CATALYST trial protocol: a multicentre, open-label, phase II, multiarm 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, multiarm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults.
复制标题
催化剂试验方案：一项多中心，开放标签，II期，多和多亚尔姆试验，用于对住院成年人的COVID-19的潜在治疗方法进行早期和加速评估。
DOI：
10.1136/bmjopen-2021-050202
复制
发表时间：
2021-11-11
期刊：
影响因子：
2.9
通讯作者：
CATALYST investigators
中科院分区：
文献类型：
--
作者：
Veenith T;Fisher BA;Slade D;Rowe A;Sharpe R;Thickett DR;Whitehouse T;Rowland M;Scriven J;Parekh D;Bowden SJ;Savage JS;Richards D;Bion J;Kearns P;Gates S;CATALYST Trial Investigators;CATALYST investigators
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，促进损伤性，促炎性后遗症。因此，免疫调节是一种有吸引力的治疗策略，我们试图测试许可和新的候选药物。CATALYST试验是一项多组、开放标签、多中心、II期平台试验，旨在确定候选的新型治疗方法，以改善因COVID-19住院的患者与常规治疗相比的结局。具有生物标志物改善证据的治疗将通过当前的国家III期平台试验进行更大规模的测试。年龄> 16岁、临床表现强烈提示SARS-CoV-2肺炎（经胸部X线或CT扫描证实，有或无阳性逆转录PCR检测）且C反应蛋白（CRP）≥ 40 mg/L的住院患者符合条件。主要结果指标是CRP，从入院到第14天、出院或死亡连续测量。次要结局包括WHO临床进展改善量表作为主要疗效评估。该方案获得了East Midlands-Nottingham 2研究伦理委员会（20/EM/0115）的批准，并获得紧急公共卫生状态;于2020年5月5日获得初始批准，于2020年10月12日获得当前方案版本（V.6.0）批准。MHRA还批准了所有方案版本。这项试验的结果将通过国家和国际报告以及同行评审的出版物传播。EudraCT 2020 - 001684 - 89，ISRCTN 40580903。
Severe 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. The 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. The 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. EudraCT2020-001684-89, ISRCTN40580903.
登录
查看更多内容
影响因子：
168.9
作者：
Huang, Chaolin;Wang, Yeming;Cao, Bin
通讯作者：
Cao, Bin
影响因子：
158.5
作者：
Ackermann, Maximilian;Verleden, Stijn E.;Jonigk, Danny
通讯作者：
Jonigk, Danny
DOI：
10.1016/j.xcrm.2020.100144
发表时间：
2020-11-17
期刊：
Cell reports. Medicine
影响因子：
--
作者：
Mueller AA;Tamura T;Crowley CP;DeGrado JR;Haider H;Jezmir JL;Keras G;Penn EH;Massaro AF;Kim EY
通讯作者：
Kim EY
COVID-19 患者支气管肺泡免疫细胞的单细胞景观。
影响因子：
82.9
作者：
Liao, Mingfeng;Liu, Yang;Zhang, Zheng
通讯作者：
Zhang, Zheng
影响因子：
15.1
作者：
Raman B;Cassar MP;Tunnicliffe EM;Filippini N;Griffanti L;Alfaro-Almagro F;Okell T;Sheerin F;Xie C;Mahmod M;Mózes FE;Lewandowski AJ;Ohuma EO;Holdsworth D;Lamlum H;Woodman MJ;Krasopoulos C;Mills R;McConnell FAK;Wang C;Arthofer C;Lange FJ;Andersson J;Jenkinson M;Antoniades C;Channon KM;Shanmuganathan M;Ferreira VM;Piechnik SK;Klenerman P;Brightling C;Talbot NP;Petousi N;Rahman NM;Ho LP;Saunders K;Geddes JR;Harrison PJ;Pattinson K;Rowland MJ;Angus BJ;Gleeson F;Pavlides M;Koychev I;Miller KL;Mackay C;Jezzard P;Smith SM;Neubauer S
通讯作者：
Neubauer S