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 randomization. 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 randomized 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 vs. 12 d; riskratio (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% vs. 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.

中文翻译：

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三氮杂韦林治疗 2019 年冠状病毒病的有效性和安全性：一项随机对照试验

目前尚无治疗方法被证明可有效治疗由严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 引起的 2019 年冠状病毒病 (COVID-19)。为了评估 Triazavirin 治疗 COVID-19 的有效性和安全性，我们对住院的 COVID-19 成年患者进行了一项随机、双盲对照试验。参与者来自 10 个地点，并以 1:1 的比例随机分为研究组。患者接受 Triazavirin 250 mg 与安慰剂的治疗，每天 3 至 4 次，持续 7 天。主要结局被设定为临床改善的时间，定义为随机分组后 28 天内体温、呼吸频率、血氧饱和度、咳嗽和胸部计算机断层扫描（CT）显示的肺部感染吸收正常化。次要结局包括主要结局的各个组成部分、肺部炎症吸收的平均时间和比例，以及咽拭子采样的 SARS-CoV-2 核酸检测重复阴性的转化率。记录伴随的治疗、不良事件和严重不良事件。我们的研究在招募了52名患者后就停止了，因为参与医院的新增感染人数大幅下降。我们将 52 名患者随机分组，接受 Triazavirin (n = 26) 或安慰剂 (n = 26) 治疗。我们发现临床改善的时间没有差异（中位数为 7 天与 12 天；风险比 (RR)，2.0；95% 置信区间 (CI)，0.7–5.6；p = 0.2），临床改善发生在 10 天内。 Triazavirin 组的 6 名患者和安慰剂组的 6 名患者（38.5% vs. 23.1%，RR，2.1；95% CI，0.6–7.0；p = 0.2）。主要结局的所有组成部分均在 28 天内恢复正常，但肺部感染的吸收除外（三氮唑核苷 50.0%，安慰剂 26.1%）。Triazavirin 组的患者较少使用呼吸、心脏、肾脏、肝脏或凝血支持的伴随治疗。尽管没有发现具有统计学意义的证据表明 Triazavirin 对 COVID-19 患者有益，但我们的观察表明，由于其抗病毒作用，使用它来治疗 COVID-19 可能会带来益处。还需要进一步研究来证实。