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Effectiveness and safety of azvudine in COVID-19: A systematic review and meta-analysis

Amani et al., PLOS ONE, doi:10.1371/journal.pone.0298772, PROSPERO CRD42023449248
Jun 2024  
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Mortality 52% Improvement Relative Risk Ventilation 10% ICU admission 31% Azvudine for COVID-19  Amani et al.  META ANALYSIS c19early.org Favorsazvudine Favorscontrol 0 0.5 1 1.5 2+
Azvudine for COVID-19
44th treatment shown to reduce risk in July 2023
 
*, now with p = 0.00022 from 20 studies.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
Meta analysis of 21 studies (7 studies have no control, comparing with paxlovid) with 10,011 COVID-19 patients showing lower mortality and faster viral clearance with azvudine treatment compared to standard of care or placebo, while there were no significant differences for length of hospitalization, ICU admission, or need for mechanical ventilation. Compared to paxlovid, azvudine was associated with lower mortality, ICU admission, and need for mechanical ventilation, while there were no significant differences in viral clearance or hospitalization time. Authors rated the certainty of evidence as low or moderate.
3 meta analyses show significant improvements with azvudine for mortality1-3, mechanical ventilation1, improvement1, and viral clearance1,3.
Currently there are 20 azvudine for COVID-19 studies, showing 32% lower mortality [18‑44%], 31% lower ventilation [7‑48%], 47% lower ICU admission [5‑70%], and 43% lower hospitalization [-85‑82%].
risk of death, 52.0% lower, RR 0.48, p < 0.001.
risk of mechanical ventilation, 9.7% lower, RR 0.90, p = 0.71.
risk of ICU admission, 31.3% lower, RR 0.69, p = 0.51.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Amani et al., 13 Jun 2024, peer-reviewed, 2 authors, trial PROSPERO CRD42023449248. Contact: b_amani@alumnus.tums.ac.ir.
This PaperAzvudineAll
Effectiveness and safety of azvudine in COVID-19: A systematic review and meta-analysis
Bahman Amani, Behnam Amani
PLOS ONE, doi:10.1371/journal.pone.0298772
Objective The aim of this study was to assess the effectiveness and safety of azvudine in treating coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). Methods A search was carried out in PubMed, Cochrane Library, Web of Science, medRxiv, and Google Scholar until October 20, 2023. The Cochrane risk of bias tools were used to assess the quality of included studies. Comprehensive Meta-Analysis software was used to analyze data. Results Twenty-one studies including 10,011 patients were examined. The meta-analysis results showed that azvudine and standard of care/placebo (SOC/PBO) were significantly different concerning mortality rate (risk ratio [RR] = 0.48, 95% confidence interval [CI]: 0.40 to 0.57) and negative polymerase chain reaction (PCR) conversion time (standard mean difference = -0.75, 95% CI: -1.29 to-0.21). However, the two groups did not show significant differences concerning hospital stay, intensive care unit (ICU) admission, and need for mechanical ventilation (P > 0.05). On the other hand, azvudine and nirmatrelvir-ritonavir were significantly different in mortality rate (RR = 0.73, 95% CI: 0.58 to 0.92), ICU admission (RR = 0.41, 95% CI: 0.21 to 0.78), and need for mechanical ventilation (RR = 0.67, 95% CI: 0.51 to 0.89), but the two treatments were not significantly different in negative PCR conversion time, and hospital stay (P > 0.05). The incidence of adverse events between groups was not significant (P > 0.05). The certainty of evidence was rated as low or moderate. Conclusions The antiviral effectiveness of azvudine against SARS-COV-2 is questionable with regard to the certainty of evidence. Further research should be conducted to establish the effectiveness and safety of azvudine in COVID-19.
Supporting information S1 Author Contributions Conceptualization: Bahman Amani, Behnam Amani. Formal analysis: Bahman Amani, Behnam Amani. Methodology: Bahman Amani, Behnam Amani. Project administration: Bahman Amani, Behnam Amani. Writing -original draft: Behnam Amani. Writing -review & editing: Bahman Amani, Behnam Amani.
