The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries.
The Landscape of Emerging Randomized Clinical Trial Evidence for COVID-19 Disease Stages: A Systematic Review of Global Trial Registries.
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DOI：
10.2147/idr.s288399
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发表时间：
2020
影响因子：
3.9
通讯作者：
Mills EJ
中科院分区：
文献类型：
--
作者：
Dillman A;Zoratti MJ;Park JJH;Hsu G;Dron L;Smith G;Harari O;Rayner CR;Zannat NE;Gupta A;Mackay E;Arora P;Lee Z;Mills EJ
针对新型冠状病毒病（COVID-19）大流行，出现了大量随机对照试验（RCT）。了解试验在不同环境中的分布对于指导未来的研究重点和努力非常重要。本综述的目的是按照疾病进展阶段（从暴露前到住院）描述COVID-19 RCT的新证据基础。我们整理了国际注册中心的试验数据：ClinicalTrials.gov;国际标准随机对照试验编号注册中心;中国临床试验注册中心;临床研究信息服务中心;欧盟临床试验注册中心;伊朗临床试验注册中心;日本主要注册中心网络;德国临床试验注册中心（截至2020年10月7日）。国际登记研究中的有效COVID-19 RCT符合纳入条件。我们提取了试验状态、干预、对照、样本量和临床背景，以生成描述性频率、网络图插图和统计分析，包括比值比和Mann-Whitney U检验。我们的检索确定了11503项针对COVID-19注册的临床试验，并确定了2388项RCT。在排除了45项暂停的随机对照试验和480项疾病分期不明确或未报告的试验后，纳入了1863项正在进行的随机对照试验，并将其分类为四个广泛的疾病分期：暴露前（n=107）;暴露后（n=208）;门诊治疗（n=266）;住院治疗，包括重症监护室（n=1376）。在所有疾病阶段，大多数试验有两个组（n=1500/1863，80.52%），最常见的包括（羟基）氯喹（n=271/1863，14.55%），并且是基于美国的（n=408/1863，21.90%）。基于美国的试验纳入（羟基）氯喹的几率低于其他国家的试验（OR：0.63，95% CI：0.45-0.90），与其他地理区域相比，两组的几率相似（OR：1.05，95% CI：0.80-1.38）。不同环境下的试验数量存在显著差异，对非住院患者的研究有限。作为减少感染和减轻COVID-19的健康、社会和经济负担的一种手段，关注暴露前和暴露后以及门诊患者是值得的。
A multitude of randomized controlled trials (RCTs) have emerged in response to the novel coronavirus disease (COVID-19) pandemic. Understanding the distribution of trials among various settings is important to guide future research priorities and efforts. The purpose of this review was to describe the emerging evidence base of COVID-19 RCTs by stages of disease progression, from pre-exposure to hospitalization. We collated trial data across international registries: ClinicalTrials.gov; International Standard Randomised Controlled Trial Number Registry; Chinese Clinical Trial Registry; Clinical Research Information Service; EU Clinical Trials Register; Iranian Registry of Clinical Trials; Japan Primary Registries Network; German Clinical Trials Register (up to 7 October 2020). Active COVID-19 RCTs in international registries were eligible for inclusion. We extracted trial status, intervention(s), control, sample size, and clinical context to generate descriptive frequencies, network diagram illustrations, and statistical analyses including odds ratios and the Mann–Whitney U-test. Our search identified 11503 clinical trials registered for COVID-19 and identified 2388 RCTs. After excluding 45 suspended RCTs and 480 trials with unclear or unreported disease stages, 1863 active RCTs were included and categorized into four broad disease stages: pre-exposure (n=107); post-exposure (n=208); outpatient treatment (n=266); hospitalization, including the intensive care unit (n=1376). Across all disease stages, most trials had two arms (n=1500/1863, 80.52%), most often included (hydroxy)chloroquine (n=271/1863, 14.55%) and were US-based (n=408/1863, 21.90%). US-based trials had lower odds of including (hydroxy)chloroquine than trials in other countries (OR: 0.63, 95% CI: 0.45–0.90) and similar odds of having two arms compared to other geographic regions (OR: 1.05, 95% CI: 0.80–1.38). There is a marked difference in the number of trials across settings, with limited studies on non-hospitalized persons. Focus on pre- and post-exposure, and outpatients, is worthwhile as a means of reducing infections and lessening the health, social, and economic burden of COVID-19.