Effectiveness and safety of azvudine in the treatment of COVID-19 patients: a retrospective cohort study using propensity score matching

DOI record: { "DOI": "10.3389/fcimb.2025.1584261", "ISSN": [ "2235-2988" ], "URL": "http://dx.doi.org/10.3389/fcimb.2025.1584261", "abstract": "<jats:sec><jats:title>Background</jats:title><jats:p>Clinical trials have demonstrated the efficacy of azvudine in alleviating clinical symptoms among patients with coronavirus disease 2019 (COVID-19). However, evidence regarding its real-world effectiveness and safety profile remains limited.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To evaluate the effectiveness and safety of azvudine in COVID-19 patients.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This retrospective cohort study included 192 COVID-19 patients hospitalized in Fengtai District, Beijing, from November 1 to December 31, 2022. Patients were divided into azvudine (n=118) and non-azvudine (n=74) groups. Propensity score matching (PSM) was applied to balance baseline characteristics (age, sex, vaccination status, etc.), yielding 48 matched pairs. Outcomes included time to SARS-CoV-2 RNA negativity, hospitalization duration, and symptom resolution (fever, cough). Adverse events were recorded.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>After PSM, 48 pairs of COVID-19 patients were identified. The azvudine group exhibited significantly shorter hospitalization than the non-azvudine group (median: 8 vs. 10 days, <jats:italic>P ≤</jats:italic> 0.05). No significant differences were observed in time to RNA negativity (4.23 vs. 4.52 days, <jats:italic>P</jats:italic>&amp;gt;0.05), fever duration (2 vs. 2 days, <jats:italic>P</jats:italic>&amp;gt;0.05), or cough duration (4.5 vs. 5 days, <jats:italic>P</jats:italic>&amp;gt;0.05). One case of mild gastrointestinal discomfort was reported in the azvudine group.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Azvudine significantly reduced hospitalization duration in mild-to-moderate COVID-19 patients with a favorable safety profile.</jats:p></jats:sec>", "alternative-id": [ "10.3389/fcimb.2025.1584261" ], "author": [ { "affiliation": [], "family": "Zhang", "given": "Jing", "sequence": "first" }, { "affiliation": [], "family": "Wang", "given": "Fang", "sequence": "additional" }, { "affiliation": [], "family": "Xie", "given": "Ying", "sequence": "additional" }, { "affiliation": [], "family": "Li", "given": "Qianyu", "sequence": "additional" }, { "affiliation": [], "family": "Zhu", "given": "Zhenzhen", "sequence": "additional" }, { "affiliation": [], "family": "Dong", "given": "Yuan", "sequence": "additional" } ], "container-title": "Frontiers in Cellular and Infection Microbiology", "container-title-short": "Front. Cell. Infect. Microbiol.", "content-domain": { "crossmark-restriction": true, "domain": [ "frontiersin.org" ] }, "created": { "date-parts": [ [ 2025, 6, 18 ] ], "date-time": "2025-06-18T05:41:50Z", "timestamp": 1750225310000 }, "deposited": { "date-parts": [ [ 2025, 6, 18 ] ], "date-time": "2025-06-18T05:41:53Z", "timestamp": 1750225313000 }, "indexed": { "date-parts": [ [ 2025, 6, 19 ] ], "date-time": "2025-06-19T04:13:56Z", "timestamp": 1750306436095, "version": "3.41.0" }, "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2025, 6, 18 ] ] }, "license": [ { "URL": "https://creativecommons.org/licenses/by/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2025, 6, 18 ] ], "date-time": "2025-06-18T00:00:00Z", "timestamp": 1750204800000 } } ], "link": [ { "URL": "https://www.frontiersin.org/articles/10.3389/fcimb.2025.1584261/full", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "1965", "original-title": [], "prefix": "10.3389", "published": { "date-parts": [ [ 2025, 6, 18 ] ] }, "published-online": { "date-parts": [ [ 2025, 6, 18 ] ] }, "publisher": "Frontiers Media SA", "reference": [ { "DOI": "10.3390/v15071515", "article-title": "Effectiveness of oral nirmatrelvir/ritonavir vs. Intravenous three-day remdesivir in preventing progression to severe COVID-19: A single-center, prospective, comparative, real-life study", "author": "Basoulis", "doi-asserted-by": "publisher", "journal-title": "Viruses.", "key": "B1", "volume": "15", "year": "2023" }, { "DOI": "10.1016/j.heliyon.2023.e20153", "article-title": "Efficacy and safety of azvudine in patients with COVID-19: A systematic review and meta-analysis", "author": "Chen", "doi-asserted-by": "publisher", "journal-title": "Heliyon", "key": "B2", "volume": "9", "year": "2023" }, { "key": "B3", "unstructured": "Circular on the issuance of a protocol for the diagnosis and treatment of novel coronavirus infections (Trial 10th edition)\n \n 2023" }, { "DOI": "10.1016/j.jinf.2023.03.023", "article-title": "Antiviral effect of azvudine and nirmatrelvir-ritonavir among hospitalized patients with