Real-world effectiveness and safety of Azvudine in hospitalized patients with SARS-CoV-2 infection: a multicenter, retrospective cohort study
Ph.D Zhigang Ren, Mengzhao Yang, Guanyue Su, Guowu Qian, Yiqiang Yuan, Jia Yu, Silin Li, Changshuang Wang, Mingxia Lu, Hong Luo, Shixi Zhang, Guangming Li, Donghua Zhang, Ling Wang, Guotao Li, Xiaoli Jin, Juan Wang, Mingming Wang, Ming Cheng, Haiyu Wang, Prof Junbiao Chang, Prof Zujiang Yu
Journal of Infection, doi:10.1016/j.jinf.2024.106355
Objectives Azvudine has been designated as a priority treatment for patients infected with SARS-CoV-2, however, clinical evidence in hospitalized cases remains insufficient.
Methods 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. Results 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.
Conclusions 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.
Contributors Zhigang Ren, Mengzhao Yang, Guanyue Su, Guowu Qian, and Yiqiang Yuan contributed equally to this work. Zhigang Ren, Junbiao Chang and Zujiang Yu conceived and designed the study; Zujiang Yu, Zhigang Ren, Guowu Qian, Yiqiang Yuan, Silin Li, Hong Luo, Shixi Zhang, Guangming Li, Donghua Zhang, and Guotao Li managed the patients; Mengzhao Yang, Guanyue Su, Jia Yu, Haiyu Wang, Ming Cheng, Ling Wang, Guowu Qian, Xiaoli Jin, Juan Wang and Mingming Wang collected and verified the underlying data; Changshuang Wang and Mingxia Lu collected the vaccination data; Mengzhao Yang, and Jia Yu analyzed the data; Guanyue Su wrote the manuscript. All authors had full access to all the data in the study and agree to submit the manuscript for publication.
Declaration of Competing Interest The authors declare no competing interests that could have appeared to influence the work reported in this paper.
Ethics approval and consent to participate This study was reviewed and approved by the Institutional Review Board from The First Affiliated Hospital of Zhengzhou University (2023-KY-0865-001). The study was registered with ClinicalTrials.gov (NCT06349655). All participants in the retrospective study were anonymous and did not need individual informed consent.
Declaration of Competing Interest ☒ The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. ☐ The author is an..
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