CATALYST trial protocol: A multicentre, open-label, phase II, multi-arm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults
CATALYST trial protocol: A multicentre, open-label, phase II, multi-arm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults
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CATALYST 试验方案：一项多中心、开放标签、II 期、多组试验，用于早期和加速评估住院成人中 COVID-19 的潜在治疗方法
DOI：
10.1101/2021.02.10.21251478
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发表时间：
2021
期刊：
影响因子：
--
通讯作者：
Veenith T
中科院分区：
文献类型：
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作者：
Veenith T
前言严重的SARS-CoV-2感染与免疫反应失调有关。炎性单核细胞和巨噬细胞是至关重要的，它们促进了损伤性、促炎性后遗症。因此，免疫调节是一种有吸引力的治疗策略，我们试图测试获得许可的和新型候选药物。方法和分析CATALYER试验是一项多臂、开放标签、多中心、II期平台试验，旨在确定候选新疗法，以改善新冠肺炎住院患者的预后。有生物标记物改善证据的治疗将在目前的国家第三阶段平台试验中提出进行更大规模的测试。住院16年，临床表现强烈提示为SARS-CoV-2肺炎(经胸部X光或CT扫描确诊，有或不有逆转录聚合酶链式反应阳性)和C反应蛋白≥40 mg/L的患者符合条件。主要的结果测量是CRP，从入院到第14天、出院或死亡连续测量。次要结果包括将世卫组织临床进展改进量表作为主要疗效评估。伦理和传播该议定书由东米德兰兹郡-诺丁汉2号研究伦理委员会批准(20/EM/0115)，并被授予紧急公共卫生地位；初步批准于2020年5月5日获得，当前协议版本(V.6.0)于2020年10月12日获得批准。MHRA还批准了所有协议版本。这项试验的结果将通过国家和国际介绍以及同行评议的出版物进行传播。试验注册号为EudraCT2020-001684-89，ISRCTN40580903。
IntroductionSevere SARS-CoV-2 infection is associated with a dysregulated immune response. Inflammatory monocytes and macrophages are crucial, promoting injurious, proinflammatory sequelae. Immunomodulation is, therefore, an attractive therapeutic strategy and we sought to test licensed and novel candidate drugs.Methods and analysisThe CATALYST trial is a multiarm, open-label, multicentre, phase II platform trial designed to identify candidate novel treatments to improve outcomes of patients hospitalised with COVID-19 compared with usual care. Treatments with evidence of biomarker improvements will be put forward for larger-scale testing by current national phase III platform trials. Hospitalised patients >16 years with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription PCR assay) and a C reactive protein (CRP) ≥40 mg/L are eligible. The primary outcome measure is CRP, measured serially from admission to day 14, hospital discharge or death. Secondary outcomes include the WHO Clinical Progression Improvement Scale as a principal efficacy assessment.Ethics and disseminationThe protocol was approved by the East Midlands-Nottingham 2 Research Ethics Committee (20/EM/0115) and given urgent public health status; initial approval was received on 5 May 2020, current protocol version (V.6.0) approval on 12 October 2020. The MHRA also approved all protocol versions. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.Trial registration numbersEudraCT2020-001684-89, ISRCTN40580903.