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receiving azvudine: a propensity ' 'score-matched analysis', 'volume': '8', 'author': 'R Chen', 'year': '2023', 'journal-title': 'Cardiology plus'}, { 'key': 'pone.0298772.ref022', 'article-title': 'Efficacy and safety of azvudine in patients with COVID-19: A systematic ' 'review and meta-analysis', 'author': 'Z Chen', 'year': '2023', 'journal-title': 'Heliyon'}, { 'issue': '7', 'key': 'pone.0298772.ref023', 'doi-asserted-by': 'crossref', 'first-page': 'e28940', 'DOI': '10.1002/jmv.28940', 'article-title': 'Real-world effectiveness of azvudine: Elixir or equivocal answer?', 'volume': '95', 'author': 'Y Gao', 'year': '2023', 'journal-title': 'Journal of medical virology'}, { 'issue': '7', 'key': 'pone.0298772.ref024', 'doi-asserted-by': 'crossref', 'first-page': 'e28926', 'DOI': '10.1002/jmv.28926', 'article-title': 'Evaluate clinical effectiveness of Azvudine with data rather than ' 'speculation', 'volume': '95', 'author': 'D Li', 'year': '2023', 'journal-title': 'Journal of Medical Virology'}, { 'key': 'pone.0298772.ref025', 'first-page': '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', 'volume': '14', 'author': 'W Anhua', 'journal-title': 'Frontiers in Pharmacology'}, { 'key': 'pone.0298772.ref026', 'doi-asserted-by': 'crossref', 'first-page': '1143485', 'DOI': '10.3389/fmed.2023.1143485', 'article-title': 'Serial viral load analysis by DDPCR to evaluate FNC efficacy and safety ' 'in the treatment of mild cases of COVID-19', 'volume': '10', 'author': 'RM da Silva', 'year': '2023', 'journal-title': 'Frontiers in Medicine'}, { 'key': 'pone.0298772.ref027', 'doi-asserted-by': 'crossref', 'first-page': '1215916', 'DOI': '10.3389/fmed.2023.1215916', 'article-title': 'PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY: ' 'STUDY ON SAFETY AND CLINICAL EFFICACY OF AZVUDINE (FNC) IN MODERATE ' 'COVID-19 PATIENTS', 'volume': '10', 'author': 'SB De Souza', 'journal-title': 'Frontiers in Medicine'}, { 'key': 'pone.0298772.ref028', 'author': 'X Han', 'year': '2023', 'journal-title': 'Effectiveness and Optimal Timing of Azvudine in COVID-19 Patients: A ' 'Multi-center Retrospective Study in Beijing, China'}, { 'key': 'pone.0298772.ref029', 'doi-asserted-by': 'crossref', 'first-page': '110824', 'DOI': '10.1016/j.intimp.2023.110824', 'article-title': 'Azvudine and mortality in patients with coronavirus disease 2019: A ' 'retrospective cohort study', 'volume': '124', 'author': 'B Liu', 'year': '2023', 'journal-title': 'International Immunopharmacology'}, { 'issue': '9', 'key': 'pone.0298772.ref030', 'doi-asserted-by': 'crossref', 'first-page': '4925', 'DOI': '10.21037/jtd-23-1093', 'article-title': 'Real-world effectiveness of azvudine for patients infected with the ' 'SARS-CoV-2 omicron subvariant BA. 5 in an intensive care unit', 'volume': '15', 'author': 'X Qi', 'year': '2023', 'journal-title': 'Journal of Thoracic Disease'}, { 'issue': '8', 'key': 'pone.0298772.ref031', 'doi-asserted-by': 'crossref', 'first-page': 'e29007', 'DOI': '10.1002/jmv.29007', 'article-title': 'Azvudine therapy of common COVID‐19 in hemodialysis patients', 'volume': '95', 'author': 'S Shang', 'year': '2023', 'journal-title': 'Journal of Medical Virology'}, { 'key': 'pone.0298772.ref032', 'article-title': 'Composite interventions on outcomes of severely and critically ill ' 'patients with COVID-19 in Shanghai, China', 'author': 'J Shao', 'year': '2023', 'journal-title': 'medRxiv'}, { 'issue': '7', 'key': 'pone.0298772.ref033', 'doi-asserted-by': 'crossref', 'first-page': 'e28947', 'DOI': '10.1002/jmv.28947', 'article-title': 'Oral azvudine for mild‐to‐moderate COVID‐19 in high risk, ' 'nonhospitalized adults: Results of a real‐world study', 'volume': '95', 'author': 'H Yang', 'year': '2023', 'journal-title': 'Journal of Medical Virology'}, { 'key': 'pone.0298772.ref034', 'first-page': '2023', 'article-title': 'Comparison of the Different Medications for COVID-19 in Kidney ' 'Transplant Recipients. Authorea', 'volume': '26', 'author': 'JP Yingxin Fu', 'journal-title': 