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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
Fisher, Benjamin A Slade, Daniel Rowe, Anna Sharpe, Rowena Thickett, David R Whitehouse, Tony Rowland, Matthew Scriven, James Parekh, Dhruv
Fisher, Benjamin A
Slade, Daniel
Rowe, Anna
Sharpe, Rowena
Thickett, David R
Whitehouse, Tony
Rowland, Matthew
Scriven, James
Parekh, Dhruv
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2021-11-11
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Abstract
Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration numbers EudraCT2020-001684-89, ISRCTN40580903.
Citation
Veenith T, Fisher BA, Slade D, et alCATALYST 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 adultsBMJ Open 2021;11:e050202. doi: 10.1136/bmjopen-2021-050202
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Research Unit
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34764169 (pubmed)
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Journal article
Language
en
Description
© 2021 The Authors. Published by BMJ Publishing. This is an open access article available under a Creative Commons licence.
The published version can be accessed at the following link on the publisher’s website: https://doi.org/10.1136/bmjopen-2021-050202
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ISSN
2044-6055
EISSN
2044-6055
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Sponsors
This trial is supported by the Medical Research Council (MRC) grant number MC_PC_20007. SG is supported by a Senior Investigator Award from the National Institute of Health Research. Staff at the CRCTU are supported by core funding grants from Cancer Research UK (C22436/A25354), the NIHR Biomedical Research Centre (BRC-1215-20009), The Kennedy Trust for Rheumatology Research as part of the Arthritis-Trials Acceleration Programme (KENN161704), and Innovate UK as part of the Midlands-Wales Advanced Therapy Treatment Centres (104232). This paper presents independent research supported by the NIHR Birmingham Biomedical Research Centres at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham, as well as Oxford and University College London Hospitals Biomedical Research Centres. Namilumab is being provided free of charge by Izana Bioscience, Oxford, UK (now part of Roivant). Infliximab is being provided free of charge by Celltrion.
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Licence for published version: Creative Commons Attribution 4.0 International