Menzies School of Health Research, Darwin, NT.
John Hunter Hospital, Newcastle, NSW.
Med J Aust. 2020 Jul;213(2):86-93. doi: 10.5694/mja2.50673. Epub 2020 Jun 27.
Since coronavirus disease 2019 (COVID-19) emerged in Wuhan, China in December 2019 and spread around the world, over 1100 clinical studies have been registered globally on clinical trials registries, including over 500 randomised controlled trials. Such rapid development and launch of clinical trials is impressive but presents challenges, including the potential for duplication and competition. There is currently no known effective treatment for COVID-19. In order to focus on those studies most likely to influence clinical practice, we summarise the 31 currently registered randomised trials with a target sample size of at least 1000 participants. We have grouped these trials into four categories: prophylaxis; treatment of outpatients with mild COVID-19; treatment of hospitalised patients with moderate COVID-19; and treatment of hospitalised patients with moderate or severe disease. The most common therapeutic agent being trialled currently is hydroxychloroquine (24 trials with potential sample size of over 25 000 participants), followed by lopinavir-ritonavir (seven trials) and remdesevir (five trials) There are many candidate drugs in pre-clinical and early phase development, and these form a pipeline for future large clinical trials if current candidate therapies prove ineffective or unsafe.
自 2019 年 12 月中国武汉爆发 2019 冠状病毒病(COVID-19)并在全球蔓延以来,全球临床试验注册机构已注册了超过 1100 项临床研究,其中包括 500 多项随机对照试验。如此迅速地开展和启动临床试验令人印象深刻,但也带来了挑战,包括潜在的重复和竞争。目前尚无已知有效的 COVID-19 治疗方法。为了关注最有可能影响临床实践的研究,我们总结了目前已注册的 31 项目标样本量至少为 1000 名参与者的随机试验。我们将这些试验分为四类:预防;治疗轻症 COVID-19 门诊患者;治疗中症 COVID-19 住院患者;以及治疗中症或重症 COVID-19 住院患者。目前正在试验的最常见治疗药物是羟氯喹(24 项试验,潜在样本量超过 25000 名参与者),其次是洛匹那韦-利托那韦(7 项试验)和瑞德西韦(5 项试验)。有许多候选药物处于临床前和早期开发阶段,如果当前候选疗法证明无效或不安全,这些候选药物将为未来的大型临床试验提供一个渠道。