Summary of COVID-19 azvudine studies

1. de Souza et al., Phase III, randomized, double-blind, placebo-controlled clinical study: a study on the safety and clinical efficacy of AZVUDINE in moderate COVID-19 patients

179 patient azvudine late treatment RCT: 82% improved recovery (p=0.01) and 13% faster viral clearance (p=0.03).
RCT 179 hospitalized patients in Brazil, showing improved recovery with azvudine treatment.
Oct 2023, Frontiers in Medicine, https://www.frontiersin.org/articles/10.3389/fmed.2023.1215916/full, https://c19p.org/desouza2

2. Xu et al., Systematic evaluation of therapeutic effectiveness of Azvudine in treating COVID-19 hospitalized patients: a retrospective cohort study

264 patient azvudine late treatment PSM study: 75% lower mortality (p=0.02) and 63% lower progression (p=0.02).
Retrospective 264 hospitalized COVID-19 patients in China showing lower risk of composite disease progression and all-cause mortality with azvudine treatment.
Nov 2024, Frontiers in Cellular and Infection Microbiology, https://www.frontiersin.org/articles/10.3389/fcimb.2024.1453234/full, https://c19p.org/xu17

3. Shen et al., Real-world effectiveness of Azvudine in hospitalized patients with COVID-19: a retrospective cohort study

452 patient azvudine late treatment PSM study: 74% lower mortality (p=0.04), 91% lower ventilation (p=0.06), 75% lower ICU admission (p=0.37), and 57% lower progression (p=0.05).
PSM retrospective 900 hospitalized COVID-19 patients in China showing lower risk of disease progression and death with azvudine treatment.
Jan 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.01.23.23284899, https://c19p.org/shen3

4. Zhang et al., Efficacy of azvudine plus dexamethasone in severe hospitalized patients with Omicron infection: a prospective multicenter study

209 patient azvudine late treatment study: 43% lower progression (p=0.03) and 14% faster viral clearance (p=0.02).
Prospective multicenter study of 209 severe hospitalized COVID-19 patients in China showing improved 28-day composite outcomes, faster viral clearance, and higher PaO2/FiO2 levels with azvudine plus dexamethasone compared to dexamethasone alone.
Nov 2024, Frontiers in Cellular and Infection Microbiology, https://www.frontiersin.org/articles/10.3389/fcimb.2024.1390098/full, https://c19p.org/zhang39

5. Wu et al., Azvudine for the Treatment of COVID‐19 in Pre‐Existing Cardiovascular Diseases: A Single‐Center, Real‐World Experience

351 patient azvudine early treatment PSM study: 81% lower mortality (p=0.0008).
Retrospective 351 hospitalized COVID-19 patients with pre-existing cardiovascular diseases in China, showing lower mortality with azvudine treatment.
Mar 2024, Advanced Science, https://onlinelibrary.wiley.com/doi/10.1002/advs.202306050, https://c19p.org/wu10

6. Zong et al., Azvudine reduces the in-hospital mortality of COVID-19 patients: A retrospective cohort study

1,072 patient azvudine late treatment PSM study: 62% lower mortality (p=0.0002).
PSM retrospective 1072 hospitalized patients with COVID-19 pneumonia in China, showing lower mortality with azvudine treatment.
Jul 2023, Acta Pharmaceutica Sinica B, https://www.sciencedirect.com/science/article/pii/S2211383523002575, https://c19p.org/zong

7. Yang et al., Oral azvudine for mild‐to‐moderate COVID‐19 in high risk, nonhospitalized adults: Results of a real‐world study

804 patient azvudine early treatment study: 91% lower mortality (p=0.09), 75% lower hospitalization (p=0.05), and 16% improved recovery (p=0.19).
PSM retrospective 804 high-risk, nonhospitalized adults with mild to moderate COVID-19 in China. The study compared outcomes between 317 patients who received azvudine with 487 patients who received standard supportive treatment only. The azvudine group had a lower rate of disease progression (composite of death or COVID-19 hospitalization) at 28 days, as well as a lower rate of COVID-19 hospitalization specifically after adjusting for factors. In addition, azvudine shortened the duration of fever if given within 3 days of symptom onset. However, azvudine treatment was associated with a higher incidence of adverse effects, including mainly mild gastrointestinal and nervous system effects.
Jul 2023, J. Medical Virology, https://onlinelibrary.wiley.com/doi/10.1002/jmv.28947, https://c19p.org/yang8

