Birmingham Acute Care Research Group, Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
Department of Critical Care Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
BMJ Open. 2021 Nov 11;11(11):e050202. doi: 10.1136/bmjopen-2021-050202.
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.
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，促进有害的、促炎的后果。免疫调节因此是一种有吸引力的治疗策略，我们试图测试已获许可和新型候选药物。
CATALYST 试验是一项多臂、开放标签、多中心、二期平台试验，旨在确定候选新型治疗方法，与常规治疗相比，改善 COVID-19 住院患者的结局。具有生物标志物改善证据的治疗方法将被提出用于当前全国性三期平台试验的更大规模测试。年龄>16 岁、临床表现强烈提示 SARS-CoV-2 肺炎（胸部 X 光或 CT 扫描阳性，或伴有阳性逆转录 PCR 检测）且 C 反应蛋白（CRP）≥40mg/L 的住院患者符合条件。主要结局指标是从入院到第 14 天、出院或死亡时连续测量的 CRP。次要结局指标包括 WHO 临床进展改善量表作为主要疗效评估。
该方案得到了东米德兰兹-诺丁汉 2 研究伦理委员会（20/EM/0115）的批准，并被赋予了紧急公共卫生状态；最初的批准于 2020 年 5 月 5 日获得，当前方案版本（V.6.0）于 2020 年 10 月 12 日获得批准。英国药品和保健产品监管局（MHRA）也批准了所有方案版本。该试验的结果将通过国家和国际演讲和同行评议出版物传播。
EudraCT2020-001684-89，ISRCTN40580903。
