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Efficacy of azvudine plus dexamethasone in severe hospitalized patients with Omicron infection: a prospective multicenter study

Zhang et al., Frontiers in Cellular and Infection Microbiology, doi:10.3389/fcimb.2024.1390098
Nov 2024  
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Progression 43% Improvement Relative Risk Time to viral- 14% Azvudine for COVID-19  Zhang et al.  LATE TREATMENT Is late treatment with azvudine beneficial for COVID-19? Prospective study of 209 patients in China (December 2022 - April 2023) Lower progression (p=0.029) and faster viral clearance (p=0.017) c19early.org Zhang et al., Frontiers in Cellular an.., Nov 2024 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 = 0.000011 from 26 studies.
Lower risk for mortality, progression, and viral clearance.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
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.
risk of progression, 42.6% lower, RR 0.57, p = 0.03, treatment 28 of 165 (17.0%), control 13 of 44 (29.5%), NNT 8.0, death, ICU, or mechanical ventilation, day 28.
time to viral-, 14.4% lower, relative time 0.86, p = 0.02, treatment 165, control 44.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Zhang et al., 22 Nov 2024, prospective, China, peer-reviewed, 6 authors, study period 15 December, 2022 - 30 April, 2023. Contact: zengdaxiong@suda.edu.cn, xuguopeng2046@foxmail.com.
This PaperAzvudineAll
Efficacy of azvudine plus dexamethasone in severe hospitalized patients with Omicron infection: a prospective multicenter study
Meng-Lan Zhang, Xiao-Ying Wei, Nan Su, Jung-Hong Jiang, Guo-Peng Xu, Da-Xiong Zeng
Frontiers in Cellular and Infection Microbiology, doi:10.3389/fcimb.2024.1390098
Background: Azvudine (AZV), the first Chinese oral anti-coronavirus disease 2019 (COVID-19) drug, has shown substantial clinical benefits to viral clearance and prognosis in patients with mild and common COVID-19. However, there is no evidence in severe hospitalized COVID-19 patients. Methods: In this multicenter study, we analyzed 209 severe hospitalized COVID-19 patients in four hospitals. All the clinical data and the 28-day composite outcomes were recorded. All of the patients were categorized into two groups according to drug: the dexamethasone (DXM) group and the azvudine plus dexamethasone (AZV+DXM) group. Results: There were no differences in sex, age, BMI, and underlying diseases between the two groups. The ratio of the 28-day composite outcome was lower for the AZV+DXM group than that for the DXM group (16.97% vs. 31.82%, p = 0.029). The viral clearance time was shorter in the AZV+DXM group than in the DXM group (7.32 ± 2.57 vs. 8.55 ± 2.34 days, p = 0.017). The PaO 2 /FiO 2 levels on day 5 (258.89 ± 55.22 vs. 233.12 ± 60.51, p = 0.026) and day 10 (289.48 ± 44.09 vs. 261.52 ± 37.34, p = 0.015) were higher in the AZV +DXM group than the DXM group. However, data on the hospitalization duration of the two groups were similar. Cox analysis showed the benefit of AZV+DXM in the subgroups of ≥65 years old, multiple organ dysfunction syndrome (MODS), cerebrovascular disease, C-reactive protein (CRP) ≥70mg/L, and D-dimer ≥1 µg/L. Conclusion: This study is the first to indicate that treatment with AZV+DXM might benefit severe Omicron-infected patients compared with DXM treatment alone. This finding demonstrates, at least partly, the necessity of antiviral treatment in severe patients.
Ethics statement This study was approved by the institutional review board of Dushu Lake Hospital Affiliated to Soochow University (220143) . The studies were conducted in accordance with the local legislation and institutional requirements. The written informed consent was waived as we only collected all clinical data from anonymized data according to the policy for public health outbreak investigation of emerging infectious diseases issued by the National Health Commission of the People's Republic of China. Author contributions Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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However, there is no ' 'evidence in severe hospitalized COVID-19 ' 'patients.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>In this ' 'multicenter study, we analyzed 209 severe hospitalized COVID-19 patients in four hospitals. ' 'All the clinical data and the 28-day composite outcomes were recorded. All of the patients ' 'were categorized into two groups according to drug: the dexamethasone (DXM) group and the ' 'azvudine plus dexamethasone (AZV+DXM) ' 'group.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>There were no ' 'differences in sex, age, BMI, and underlying diseases between the two groups. The ratio of ' 'the 28-day composite outcome was lower for the AZV+DXM group than that for the DXM group ' '(16.97% <jats:italic>vs</jats:italic>. 31.82%, <jats:italic>p</jats:italic> = 0.029). The ' 'viral clearance time was shorter in the AZV+DXM group than in the DXM group (7.32 ± 2.57 ' '<jats:italic>vs</jats:italic>. 8.55 ± 2.34 days, <jats:italic>p</jats:italic> = 0.017). The ' 'PaO<jats:sub>2</jats:sub>/FiO<jats:sub>2</jats:sub> levels on day 5 (258.89 ± 55.22 ' '<jats:italic>vs</jats:italic>. 233.12 ± 60.51, <jats:italic>p</jats:italic> = 0.026) and day ' '10 (289.48 ± 44.09 <jats:italic>vs</jats:italic>. 261.52 ± 37.34, ' '<jats:italic>p</jats:italic> = 0.015) were higher in the AZV+DXM group than the DXM group. ' 'However, data on the hospitalization duration of the two groups were similar. Cox analysis ' 'showed the benefit of AZV+DXM in the subgroups of ≥65 years old, multiple organ dysfunction ' 'syndrome (MODS), cerebrovascular disease, C-reactive protein (CRP) ≥70mg/L, and D-dimer ≥1 ' 'µg/L.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>This study is ' 'the first to indicate that treatment with AZV+DXM might benefit severe Omicron-infected ' 'patients compared with DXM treatment alone. 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Late treatment
is less effective
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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