8. Zhu et al., Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study

3,998 patient azvudine late treatment PSM study: 22% lower mortality (p=0.001), 13% higher hospital discharge (p=0.05), 1% shorter hospitalization (p=0.43), and 10% faster viral clearance (p<0.0001).
PSM retrospective 3,998 hospitalized COVID-19 patients aged 60 years and older in China showing lower all-cause mortality, higher rate of discharge, and shorter time to viral clearance with azvudine treatment.
Dec 2024, Acta Pharmaceutica Sinica B, https://www.sciencedirect.com/science/article/pii/S2211383524004611, https://c19p.org/zhu9

9. Ren et al., Real-world effectiveness and safety of Azvudine in hospitalized patients with SARS-CoV-2 infection: a multicenter, retrospective cohort study

32,864 patient azvudine late treatment PSM study: 32% lower mortality (p<0.0001) and 12% lower progression (p=0.01).
PSM retrospective 32,864 hospitalized COVID-19 patients in China showing lower all-cause mortality and disease progression with azvudine treatment.
Nov 2024, J. Infection, https://www.sciencedirect.com/science/article/pii/S0163445324002901, https://c19p.org/ren2

10. Shao et al., Composite Interventions on Outcomes of Severely and Critically Ill Patients with COVID-19 in Shanghai, China

686 patient azvudine late treatment study: 56% lower mortality (p=0.007).
Retrospective 1,082 severely and critically ill COVID-19 patients in China showing lower 60 day mortality with azvudine. Mortality was also lower with paxlovid, but without statistical significance, and health related quality of life was significantly lower for paxlovid patients at 60 days.
Jul 2023, Microorganisms, https://www.mdpi.com/2076-2607/11/7/1859, https://c19p.org/shao4azv

11. Li et al., A Retrospective Analysis of Azvudine in Patients with COVID-19 and Pre-existing Cancer

84 patient azvudine late treatment study: 11% shorter hospitalization (p=0.26) and 50% improved viral clearance (p=0.03).
PSM retrospective 84 hospitalized COVID-19 patients with pre-existing cancer in China, showing faster viral clearance with azvudine. There was no significant difference in length of hospital stay or ICU admission.
Mar 2024, J. Cancer, https://www.jcancer.org/v15p2442, https://c19p.org/li29

12. Han et al., Effectiveness and Optimal Timing of Azvudine in COVID-19 Patients: A Multi-center Retrospective Study in Beijing, China

856 patient azvudine early treatment PSM study: 37% lower mortality (p=0.05) and 3% greater improvement (p=0.73).
PSM retrospective 6,218 hospitalized COVID-19 patients in China showing lower 28-day all-cause mortality with azvudine treatment compared to controls (HR 0.63, 95% CI 0.40-1.00). Subgroup analysis found significantly faster clinical improvement when azvudine was initiated within 5 days of symptom onset compared to controls.
Jul 2023, Research Square, https://www.researchsquare.com/article/rs-3145554/v1, https://c19p.org/han

13. Sun et al., Oral Azvudine for hospitalised patients with COVID-19 and pre-existing conditions: a retrospective cohort study

490 patient azvudine late treatment study: 54% lower mortality (p=0.16), 38% lower need for oxygen therapy (p=0.15), and 48% lower progression (p=0.02).
PSM retrospective 490 hospitalized COVID-19 patients with pre-existing conditions in China showing that azvudine was associated with a significantly lower risk of the composite outcome of disease progression, driven largely by lower rates of non-invasive respiratory support. However, there was no significant difference in all-cause mortality or other individual outcomes like ICU admission or invasive mechanical ventilation between the azvudine and control groups.
May 2023, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S258953702300158X, https://c19p.org/sun4

14. Zhong et al., Azvudine reduces the mortality rate of patients with Coronavirus disease 2019: a single-center retrospective analysis study

2,863 patient azvudine late treatment study: 35% lower mortality (p=0.05).
Retrospective 2,862 hospitalized COVID-19 patients in China showing lower mortality with azvudine treatment.
Mar 2024, Research Square, https://www.researchsquare.com/article/rs-4157424/v1, https://c19p.org/zhong6

