A multicenter, real-world cohort study: effectiveness and safety of Azvudine in hospitalized COVID-19 patients with pre-existing diabetes.

Introduction: During the Omicron infection wave, diabetic patients are susceptible to COVID-19, which is linked to a poor prognosis. However, research on the real-world effectiveness and safety of Azvudine, a common medication for COVID-19, is insufficient in those with pre-existing diabetes.

Methods: In this retrospective study, we included 32,864 hospitalized COVID-19 patients from 9 hospitals in Henan Province. Diabetic patients were screened and divided into the Azvudine group and the control group, via 1:1 propensity score matching. The primary outcome was all-cause mortality, and the secondary outcome was composite disease progression. Laboratory abnormal results were used for safety evaluation.

Results: A total of 1,417 patients receiving Azvudine and 1,417 patients receiving standard treatment were ultimately included. Kaplan-Meier curves suggested that all-cause mortality (P = 0.0026) was significantly lower in the Azvudine group than in the control group, but composite disease progression did not significantly differ (P = 0.1). Cox regression models revealed Azvudine treatment could reduce 26% risk of all-cause mortality (95% CI: 0.583-0.942, P = 0.015) versus controls, and not reduce the risk of composite disease progression (HR: 0.91, 95% CI: 0.750-1.109, P = 0.355). The results of subgroup analysis and three sensitivity analyses were consistent with the previous findings. Safety analysis revealed that the incidence rates of most adverse events were similar between the two groups.

Conclusion: In this study, Azvudine demonstrated good efficacy in COVID-19 patients with diabetes, with a lower all-cause mortality rate. Additionally, the safety was favorable. This study may provide a new strategy for the antiviral management of COVID-19 patients with diabetes.