c19early.org COVID-19 treatment researchCOVID-19 treatments

Real-world effectiveness of Azvudine in hospitalized patients with COVID-19: a retrospective cohort study

Shen et al., medRxiv, doi:10.1101/2023.01.23.23284899, Jan 2023
Late treatmentPSM retrospective · 452 patients · China
Azvudine for COVID-19
Shen et al. medRxiv · January 2023
Outcome
Improvement
Relative Risk · 95% CI
Mortality
74%0.26 · 0.07–0.94
Ventilation
91%0.09 · 0.01–1.63
ICU admission
75%0.25 · 0.03–2.22
Progression
57%0.43 · 0.18–0.99
00.511.52+
← Azvudine
reduces riskAzvudine
increases risk →
Lower mortality and progression with azvudine
p = 0.04 (mortality) and p = 0.048 (progression)

Azvudine for COVID-19

48th treatment shown to reduce risk in January 2023, now with p = 0.0000000021 from 42 studies.
Lower risk for mortality, ICU, hospitalization, progression, and viral clearance.

No treatment is 100% effective.
Protocols combine treatments.

6,700+ studies · 220+ treatments

c19early.org
Meta-analysis
PSM retrospective 900 hospitalized COVID-19 patients in China showing lower risk of disease progression and death with azvudine treatment.
Liver injury. Studies show significantly increased risk of liver injury1,2.
Standard of Care (SOC) for COVID-19 in the study country, China, is average with moderate efficacy for approved treatments3.
Important missing comments or errors? Let us know.
OutcomeImprovementEffect · pTreatmentControl
risk of death 74.0% lower · HR 0.26 · p = 0.04* 74.0% lowerHR 0.26p = 0.04* 3 of 226 (1.3%) 10 of 226 (4.4%) treatment 3 of 226 (1.3%), control 10 of 226 (4.4%)NNT 32propensity score matchingCox proportional hazards
risk of mechanical ventilation 90.9% lower · RR 0.09 · p = 0.06 90.9% lowerRR 0.09p = 0.06 0 of 226 (0.0%) 5 of 226 (2.2%) treatment 0 of 226 (0.0%), control 5 of 226 (2.2%)NNT 45propensity score matchingcontinuity correction due to zero events
risk of ICU admission 75.0% lower · RR 0.25 · p = 0.37 75.0% lowerRR 0.25p = 0.37 1 of 226 (0.4%) 4 of 226 (1.8%) treatment 1 of 226 (0.4%), control 4 of 226 (1.8%)NNT 75propensity score matching
risk of progression 57.0% lower · HR 0.43 · p = 0.05* 57.0% lowerHR 0.43p = 0.05* 8 of 226 (3.5%) 17 of 226 (7.5%) treatment 8 of 226 (3.5%), control 17 of 226 (7.5%)all-cause death, intensive care unit admission, initiation of invasive mechanical ventilation, and need for high-flow oxygen therapyNNT 25propensity score matchingCox proportional hazards