15. Li et al., Risk of severe case in COVID-19 patients and Azvudine: A Retrospective cohort study after exit from ‘zero-COVID’ policy

2,206 patient azvudine late treatment PSM study: 29% lower mortality (p=0.03).
Retrospective 4,201 hospitalized COVID-19 patients in China, showing lower mortality with azvudine.
Jan 2024, Research Square, https://www.researchsquare.com/article/rs-3707560/v1, https://c19p.org/li28

16. Dian et al., Azvudine versus Paxlovid for oral treatment of COVID-19 in Chinese patients with pre-existing comorbidities

2,118 patient azvudine late treatment PSM study: 64% lower mortality (p=0.11), 67% lower ventilation (p=0.28), and 48% lower progression (p=0.03).
Retrospective 2,118 hospitalized COVID-19 patients in China, showing improved results with azvudine vs. paxlovid.
Aug 2023, J. Infection, https://www.sciencedirect.com/science/article/pii/S0163445323002906, https://c19p.org/dian

17. Liu et al., Effectiveness of Azvudine and Nirmatrelvir-ritonavir in Kidney Transplant Recipients With COVID-19: A Retrospective Cohort Study

148 patient azvudine late treatment PSM study: 45% lower progression (p=0.36).
Retrospective 148 hospitalized kidney transplant patients with COVID-19 in China showing lower risk of disease progression with azvudine treatment compared, and higher risk with paxlovid treatment.
Apr 2024, Infections in the immunosuppressed and immunocompromised host, https://www.atsjournals.org/doi/10.1164/ajrccm-conference.2024.209.1_MeetingAbstracts.A2917, https://c19p.org/liu23

18. Wang et al., Antiviral effectiveness and survival correlation of azvudine and nirmatrelvir/ritonavir in elderly severe patients with COVID-19: a retrospective real-world study

249 patient azvudine early treatment study: 20% lower mortality (p=0.44) and 3% lower progression (p=0.91).
Retrospective 249 elderly patients with severe COVID-19, 128 treated with azvudine, 66 treated with paxlovid, and 55 receiving neither treatment, showing no significant differences for Ct value changes, progression, or survival for either treatment. Early viral decline was faster with paxlovid, without statistical significance.
Feb 2024, eClinicalMedicine, https://www.sciencedirect.com/science/article/pii/S2589537024000476, https://c19p.org/wang25

19. Liu et al., Clinical characteristics, outcomes, and risk factors of SARS-CoV-2 breakthrough infections among 572 fully vaccinated (BBIBP-CorV) hospitalized patients

572 patient azvudine late treatment study: 24% lower progression (p=0.44).
Retrospective 572 fully vaccinated hospitalized patients in China, showing lower risk with azvudine treatment, without statistical significance. The composite outcome included intubation, non-invasive respiratory support, ICU admission, and all-cause death. Azvudine was not included in the multivariable analysis (only combined antiviral therapy was used without explanation).
Oct 2023, Heliyon, https://www.sciencedirect.com/science/article/pii/S240584402308595X, https://c19p.org/liu13azv

20. Wei et al., Head-to-head comparison of azvudine and nirmatrelvir/ritonavir for the hospitalized patients with COVID-19: a real-world retrospective cohort study with propensity score matching

725 patient azvudine late treatment study: no change in mortality (p=1), 28% lower ventilation (p=0.04), 55% lower ICU admission (p=0.05), and 22% lower progression (p=0.07).
PSM retrospective 725 hospitalized COVID-19 patients in China compared the effectiveness and safety of the oral antivirals azvudine and paxlovid. There was no significant difference in the risk of disease progression between groups, but azvudine was associated with lower ICU admission and invasive ventilation use.
Oct 2023, Frontiers in Pharmacology, https://www.frontiersin.org/articles/10.3389/fphar.2023.1274294/full, https://c19p.org/wei2

21. Zhou et al., Secondary pulmonary infection and co-infection in elderly COVID-19 patients during the pandemics in a tertiary general hospital in Beijing, China

322 patient azvudine late treatment study: 22% lower mortality (p=0.15).
Retrospective 322 hospitalized patients ≥65 in China, showing lower mortality with azvudine treatment, without statistical significance.
Oct 2023, Frontiers in Microbiology, https://www.frontiersin.org/articles/10.3389/fmicb.2023.1280026/full, https://c19p.org/zhou13azv