COVID-19", "author": "Gao", "doi-asserted-by": "publisher", "first-page": "e158", "journal-title": "J. Infect.", "key": "B4", "volume": "86", "year": "2023" }, { "DOI": "10.19803/j.1672-8629.20230357", "article-title": "The latest progress of small molecule anti-SARS-CoV-2 drugs", "author": "Ma", "doi-asserted-by": "publisher", "first-page": "961", "journal-title": "Chin. J. Pharmacovigilance", "key": "B5", "volume": "20", "year": "2023" }, { "DOI": "10.1126/science.abi5224", "article-title": "Fe-S cofactors in the SARS-CoV-2 RNA-dependent RNA polymerase are potential antiviral targets", "author": "Maio", "doi-asserted-by": "publisher", "first-page": "236", "journal-title": "Science.", "key": "B6", "volume": "373", "year": "2021" }, { "DOI": "10.1002/jmv.28660", "article-title": "Risk of hospitalization and sequelae in patients with COVID-19 treated with 3-day early remdesivir vs. controls in the vaccine and Omicron era: A real-life cohort study", "author": "Mazzitelli", "doi-asserted-by": "publisher", "journal-title": "J. Med. Virol.", "key": "B7", "volume": "95", "year": "2023" }, { "DOI": "10.1021/jm801595c", "article-title": "The design, synthesis, and antiviral activity of monofluoro and difluoro analogues of 4’-azidocytidine against hepatitis C virus replication: the discovery of 4’-azido-2’-deoxy-2’-fluorocytidine and 4’-azido-2’-dideoxy-2’,2’-difluorocytidine", "author": "Smith", "doi-asserted-by": "publisher", "first-page": "2971", "journal-title": "J. Med. Chem.", "key": "B8", "volume": "52", "year": "2009" }, { "DOI": "10.1002/jmv.26264", "article-title": "RNA-dependent RNA polymerase of SARS-CoV-2 as a therapeutic target", "author": "Wang", "doi-asserted-by": "publisher", "first-page": "300", "journal-title": "J. Med. Virol.", "key": "B9", "volume": "93", "year": "2021" }, { "DOI": "10.3389/fphar.2023.1274294", "article-title": "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", "author": "Wei", "doi-asserted-by": "publisher", "journal-title": "Front. Pharmacol.", "key": "B10", "volume": "14", "year": "2023" }, { "DOI": "10.1128/JVI.00204-20", "article-title": "The pyrimidine analog FNC potently inhibits the replication of multiple enteroviruses", "author": "Xu", "doi-asserted-by": "publisher", "first-page": "e00204", "journal-title": "J. Virol.", "key": "B11", "volume": "94", "year": "2020" }, { "DOI": "10.1016/j.xinn.2022.100321", "article-title": "The first Chinese oral anti-COVID-19 drug Azvudine launched", "author": "Yu", "doi-asserted-by": "publisher", "journal-title": "Innovation (Camb).", "key": "B12", "volume": "3", "year": "2022" }, { "DOI": "10.13412/j.cnki.zyyl.20220608.004", "article-title": "Efficacy of jinyebaidu granule and lianhuaqingwen capsule in the treatment of severe COVID-19 patients:A retrospective cohort study adjusted with propensity score matching", "author": "Yu", "doi-asserted-by": "publisher", "first-page": "66", "journal-title": "Pharmacol. Clinics Chin. Materia Med.", "key": "B13", "volume": "39", "year": "2023" }, { "DOI": "10.3389/fimmu.2023.1125246", "article-title": "The development of COVID-19 treatment", "author": "Yuan", "doi-asserted-by": "publisher", "journal-title": "Front. Immunol.", "key": "B14", "volume": "14", "year": "2023" }, { "article-title": "Clinical effectiveness evaluation of Azvudine in mild and moderate high-risk patients with COVID-19 infection", "author": "Zhang", "journal-title": "Chin. J. Hosp. Pharm.", "key": "B15", "volume": "43", "year": "2023" }, { "DOI": "10.1038/s41392-021-00835-6", "article-title": "Azvudine is a thymus-homing anti-SARS-CoV-2 drug effective in treating COVID-19 patients", "author": "Zhang", "doi-asserted-by": "publisher", "first-page": "414", "journal-title": "Signal Transduct Target Ther.", "key": "B16", "volume": "6", "year": "2021" }, { "DOI": "10.3851/IMP2292", "article-title": "Novel nucleoside analogue FNC is effective against both wild-type and lamivudine-resistant HBV clinical isolates", "author": "Zhou", "doi-asserted-by": "publisher", "first-page": "1593", "journal-title": "Antivir Ther.", "key": "B17", "volume": "17", "year": "2012" }, { "DOI": "10.3389/fphar.2023.1228548", "article-title": "Efficacy and safety evaluation of Azvudine in the prospective treatment of COVID-19 based on four phase III clinical trials", "author": "Zhu", "doi-asserted-by": "publisher", "journal-title": "Front. Pharmacol.", "key": "B18", "volume": "14", "year": "2023" } ], "reference-count": 18, "references-count": 18, "relation": {}, "resource": { "primary": { "URL": "https://www.frontiersin.org/articles/10.3389/fcimb.2025.1584261/full" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "title": "Effectiveness and safety of azvudine in the treatment of COVID-19 patients: a retrospective cohort study using propensity score matching", "type": "journal-article", "update-policy": "https://doi.org/10.3389/crossmark-policy", "volume": "15" }