Antiviral effectiveness and safety of azvudine in hospitalized SARS-CoV-2 patients with pre-existing chronic respiratory diseases: A multicenter, retrospective cohort study

Although azvudine has become a priority in the treatment of SARS-CoV-2, its effectiveness and safety among COVID-19 patients who already have chronic respiratory diseases (CRDs) have not been sufficiently validated. A retrospective, multicenter cohort study involving 10 hospitals in Henan Province was performed to assess inpatients with COVID-19 and CRDs (Clinical Trial Registration Number: NCT06349655). Azvudine recipients and the control group were matched at a 1:1 ratio using propensity scores. The clinical outcomes (all-cause death and composite disease progression) were analyzed using Kaplan-Meier and Cox regression analyses, with additional subgroup and sensitivity analyses performed. Eighteen clinical features were included to construct a nomogram for predicting the survival of inpatients with COVID-19 and CRDs. Out of 37,606 hospitalized COVID-19 patients, 1462 azvudine recipients and 1462 matched controls were included in the analysis. The results of Kaplan-Meier and multivariate Cox regression analyses demonstrated that in contrast to the controls, azvudine use was associated with a decreased risk of all-cause death in patients with COVID-19 and pre-existing CRDs (log-rank: p = .012; HR: 0.73; 95% CI: 0.553-0.956); but was not significantly different in terms of composite disease progression (log-rank: p = .82; HR: 1.15; 95% CI: 0.948-1.383). An analysis of subgroups and three sensitivity appraisals validate the above outcomes. The number and type of adverse events associated with azvudine treatment were acceptable. The concordance index (0.8499, 0.8497) and area under the curve (86.1%, 80.4%) of the nomogram showed satisfactory discriminative ability in the training and test sets. Azvudine could be effective in reducing all-cause death among inpatients with COVID-19 and CRDs and had few serious adverse events.