22. Chen et al., Oral Azvudine (FNC) Tablets in Patients infected with SARS-CoV-2 Omicron Variant: A Retrospective Cohort Study

207 patient azvudine early treatment study: 12% slower recovery (p=0.95) and 32% improved viral clearance (p=0.04).
Retrospective 207 COVID-19 patients in China, showing azvudine associated with faster viral clearance, with azvudine-treated patients obtaining a negative PCR test result 1.7 days faster on average compared to supportive care alone after adjusting for age and sex.
Jan 2023, medRxiv, https://www.medrxiv.org/content/10.1101/2023.01.05.23284180, https://c19p.org/chen13

23. Chen et al., All-cause mortality in moderate and severe COVID-19 patients with myocardial injury receiving versus not receiving azvudine: a propensity score-matched analysis

198 patient azvudine late treatment PSM study: 6% lower mortality (p=0.88).
PSM retrospective 332 hospitalized moderate to critically ill COVID-19 patients with myocardial injury in China, showing improved 14 day mortality but no difference in overall in-hospital mortality with azvudine treatment.
Apr 2023, Cardiology Plus, https://journals.lww.com/10.1097/CP9.0000000000000049, https://c19p.org/chen16

24. Peng et al., Impact of Anti-angiogenic Drugs on Severity of COVID-19 in Patients with Non-Small Cell Lung Cancer

166 patient azvudine late treatment study: 13% higher mortality (p=0.85).
Retrospective 166 hospitalized NSCLC patients with COVID-19 showing no significant difference in mortality with paxlovid or azvudine in univariate analysis.
Jan 2024, Technology in Cancer Research & Treatment, https://journals.sagepub.com/doi/10.1177/15330338241248573, https://c19p.org/peng4azv

25. Lv et al., Clinical characteristics and outcomes of hospitalized kidney transplant recipients with COVID-19 infection in China during the Omicron wave: a single-center cohort study

324 patient azvudine late treatment study: 42% higher mortality (p=0.64).
Retrospective 324 hospitalized kidney transplant recipients with COVID-19 showing no significant benefit with molnupiravir, paxlovid, or azvudine. The study was conducted during the omicron wave in China between December 2022 and January 2023. Adjusted results are only provided for all antivirals combined, however the results are similar before and after adjustment. Multivariable Cox regression analysis for all antivirals combined showed an adjusted hazard ratio for mortality of 6.06, p=0.099. While adjustment includes factors related to baseline severity, there may be residual confounding by indication.
Jun 2024, J. Zhejiang University - SCIENCE B (Biomedicine & Biotechnology, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11199089/, https://c19p.org/lv3azv

26. Jin et al., Effects of Azvudine on the Low-Risk Patients Infected with COVID-19 Omicron Variants: A Retrospective Case-Control Study

481 patient azvudine early treatment study: 1% slower recovery (p=0.9).
Retrospective 481 low-risk COVID-19 patients in China showing no significant difference in recovery or symptomatic severity with azvudine, but slightly lower total viral load.
Feb 2024, J. Clinical Pharmacology and Therapeutics, https://www.medtextpublications.com/open-access/effects-of-azvudine-on-the-low-risk-patients-infected-with-covid-19-1584.pdf, https://c19p.org/jin

27. Zhang et al., Efficacy of Azvudine Therapy in Patients with Severe and Non-Severe COVID‐19: A Propensity Score-Matched Analysis

606 patient azvudine late treatment study: 32% higher mortality (p=0.2), 62% higher ventilation (p=0.22), 7% higher ICU admission (p=0.89), and 9% shorter hospitalization (p=0.05).
PSM retrospective 303 hospitalized patients treated with azvudine and 303 matched controls in China, showing shorter hospital stay and higher lymphocyte improvement rate, particularly for non-severe patients, however there were no significant differences for mortality, ICU admission, or mechanical ventilation.
Oct 2024, Infection and Drug Resistance, https://www.dovepress.com/efficacy-of-azvudine-therapy-in-patients-with-severe-and-non-severe-co-peer-reviewed-fulltext-article-IDR, https://c19p.org/zhang35

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