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J Thorac Dis
. 2025 Oct 31;17(10):8313-8322.
doi: 10.21037/jtd-2025-486. Epub 2025 Oct 24. The efficacy of azvudine in treating hospitalized COVID-19 patients: a retrospective single-center cohort analysis
Hong Lei # 1 , Ya-Wen Ye # 2 , Yue-Juan Zhou 1 , Yan-Fei Mao 1 , Yu Fang 1 , Pei-Pei Chen 1 , Wen-Wen You 1 , Shu Li 1 , Yan-Yan Xu 1
Affiliations
Background: Although coronavirus disease 2019 (COVID-19) is no longer classified as a Public Health Emergency of International Concern (PHEIC), the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to undergo genetic mutations, leading to persistent public health challenges. It is still necessary to evaluate the effectiveness and safety of existing clinical drug treatments. In this study, we mainly evaluate the treatment effect of azvudine in the real world of hospitalized COVID-19 patients.
Methods: This retrospective cohort analysis included hospitalized patients diagnosed with COVID-19 from December 1, 2022, to October 31, 2023. Patients receiving azvudine were categorized as the treatment group, while those without antiviral therapy constituted the control group. The primary endpoint was the rate of composite outcome of disease progression within a 38-day observation period. Secondary endpoints included all-cause mortality, incidence of intensive care unit (ICU) admission, and the rate of receiving ventilator-assisted ventilation.
Results: Of 939 hospitalized COVID-19 patients, 260 were included in the final analysis after exclusions and propensity score matching (1:1), with 130 in each group. In the azvudine group, only one patient required invasive ventilation, was admitted to ICU, and ultimately passed away. In the matched control group, the rate of the composite outcome of disease progression was 9.23% (12/130), the all-cause mortality was 5.38% (7/130), the incidence of ICU admission was 5.38% (7/130), and the incidence of receiving ventilator-assisted ventilation was 6.15% (8/130). The treatment of azvudine showed a significant reduction in the endpoints, including the rate of the composite outcome of disease progression (P=0.02) and receiving ventilator-assisted ventilation (P=0.047). Azvudine was linked to a lower combined risk of disease progression [hazard ratio (HR): 0.08, 95% confidence interval (CI): 0.01 to 0.62] and ventilator-assisted ventilation needs (HR: 0.12, 95% CI: 0.02 to 0.97). It reduced the risk of composite outcome of disease progression [absolute risk reduction (ARR): 0.08, 95% CI: 0.02 to 0.15; number needed to treat (NNT): 12, 95% CI: 7 to 50].
Conclusions: The findings show that azvudine is effective in treating hospitalized COVID-19 patients. It could be considered for therapeutic use in this patient population.
Keywords: Coronavirus disease 2019 (COVID-19); all-cause mortality; azvudine; composite outcome.
. 2025 Oct 31;17(10):8313-8322.
doi: 10.21037/jtd-2025-486. Epub 2025 Oct 24. The efficacy of azvudine in treating hospitalized COVID-19 patients: a retrospective single-center cohort analysis
Hong Lei # 1 , Ya-Wen Ye # 2 , Yue-Juan Zhou 1 , Yan-Fei Mao 1 , Yu Fang 1 , Pei-Pei Chen 1 , Wen-Wen You 1 , Shu Li 1 , Yan-Yan Xu 1
Affiliations
- PMID: 41229877
- PMCID: PMC12603486
- DOI: 10.21037/jtd-2025-486
Background: Although coronavirus disease 2019 (COVID-19) is no longer classified as a Public Health Emergency of International Concern (PHEIC), the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to undergo genetic mutations, leading to persistent public health challenges. It is still necessary to evaluate the effectiveness and safety of existing clinical drug treatments. In this study, we mainly evaluate the treatment effect of azvudine in the real world of hospitalized COVID-19 patients.
Methods: This retrospective cohort analysis included hospitalized patients diagnosed with COVID-19 from December 1, 2022, to October 31, 2023. Patients receiving azvudine were categorized as the treatment group, while those without antiviral therapy constituted the control group. The primary endpoint was the rate of composite outcome of disease progression within a 38-day observation period. Secondary endpoints included all-cause mortality, incidence of intensive care unit (ICU) admission, and the rate of receiving ventilator-assisted ventilation.
Results: Of 939 hospitalized COVID-19 patients, 260 were included in the final analysis after exclusions and propensity score matching (1:1), with 130 in each group. In the azvudine group, only one patient required invasive ventilation, was admitted to ICU, and ultimately passed away. In the matched control group, the rate of the composite outcome of disease progression was 9.23% (12/130), the all-cause mortality was 5.38% (7/130), the incidence of ICU admission was 5.38% (7/130), and the incidence of receiving ventilator-assisted ventilation was 6.15% (8/130). The treatment of azvudine showed a significant reduction in the endpoints, including the rate of the composite outcome of disease progression (P=0.02) and receiving ventilator-assisted ventilation (P=0.047). Azvudine was linked to a lower combined risk of disease progression [hazard ratio (HR): 0.08, 95% confidence interval (CI): 0.01 to 0.62] and ventilator-assisted ventilation needs (HR: 0.12, 95% CI: 0.02 to 0.97). It reduced the risk of composite outcome of disease progression [absolute risk reduction (ARR): 0.08, 95% CI: 0.02 to 0.15; number needed to treat (NNT): 12, 95% CI: 7 to 50].
Conclusions: The findings show that azvudine is effective in treating hospitalized COVID-19 patients. It could be considered for therapeutic use in this patient population.
Keywords: Coronavirus disease 2019 (COVID-19); all-cause mortality; azvudine; composite outcome.