护理标准(SoC)治疗的概念通常用于临床试验中。然而,在突发疾病的背景下,例如COVID-19,没有确定的有效治疗方法,目前尚不清楚研究者在早期临床试验中认为的SoC是什么.这项研究的目的是分析和分类随机对照试验(RCT)注册报告的SoC,以及在学术期刊和预印本服务器上发表的关于COVID-19治疗干预措施的RCT。
我们进行了一项横断面研究。我们包括在试验登记处注册的RCT,和/或发表在学术期刊上,和/或在预印本服务器medRxiv和bioRxiv上发布(任何阶段;任何招募状态;任何语言),旨在比较与COVID-19和SoC相关的治疗干预措施,从2020年1月1日至2020年10月8日。使用“标准”治疗的研究有资格纳入,如果他们报告他们使用标准,通常,常规,或常规治疗。当我们发现如此多的RCT报告时,我们将这些多个来源视为一个分析单位。
在分析中包括的737项独特试验中,152(21%)报告说SoC是由机构或国家当局提出的。有129(18%)试验报告了SoC的组件;其余试验仅报告他们使用SoC,没有进一步的细节。在这129项试验中,SoC的组件数量从1个到10个不等。SoC中最常用的干预组是抗寄生虫药(62%的试验),抗病毒药物(57%),抗生素(31%),氧气(17%),抗血栓药/抗凝剂(14%),维生素(13%),免疫调节剂(13%),皮质类固醇(12%),镇痛药/退烧药(12%)。SoC中使用了这些干预措施的各种组合,结合多达7种不同类型的干预措施。Posology,定时,SoC组件的给药方法经常没有报告。
在大流行的前9个月注册或发布的大多数关于COVID-19治疗的RCT(82%)没有描述他们使用的“护理标准”。其中许多干预措施,到现在,被证明是无效的,甚至是有害的。
The concept of standard of care (SoC) treatment is commonly utilized in clinical trials. However, in a setting of an emergent disease, such as COVID-19, where there is no established effective treatment, it is unclear what the investigators considered as the SoC in early clinical trials. The aim of this study was to analyze and classify SoC reported in randomized controlled trial (RCT) registrations and RCTs published in scholarly journals and on preprint servers about treatment interventions for COVID-19.
We conducted a cross-sectional study. We included RCTs registered in a trial registry, and/or published in a scholarly journal, and/or published on preprint servers medRxiv and bioRxiv (any phase; any recruitment status; any language) that aim to compare treatment interventions related to COVID-19 and SoC, available from January 1, 2020, to October 8, 2020. Studies using \"standard\" treatment were eligible for inclusion if they reported they used standard, usual, conventional, or routine treatment. When we found such multiple reports of an RCT, we treated those multiple sources as one unit of analysis.
Among 737 unique trials included in the analysis, 152 (21%) reported that SoC was proposed by the institutional or national authority. There were 129 (18%) trials that reported component(s) of SoC; the remaining trials simply reported that they used SoC, with no further detail. Among those 129 trials, the number of components of SoC ranged from 1 to 10. The most commonly used groups of interventions in the SoC were antiparasitics (62% of the trials), antivirals (57%), antibiotics (31%), oxygen (17%), antithrombotics/anticoagulants (14%), vitamins (13%), immunomodulatory agents (13%), corticosteroids (12%), analgesics/antipyretics (12%). Various combinations of those interventions were used in the SoC, with up to 7 different types of interventions combined. Posology, timing, and method of administration were frequently not reported for SoC components.
Most RCTs (82%) about treatment for COVID-19 that were registered or published in the first 9 months of the pandemic did not describe the \"standard of care\" they used. Many of those interventions have, by now, been shown as ineffective or even detrimental.