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates. * p < 0.05

Shen et al., 23 Jan 2023, retrospective, China, preprint, 12 authors, average treatment delay 8.2 days. Contact: dengguangtong@outlook.com, chenxiangck@126.com, shenmx1988@csu.edu.cn, zengflorachn@hotmail.com.
$0 $500 $1,000+ Efficacy vs. cost for COVID-19 treatment protocols c19early.org November 2026 China Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan Nepal Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Bosnia-Herzegovina Dominican Republic Bolivia Côte d'Ivoire Eritrea Togo Bulgaria Greece Slovakia Iceland New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel Haiti North Macedonia Hong Kong Qatar Panama Serbia Benin Burundi Cameroon CAR China favored low-cost treatments.The average efficacy of treatments was moderate.Low-cost treatments improve early treatment, andprovide complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
$0 $500 $1,000+ Efficacy vs. cost for COVID-19treatment protocols worldwide c19early.org November 2026 China Angola Colombia Kenya Mozambique Myanmar South Africa Peru Philippines USA Brazil France Italy Canada Pakistan Spain Vietnam Japan Iran Bangladesh Ethiopia Ghana Germany Mexico South Korea United Kingdom Saudi Arabia Algeria Morocco Yemen Poland Thailand Uganda Egypt Nigeria Taiwan Fiji Zambia Dominican Rep. Bolivia Côte d'Ivoire Eritrea Togo Sri Lanka Bulgaria Greece Slovakia New Zealand Trinidad and Tobago Mongolia Czechia Belarus Israel North Macedonia Hong Kong Qatar Panama Serbia Benin Burundi CAR Syria China favored low-cost treatments.The average efficacy was moderate.Low-cost protocols improve early treatment,and add complementary/synergistic benefits. More effective More expensive 75% 50% 25% ≤0%
Real-world effectiveness of Azvudine in hospitalized patients with COVID-19: a retrospective cohort study
Minxue Shen, Chenggen Xiao, Yuming Sun, Daishi Li, Ping Wu, Liping Jin, Qingrong Wu, Yating Dian, Yu Meng, Furong Zeng, Xiang Chen, Guangtong Deng
doi:10.1101/2023.01.23.23284899
Current guidelines prioritize the use of the Azvudine in coronavirus disease 2019 (COVID-19) patients. However, the clinical effectiveness of Azvudine in real-world studies was lacking, despite the clinical trials showed shorter time of nucleic acid negative conversion. To evaluate the clinical effectiveness following Azvudine treatment in hospitalized COVID-19 patients, we identified 1505 hospitalized COVID-19 patients during the study period, with a follow-up of up to 29 days. After exclusions and propensity score matching, we included 226 Azvudine recipients and 226 matched controls. The lower crude incidence rate of composite disease progression outcome (4.21 vs. 10.39 per 1000 person-days, P=0.041) and all-cause mortality (1.57 vs. 6.00 per 1000 person-days, P=0.027) were observed among Azvudine recipients compared with matched controls. The incidence rates of initiation of invasive mechanical ventilation were also statistically different between the groups according to the log-rank tests (P=0.020). Azvudine treatment was associated with significantly lower risks of composite disease progression outcome (hazard ratio [HR]: 0.43; 95% confidence interval [CI]: 0.18 to 0.99) and all-cause death (HR: 0.26; 95% CI: 0.07 to 0.94) compared with matched controls. Subgroup analyses indicated robustness of the point estimates of HRs (ranged from 0.14 to 0.84). Notably, male Azvudine recipients had a stronger effectiveness than female recipients with respect to both composite outcome and all-cause death. These findings suggest that Azvudine treatment showed substantial clinical benefits in hospitalized COVID-19 patients, and should be considered for use in this population of patients.
CONFLICT OF INTERESTS The authors declare no conflicts of interest that pertain to this work. CONTRIBUTIONS Conception and design: Guangtong, Xiang Chen, Furong Zeng, and Minxue Shen. Acquisition of data: Furong Zeng, Chenggen Xiao, Yuming Sun, Daishi Li, Ping Wu. Interpretation of data, statistical analysis and manuscript writing: Guangtong Deng, Furong Zeng, and Minxue Shen.
References
Amani, Amani, Efficacy and safety of nirmatrelvir/ritonavir (Paxlovid) for COVID-19 : a rapid review and meta-analysis, J Med Virol, doi:10.1002/jmv.28441
Austin, Some methods of propensity-score matching had superior performance to others: results of an empirical investigation and Monte Carlo simulations, Biom J, doi:10.1002/bimj.200810488
Chang, 4'-Modified Nucleosides for Antiviral Drug Discovery: Achievements and Perspectives, Acc Chem Res, doi:10.1021/acs.accounts.1c00697
Cheema, Nirmatrelvir-ritonavir for the treatment of COVID-19 patients: a systematic review and meta-analysis, J Med Virol, doi:10.1002/jmv.28471
Lieber, SARS-CoV-2 VOC type and biological sex affect molnupiravir efficacy in severe COVID-19 dwarf hamster model, Nat Commun, doi:10.1038/s41467-022-32045-1
Murakami, Therapeutic advances in COVID-19, Nat Rev Nephrol, doi:10.1038/s41581-022-00642-4
Ren, A Randomized, Open-Label, Controlled Clinical Trial of Azvudine Tablets in the Treatment of Mild and Common COVID-19, a Pilot Study, Adv Sci (Weinh), doi:10.1002/advs.202001435
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Zhang, Azvudine is a thymus-homing anti-SARS-CoV-2 drug effective in treating COVID-19 patients, Signal Transduct Target Ther, doi:10.1038/s41392-021-00835-6
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Late treatment
is less effective