Department of Pharmacology and Toxicology, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia.
Department of Clinical Pharmacy, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia.
Front Public Health. 2023 Mar 9;11:1144325. doi: 10.3389/fpubh.2023.1144325. eCollection 2023.
Monkeypox (mpox), a zoonotic viral infection, poses a global threat that is being acknowledged at the national and international levels. This systematic review aims to identify and characterize interventional clinical trials for mpox.
All interventional clinical trials registered at ClinicalTrials.gov for mpox were searched up to January 6, 2023. We described the characteristics of interventional clinical trials, and drug interventions (including drugs and vaccines).
As of January 6, 2023, there were 10 clinical trials in the ClinicalTrials.gov registry that met our criteria. Most of the interventional clinical trials were focused on the treatment ( = 4, 40%) and prevention ( = 4, 40%) of mpox. From the 10 trials, 50% used random treatment allocation, and six (60%) chose the parallel assignment intervention model. All 10 studies were blinded, and six were open-label blinded. The largest proportion of the clinical trials ( = 4, 40%) were registered in Europe, followed by America ( = 3, 30%) and Africa and others ( = 3, 30%). The JYNNEOS vaccine (40%), followed by Tecovirimat (30%) were the most frequently studied drugs used against mpox.
A limited number of clinical trials have been registered on ClinicalTrials.gov since the first case of mpox was reported. Therefore, there is an urgent need to conduct large-scale randomized clinical trials to assess the safety and efficacy of the drugs and vaccines being used against the mpox virus.
猴痘（mpox）是一种人畜共患的病毒性感染，正在引起国家和国际层面的关注，构成全球性威胁。本系统评价旨在识别和描述 mpox 的干预性临床试验。
检索截至 2023 年 1 月 6 日在 ClinicalTrials.gov 注册的针对 mpox 的所有干预性临床试验。我们描述了干预性临床试验的特征以及药物干预措施（包括药物和疫苗）。
截至 2023 年 1 月 6 日，ClinicalTrials.gov 注册了 10 项符合我们标准的临床试验。大多数干预性临床试验侧重于 mpox 的治疗（=4，40%）和预防（=4，40%）。在这 10 项试验中，有 50%采用了随机治疗分配，6 项（60%）选择了平行分配干预模型。所有 10 项研究均采用了盲法，其中 6 项为开放性盲法。临床试验比例最大的是欧洲（=4，40%），其次是美洲（=3，30%）和非洲及其他地区（=3，30%）。使用最多的药物是 JYNNEOS 疫苗（40%），其次是 Tecovirimat（30%）。
自首例 mpox 病例报告以来，ClinicalTrials.gov 上仅注册了有限数量的临床试验。因此，迫切需要开展大规模随机临床试验，以评估针对 mpox 病毒使用的药物和疫苗的安全性和有效性。
