Bienvenu Anne-Lise, Marty Aileen M, Jones Malcolm K, Picot Stephane
Groupement Hospitalier Nord, Service Pharmacie, Hospices Civils de Lyon, Lyon, France.
Univ Lyon, Malaria Research Unit, ICBMS, UMR 5246 CNRS INSA CPE, F-69100, Lyon, France.
One Health. 2020 Dec;10:100141. doi: 10.1016/j.onehlt.2020.100141. Epub 2020 May 19.
In the absence of a vaccine the medical and scientific community is looking intensely at utilizing a pre or post exposure drug that could decrease viremia. The search for a medication that could reduce risk of serious disease, and ideally of any manifestation of disease from SARS-CoV2, and of asymptomatic shedding of SARS-CoV2 is of urgent interest. Repurposing existing pharmaceuticals is among the approaches to achieve these ends. We performed a systematic review of all interventional studies registered in ClinicalTrials.gov with a focus on one repurposed drug, Hydroxychloroquine (HCQ). The detailed analysis of these studies, some of them already recruiting, provide an overall picture of HCQ use as a COVID-19 prophylaxis around the world. Among the included studies, all but three were randomized and parallel and most of them (74%, 23/31) were double-blinded to quadruple-blinded studies. We found a great diversity in dosing and nearly all the possible scientifically reasonable regimens are under evaluation. This diversity offers benefits as well as challenges. Importantly, the final analysis of these trials should be done through an extensive reading of the results in regard to the clinical design, it will be crucial to carefully read and evaluate the results of each study in regards to the clinical design rather than quickly glancing a 140 characters-based social media message announcing the failure or success of a drug against a disease.
在没有疫苗的情况下，医学界和科学界正密切关注使用暴露前或暴露后药物来降低病毒血症。寻找一种能够降低严重疾病风险，理想情况下还能降低感染新冠病毒后任何疾病表现以及新冠病毒无症状传播风险的药物，是当务之急。重新利用现有药物是实现这些目标的方法之一。我们对在ClinicalTrials.gov上注册的所有干预性研究进行了系统综述，重点关注一种重新利用的药物——羟氯喹（HCQ）。对这些研究的详细分析（其中一些已经在招募受试者），全面展示了HCQ在全球范围内作为新冠病毒预防药物的使用情况。在纳入的研究中，除三项外均为随机平行研究，且大多数研究（74%，23/31）为双盲至四盲研究。我们发现给药方式存在很大差异，几乎所有科学合理的给药方案都在评估之中。这种差异既带来了好处，也带来了挑战。重要的是，这些试验的最终分析应通过广泛阅读有关临床设计的结果来进行，仔细阅读和评估每项研究关于临床设计的结果至关重要，而不是快速浏览一条基于140个字符的社交媒体消息，宣布一种药物对抗疾病的失败或成功。
