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根据2019年12月的报道,新冠病毒肺炎(coronavirus disease 2019,COVID-19)是由一种新型冠状病毒引起的肺炎.到目前为止,还没有发现能够治疗这种病毒的有效药物.本研究是一项在黑龙江省10个研究中心正在进行的多中心双盲随机对照试验(randomized controlled trial,RCT),其目的是研究与安慰剂相比,特力阿扎维林(triazavirin,TZV)治疗COVID-19患者的疗效和安全性.共计划招募240名COVID-19患者参加这项试验.咽拭子病毒核酸检测为阳性的受试者被随机(1:1)分为两组:使用标准治疗加TZV或标准治疗加安慰剂,进行为期7 d的治疗和为期21 d的随访.主要结局是受试者临床改善的时间.次要结局包括临床改善率、退热时间、肺内炎症明显吸收的平均时间和人数比例、病毒核酸转阴率、病死率以及重症和危重症患者的转化率.整个试验过程将对不良事件,严重不良事件,肝功能、肾功能以及合并用药进行监测和记录.本试验的结果可为临床医生治疗COVID-19提供循证医学的证据和建议.“,”The coronavirus disease 2019 (COVID-19), a pneumonia caused by a novel coronavirus, was reported in December 2019. COVID-19 is highly contagious and has rapidly developed from a regional epidemic into a global pandemic. As yet, no effective drugs have been found to treat this virus. This study, an ongoing multicenter and blind randomized controlled trial (RCT), is being conducted at ten study sites in Heilongjiang Province, China, to investigate the efficacy and safety of Triazavirin (TZV) versus its placebo in COVID-19 patients. A total of 240 participants with COVID-19 are scheduled to be enrolled in this trial. Participants with positive tests of throat swab virus nucleic acid are randomized (1:1) into two groups:standard therapy plus TZV or standard therapy plus placebo for a 7-day treatment with a 21-day follow-up. The primary outcome is the time to clinical improvement of the subjects. Secondary outcomes include clinical improvement rate, time to alleviation of fever, mean time and proportion of obvious inflamma-tory absorption in the lung, conversion rate of repeated negative virus nucleic acid tests, mortality rate, and conversion rate to severe and critically severe patients. Adverse events, serious adverse events, liver function, kidney function, and concurrent treatments will be monitored and recorded throughout the trial. The results of this trial should provide evidence-based recommendations to clinicians for the treat-ment of COVID-19.