PDF(Pubmed)
Abstract：
UNASSIGNED: Multisystem Inflammatory Syndrome in Children (MIS-C), which occurs 2-6 weeks after initial exposure to SARS-CoV-2, was first identified in early 2020 when patients presented with fever and significant inflammation, often requiring management in the intensive care unit. To date, there has been no clinical trial to determine the most effective treatment. This study compares anti-inflammatory treatments that were selected based on current treatments for Kawasaki disease, a coronary artery vasculitis that shares many clinical features with MIS-C.
UNASSIGNED: This randomized, comparative effectiveness trial of children with MIS-C uses the small N Sequential Multiple Assignment Randomized Trial (snSMART) design for rare diseases to compare multiple therapies within an individual. Study participants were treated first with intravenous immunoglobulin (IVIG), and if needed, subjects were then randomized to one of three additional treatments (steroids, anakinra, or infliximab). Participants were re-randomized to remaining treatments if they did not demonstrate clinical improvement.
UNASSIGNED: This trial continues to enroll eligible participants to determine the most effective therapies in addition to IVIG and best order in which to use them to treat MIS-C.
UNASSIGNED: NCT04898231.
UNASSIGNED: This randomized, comparative effectiveness trial of children with MIS-C uses the small N Sequential Multiple Assignment Randomized Trial (snSMART) design for rare diseases to compare multiple therapies within an individual. Study participants were treated first with intravenous immunoglobulin (IVIG), and if needed, subjects were then randomized to one of three additional treatments (steroids, anakinra, or infliximab). Participants were re-randomized to remaining treatments if they did not demonstrate clinical improvement.
UNASSIGNED: This trial continues to enroll eligible participants to determine the most effective therapies in addition to IVIG and best order in which to use them to treat MIS-C.
UNASSIGNED: NCT04898231.
摘要：
未经证实：儿童多系统炎症综合征（MIS-C），首次暴露于SARS-CoV-2后2-6周，首次发现于2020年初，当时患者出现发烧和严重炎症，通常需要在重症监护室进行管理。迄今为止,目前还没有临床试验来确定最有效的治疗方法.这项研究比较了根据川崎病的当前治疗方法选择的抗炎治疗方法，与MIS-C具有许多临床特征的冠状动脉血管炎
未经批准：这是随机的，MIS-C患儿的疗效比较试验使用针对罕见疾病的小型N序贯多重分配随机试验(snSMART)设计,以比较个体内的多种治疗方法.研究参与者首先接受静脉注射免疫球蛋白（IVIG）治疗，如果需要的话,然后将受试者随机分为三种其他治疗方法之一(类固醇，anakinra,或英夫利昔单抗）。如果参与者没有表现出临床改善，他们将被重新随机分配到剩余的治疗中。
UNASSIGNED：该试验继续招募符合条件的参与者，以确定除IVIG外最有效的疗法以及使用它们治疗MIS-C的最佳顺序。
未经评估：NCT04898231。
未经批准：这是随机的，MIS-C患儿的疗效比较试验使用针对罕见疾病的小型N序贯多重分配随机试验(snSMART)设计,以比较个体内的多种治疗方法.研究参与者首先接受静脉注射免疫球蛋白（IVIG）治疗，如果需要的话,然后将受试者随机分为三种其他治疗方法之一(类固醇，anakinra,或英夫利昔单抗）。如果参与者没有表现出临床改善，他们将被重新随机分配到剩余的治疗中。
UNASSIGNED：该试验继续招募符合条件的参与者，以确定除IVIG外最有效的疗法以及使用它们治疗MIS-C的最佳顺序。
未经评估：NCT04898231。
