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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'abstract': '<jats:sec><jats:title>Background</jats:title><jats:p>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 '
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'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 '
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