Evaluating the effectiveness and safety of Azvudine for hospitalised patients with COVID-19 and hypertension: a multicenter retrospective cohort study
et al., Scientific Reports, doi:10.1038/s41598-025-34514-1, NCT06349655, Feb 2026
Azvudine for COVID-19
48th treatment shown to reduce risk in
January 2023, now with p = 0.0000000041 from 40 studies.
No treatment is 100% effective. Protocols
combine treatments.
6,400+ studies for
210+ treatments. c19early.org
|
PSM retrospective 4,868 hospitalized COVID-19 patients with hypertension showing reduced mortality with azvudine.
For composite disease progression, the azvudine group had more raw events (330) than the control group (320) out of identical starting populations (2434 per group). Yet, the study reports a significantly protective Hazard Ratio (0.84). The data suggests a large differential in person-days driven by informative censoring (e.g., early discharge of control patients), biasing the Cox model. The person-days calculated for the composite progression endpoint drastically differ between groups (approx 28,100 for azvudine vs 22,700 for control) despite starting with identical sample sizes and following a 30-day max horizon. This suggests control patients were systematically censored earlier, creating a survival bias in the time-to-event analysis. Authors also acknowledge that the composite disease progression finding was not robust across sensitivity analyses.
The mortality result should have higher reliability, with consistent results across all five sensitivity analyses - probabilistic PSM, mean imputation, excluding first-day discharges, doubly robust estimation, and IPTW. However, differential censoring likely affects the results here as well. The raw counts in the PSM groups shows a more modest ~15% benefit.
In Table 3, the reported percentages do not match the counts. For example, serum phosphorus in the control group reports 74 cases out of 2223 (which is 3.3%) but shows 23%. Table 3 reports 70 Grade >= 3 events for hypertriglyceridemia in the control group and 100 in the azvudine group, however these are much larger than the number of events for all grades. Table 3 lists available data for hypertriglyceridemia as control = 2465 and azvudine = 2454. These numbers exceed the post-matching cohort size of 2434 patients per group.
The text states the mortality rate in the control group was 8.79% (n = 214), but later claims there were 216 cases.
4 preclinical studies support the efficacy of azvudine for COVID-19:
Standard of Care (SOC) for COVID-19 in the study country,
China, is average with moderate efficacy for approved treatments5.
This study is excluded in the after exclusion results of meta-analysis:
potential significant differential censoring.
|
risk of death, 36.0% lower, HR 0.64, p < 0.001, treatment 2,434, control 2,434, propensity score matching.
|
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risk of progression, 16.0% lower, HR 0.84, p = 0.03, treatment 2,434, control 2,434, propensity score matching.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
1.
Xiong et al., Real-world data of Azvudine-induced hepatotoxicity among hospitalized COVID-19 patients in China: a retrospective case-control study, Frontiers in Pharmacology, doi:10.3389/fphar.2025.1558054.
2.
Wang et al., Development and validation of a nomogram to assess the occurrence of liver dysfunction in patients with COVID-19 pneumonia in the ICU, BMC Infectious Diseases, doi:10.1186/s12879-025-10684-1.
3.
Li et al., Azvudine alleviates SARS-CoV-2-induced inflammation by targeting myeloperoxidase in NETosis, Chinese Chemical Letters, doi:10.1016/j.cclet.2024.110238.
Chen et al., 26 Feb 2026, retrospective, China, peer-reviewed, 15 authors, study period December 2022 - January 2023, trial NCT06349655 (history).
Contact: 20390@sias.edu.cn.
Evaluating the effectiveness and safety of Azvudine for hospitalised patients with COVID-19 and hypertension: a multicenter retrospective cohort study
Scientific Reports, doi:10.1038/s41598-025-34514-1
Hypertension is widely acknowledged as a major risk factor for disease severity and death in patients with coronavirus disease 2019 (COVID-19). Azvudine is recommended for COVID-19 patients in China. However, its clinical efficacy and safety for individuals with hypertension remain unclear. This nine-center retrospective cohort study included 32864 hospitalized COVID-19 patients in Henan Province, China, from December 2022 to January 2023. Among these patients, those with hypertension were identified and divided into the Azvudine and control groups (standard treatment without antiviral medication) after propensity score matching (PSM) at a 1:1 ratio. The primary outcomes measured were all-cause mortality and composite disease progression. Subgroup analyses and sensitivity tests were conducted to verify the robustness of the results. Safety was assessed based on adverse events (AEs). After PSM to balance baseline characteristics, the analysis included 2,434 Azvudine recipients and 2,434 controls, forming a final matched cohort. Azvudine was associated with a lower risk of all-cause mortality (HR: 0.64, 95% CI: 0.519-0.780; P < 0.001) and composite disease progression (HR: 0.84, 95% CI: 0.719-0.985; P = 0.032) in hypertensive patients with COVID-19. In five sensitivity analyses, Azvudine showed a highly robust effect in reducing allcause mortality, while the evidence for a reduction in the progression of composite disease progression was less consistent. No significant difference in severe AEs (≥ Grade 3) was observed between groups. These real-world findings suggest Azvudine may be a promising antiviral option for hypertensive COVID-19 patients, but further prospective trials are necessary to confirm these results.
References
Bernal, Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients, The New England journal of medicine, doi:10.1056/NEJMoa2116044
Cascella, Rajnik, Aleem, Dulebohn, Napoli, None
Hammond, Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19, The New England journal of medicine, doi:10.1056/NEJMoa2118542
Hayden, The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023), Clin Infect Dis, doi:10.1093/cid/ciad032
Who, WHO COVID-19 dashboard. Coronavirus biology and replication: implications for SARS-CoV-2, Nat Rev Microbiol, doi:10.1038/s41579-020-00468-6
Yu, Chang, The first Chinese oral anti-COVID-19 drug Azvudine launched, Innovation, doi:10.1016/j.xinn.2022.100321
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Late treatment
is less effective
is less effective