'June'}, { 'issue': '8', 'key': 'pone.0298772.ref035', 'doi-asserted-by': 'crossref', 'first-page': '2087', 'DOI': '10.1007/s40121-023-00845-7', 'article-title': 'Is Azvudine Comparable to Nirmatrelvir-Ritonavir in Real-World Efficacy ' 'and Safety for Hospitalized Patients with COVID-19? A Retrospective ' 'Cohort Study', 'volume': '12', 'author': 'Q Zhao', 'year': '2023', 'journal-title': 'Infectious Diseases and Therapy'}, { 'key': 'pone.0298772.ref036', 'doi-asserted-by': 'crossref', 'first-page': '6053', 'DOI': '10.2147/IDR.S423725', 'article-title': 'Efficacy of Nirmatrelvir-Ritonavir versus Azvudine for COVID-19 ' 'treatment in Tibet: A retrospective study', 'author': 'X Zhao', 'year': '2023', 'journal-title': 'Infection and Drug Resistance'}, { 'key': 'pone.0298772.ref037', 'author': 'Y Zhou', 'year': '2023', 'journal-title': 'Azvudine and Nirmatrelvir–Ritonavir in Hospitalised Patients with ' 'Moderate–To–Severe COVID–19: Emulation of a Randomised Target Trial'}, { 'key': 'pone.0298772.ref038', 'article-title': 'Azvudine Reduce the In-Hospital Mortality of Patients with COVID-19 ' 'Pneumonia', 'author': 'K Zong', 'year': '2023', 'journal-title': 'Available at SSRN 4380058'}, { 'issue': '7', 'key': 'pone.0298772.ref039', 'doi-asserted-by': 'crossref', 'first-page': '993', 'DOI': '10.3390/biom11070993', 'article-title': 'COVID-19: unmasking emerging SARS-CoV-2 variants, vaccines and ' 'therapeutic strategies', 'volume': '11', 'author': 'R Raman', 'year': '2021', 'journal-title': 'Biomolecules'}, { 'issue': '2', 'key': 'pone.0298772.ref040', 'doi-asserted-by': 'crossref', 'first-page': 'e28471', 'DOI': '10.1002/jmv.28471', 'article-title': 'Nirmatrelvir–ritonavir for the treatment of COVID‐19 patients: A ' 'systematic review and meta‐analysis', 'volume': '95', 'author': 'HA Cheema', 'year': '2023', 'journal-title': 'Journal of Medical Virology'}, { 'issue': '4', 'key': 'pone.0298772.ref041', 'doi-asserted-by': 'crossref', 'first-page': 'e28732', 'DOI': '10.1002/jmv.28732', 'article-title': 'Nirmatrelvir–ritonavir compared with other antiviral drugs for the ' 'treatment of COVID‐19 patients: A systematic review and meta‐analysis', 'volume': '95', 'author': 'F Tian', 'year': '2023', 'journal-title': 'Journal of Medical Virology'}, { 'issue': '10', 'key': 'pone.0298772.ref042', 'doi-asserted-by': 'crossref', 'first-page': 'e0284006', 'DOI': '10.1371/journal.pone.0284006', 'article-title': 'Effectiveness of nirmatrelvir-ritonavir for the treatment of patients ' 'with mild to moderate COVID-19 and at high risk of hospitalization: ' 'Systematic review and meta-analyses of observational studies', 'volume': '18', 'author': 'CG Souza KM', 'year': '2023', 'journal-title': 'PLoS ONE'}, { 'issue': '5', 'key': 'pone.0298772.ref043', 'doi-asserted-by': 'crossref', 'first-page': 'e2473', 'DOI': '10.1002/rmv.2473', 'article-title': 'Efficacy and safety of paxlovid (nirmatrelvir/ritonavir) in the ' 'treatment of COVID‐19: An updated meta‐analysis and trial sequential ' 'analysis', 'volume': '33', 'author': 'H Tian', 'year': '2023', 'journal-title': 'Reviews in Medical Virology'}], 'container-title': 'PLOS ONE', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://dx.plos.org/10.1371/journal.pone.0298772', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 6, 13]], 'date-time': '2024-06-13T17:33:52Z', 'timestamp': 1718300032000}, 'score': 1, 'resource': {'primary': {'URL': 'https://dx.plos.org/10.1371/journal.pone.0298772'}}, 'subtitle': [], 'editor': [{'given': 'Gilbert Sterling', 'family': 'Octavius', 'sequence': 'first', 'affiliation': []}], 'short-title': [], 'issued': {'date-parts': [[2024, 6, 13]]}, 'references-count': 43, 'journal-issue': {'issue': '6', 'published-online': {'date-parts': [[2024, 6, 13]]}}, 'URL': 'http://dx.doi.org/10.1371/journal.pone.0298772', 'relation': {}, 'ISSN': ['1932-6203'], 'subject': [], 'container-title-short': 'PLoS ONE', 'published': {'date-parts': [[2024, 6, 13]]}}
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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