–0.826, p < 0.001) and the hazard ratio of composite disease progression was 0.81 (95% CI: 0.658–1.004, p = 0.05). The subgroup analysis of different characteristics indicated no significant influence of single factor in both all‐cause mortality and composite disease progression. Five sensitivity analyses were employed to verify the robustness of our results. Safety analysis based on adverse event rate demonstrated an increased rate of hypertriglyceridemia after azvudine administration. In conclusion, we are the first to report the effectiveness and safety of azvudine treatment in COVID‐19 patients with kidney disease and demonstrate that azvudine could reduce the risk of all‐cause death without significant adverse events based on a large‐scale, multicenter, retrospective cohort study.