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目前,尚无有效疗法可治愈由严重急性呼吸综合征冠状病毒2(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)引起的新型冠状病毒肺炎(coronavirus disease 2019,COVID-19).为了评估抗病毒药物特力阿扎维林治疗COVID-19的有效性和安全性,本研究针对感染COVID-19的成年住院患者开展了一项随机双盲对照试验.本研究从10个分中心招募COVID-19患者,并将患者按1:1的比例随机分为两组.试验组的患者每天服用250 mg的特力阿扎维林药物3～4次,对照组患者则服用安慰剂,为期共7 d.主要结局指标为临床改善时间,临床改善时间的定义为随机分组28 d内患者的体温、呼吸频率、血氧饱和度、咳嗽频率和肺CT(计算机断层扫描,computed tomogra-phy)所显示的肺部感染吸收情况全部恢复正常的时间.次要结局指标包括主要结局指标的5个组成指标,及肺部感染吸收的平均时间和吸收比例,以及用咽拭子采样法连续两次SARS-CoV-2核酸检测阴性的转阴率.与此同时,记录合并的治疗药物、不良事件和严重不良事件.由于需要进行住院治疗的新增感染病例的减少,本研究在招募52名患者后便停止招募.将52名受试者随机分为服用特力阿扎维林药物的试验组(n=26)和服用安慰剂的对照组(n=26).结果显示,两组临床改善时间并无明显差异[中位数,7 d vs.12 d;风险比(RR)为2.0;95％置信区间(CI)为0.7～5.6;p=0.2].服用特力阿扎维林的试验组中有10名患者发生临床改善,服用安慰剂的对照组中有6名患者出现临床改善(38.5％vs.23.1％,RR为2.1;95％CI为0.6～7.0;p=0.2).除了肺部感染的吸收情况外(试验组50.0％,对照组26.1％),其余主要结局所观察指标均在28 d内恢复正常.此外,试验组的患者在呼吸系统、心脏、肾、肝或凝血功能等方面的合并治疗较对照组少.尽管特力阿扎维林药物对COVID-19患者的疗效尚未达到统计学上的显著性水平,但本研究结果表明,由于特力阿扎维林药物具有抗病毒作用,将其用于COVID-19的治疗也可能具有一定的疗效.对此,需要进一步的研究进行验证.“,”No therapeutics have been proven effective yet for the treatment of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To assess the efficacy and safety of Triazavirin therapy for COVID-19, we conducted a randomized, double-blinded controlled trial involving hospitalized adult patients with COVID-19. Participants were enrolled from ten sites, and were randomized into two arms of the study with a ratio of 1:1. Patients were treated with Triazavirin 250 mg versus a placebo three or four times a day for 7 d. The primary outcome was set as the time to clinical improvement, defined as normalization of body temperature, respiratory rate, oxygen saturation, cough, and absorption of pulmonary infection by chest computed tomography (CT) until 28 d after randomiza-tion. Secondary outcomes included individual components of the primary outcome, the mean time and proportion of inflammatory absorption in the lung, and the conversion rate to a repeated negative SARS-CoV-2 nucleic acid test of throat swab sampling. Concomitant therapeutic treatments, adverse events, and serious adverse events were recorded. Our study was halted after the recruitment of 52 patients, since the number of new infections in the participating hospitals decreased greatly. We random-ized 52 patients for treatment with Triazavirin (n=26) or a placebo (n=26). We found no differences in the time to clinical improvement (median, 7 d versus 12 d; risk ratio (RR), 2.0;95％ confidence interval (CI), 0.7–5.6; p=0.2), with clinical improvement occurring in ten patients in the Triazavirin group and six patients in the placebo group (38.5％versus 23.1％;RR, 2.1;95％CI, 0.6–7.0;p=0.2). All components of the primary outcome normalized within 28 d, with the exception of absorption of pulmonary infection (Triazavirin 50.0％, placebo 26.1％). Patients in the Triazavirin group used less frequent concomitant therapies for respiratory, cardiac, renal, hepatic, or coagulation supports. Although no statistically significant evidence was found to indicate that Triazavirin benefits COVID-19 patients, our observations indicated possible benefits from its use to treat COVID-19 due to its antiviral effects. Further study is required for confirmation.