Lumkul Lalita, Tanasombatkul Krittai, Nitikaroon Phongsak, Morasert Thotsaporn, Phinyo Phichayut
Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Center of Multidisciplinary Technology for Advanced Medicine (CMUTEAM), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
PLoS One. 2025 Jun 4;20(6):e0324903. doi: 10.1371/journal.pone.0324903. eCollection 2025.
Favipiravir, an antiviral agent, has been widely used to treat COVID-19 due to its potential mechanism of action, despite limited evidence of its efficacy in moderate to severe cases.
This study aimed to evaluate the efficacy of favipiravir in improving in-hospital mortality outcomes among patients with moderate to severe COVID-19 through an emulation of a target trial.
We emulated a target trial using observational data from Bussarakham field hospital, Thailand between May 14 and September 20, 2021. Patients were categorized into three groups: those receiving favipiravir with dexamethasone (FPV with Dexa), favipiravir alone (FPV), and symptomatic treatment (ST). In-hospital mortality within 30 days was the primary outcome.
From 18,184 patients admitted to the hospital, a total of 3,193 moderate to severe COVID-19 cases were included. Of these, 2,256 (70.65%) received FPV with Dexa, 828 (25.93%) received FPV, and 109 (3.41%) received ST. The restricted mean survival times were 29.68 days (95% CI: 29.52, 29.84) for FPV with Dexa, 29.46 days (95% CI: 29.22, 29.71) for FPV, and 28.14 days (95% CI: 26.51, 29.76) for ST. Only FPV showed marginally significant difference when compared to ST. However, there was a trend in prolonging survival time in FPV with Dexa group, and the results were more pronounced in severe and hypoxic patients.
Our emulated target trial suggests favipiravir, especially with dexamethasone, offers a modest survival benefit in moderate to severe COVID-19, particularly in hypoxic patients. It supports favipiravir as a practical antiviral in settings where other antivirals are not available. Further randomized controlled studies are needed to confirm its role, alongside standard corticosteroid therapy.
法匹拉韦作为一种抗病毒药物,尽管在中重度病例中的疗效证据有限,但因其潜在的作用机制已被广泛用于治疗新冠肺炎。
本研究旨在通过模拟目标试验来评估法匹拉韦对改善中重度新冠肺炎患者院内死亡结局的疗效。
我们利用泰国武里南野战医院2021年5月14日至9月20日的观察性数据模拟了一项目标试验。患者被分为三组:接受法匹拉韦联合地塞米松治疗的患者(法匹拉韦联合地塞米松组)、单独接受法匹拉韦治疗的患者(法匹拉韦组)和接受对症治疗的患者(对症治疗组)。30天内的院内死亡率是主要结局。
在18184名入院患者中,共纳入3193例中重度新冠肺炎病例。其中,2256例(70.65%)接受法匹拉韦联合地塞米松治疗,828例(25.93%)接受法匹拉韦治疗,109例(3.41%)接受对症治疗。法匹拉韦联合地塞米松组的受限平均生存时间为29.68天(95%CI:29.52,29.84),法匹拉韦组为29.46天(95%CI:29.22,29.71),对症治疗组为28.14天(95%CI:26.51,29.76)。与对症治疗组相比,只有法匹拉韦组显示出边缘显著差异。然而,法匹拉韦联合地塞米松组有延长生存时间的趋势,且在重症和缺氧患者中结果更明显。
我们模拟的目标试验表明,法匹拉韦,尤其是与地塞米松联合使用时,对中重度新冠肺炎患者有适度的生存获益,特别是在缺氧患者中。这支持法匹拉韦在没有其他抗病毒药物的情况下作为一种实用的抗病毒药物。需要进一步的随机对照研究来证实其作用,以及标准皮质类固醇疗法的作用。