Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial

León, Rafael; Cárcel Fernández, Sheila; Limia Pérez, Laura; Romero Palacios, Alberto; Fernández-Roldán, Concepción; Aguilar Alonso, Eduardo; Pérez-Camacho, Inés; Rodríguez-Baño, Jesús; Merchante, Nicolás; Olalla, Julián; Esteban-Moreno, M. Ángeles; Santos, Marta; Luque-Pineda, Antonio; Torre-Cisneros, Julián

Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial

[Introduction] About 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inh...

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Autores:	León, Rafael, Cárcel Fernández, Sheila, Limia Pérez, Laura, Romero Palacios, Alberto, Fernández-Roldán, Concepción, Aguilar Alonso, Eduardo, Pérez-Camacho, Inés, Rodríguez-Baño, Jesús, Merchante, Nicolás, Olalla, Julián, Esteban-Moreno, M. Ángeles, Santos, Marta, Luque-Pineda, Antonio, Torre-Cisneros, Julián
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2020
País:	España
Institución:	Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:	DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:	oai:digital.csic.es:10261/236490
Acceso en línea:	http://hdl.handle.net/10261/236490
Access Level:	acceso abierto

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spelling	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trialLeón, RafaelCárcel Fernández, SheilaLimia Pérez, LauraRomero Palacios, AlbertoFernández-Roldán, ConcepciónAguilar Alonso, EduardoPérez-Camacho, InésRodríguez-Baño, JesúsMerchante, NicolásOlalla, JuliánEsteban-Moreno, M. ÁngelesSantos, MartaLuque-Pineda, AntonioTorre-Cisneros, Julián[Introduction] About 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive).[Methods and analysis] Phase II, open-label, randomised, multicentre, controlled clinical trial to study the efficacy and safety of the administration of two doses of sarilumab (200 and 400 mg) plus best available therapy (BAT) in hospitalised adults with COVID-19 presenting cytokine release syndrome. This strategy will be compared with a BAT control group. The efficacy and safety will be monitored up to 28 days postadministration. A total of 120 patients will be recruited (40 patients in each arm).[Ethics and dissemination] The clinical trial has been approved by the Research Ethics Committee of the coordinating centre and authorised by the Spanish Agency of Medicines and Medical Products. If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions.[Trial registration number] NCT04357860.COVID-19 Research Programme. Ministry of Health and Families, Regional Government of Andalusia. Project code COVID-0013-2020.BMJ Publishing GroupJunta de AndalucíaConsejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]2021202120202021info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10261/236490reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Ingléshttp://doi.org/10.1136/bmjopen-2020-039951Síinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/2364902026-05-22T06:33:51Z
dc.title.none.fl_str_mv	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial
title	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial
spellingShingle	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial León, Rafael
title_short	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial
title_full	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial
title_fullStr	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial
title_full_unstemmed	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial
title_sort	Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial
dc.creator.none.fl_str_mv	León, Rafael Cárcel Fernández, Sheila Limia Pérez, Laura Romero Palacios, Alberto Fernández-Roldán, Concepción Aguilar Alonso, Eduardo Pérez-Camacho, Inés Rodríguez-Baño, Jesús Merchante, Nicolás Olalla, Julián Esteban-Moreno, M. Ángeles Santos, Marta Luque-Pineda, Antonio Torre-Cisneros, Julián
author	León, Rafael
author_facet	León, Rafael Cárcel Fernández, Sheila Limia Pérez, Laura Romero Palacios, Alberto Fernández-Roldán, Concepción Aguilar Alonso, Eduardo Pérez-Camacho, Inés Rodríguez-Baño, Jesús Merchante, Nicolás Olalla, Julián Esteban-Moreno, M. Ángeles Santos, Marta Luque-Pineda, Antonio Torre-Cisneros, Julián
author_role	author
author2	Cárcel Fernández, Sheila Limia Pérez, Laura Romero Palacios, Alberto Fernández-Roldán, Concepción Aguilar Alonso, Eduardo Pérez-Camacho, Inés Rodríguez-Baño, Jesús Merchante, Nicolás Olalla, Julián Esteban-Moreno, M. Ángeles Santos, Marta Luque-Pineda, Antonio Torre-Cisneros, Julián
author2_role	author author author author author author author author author author author author author
dc.contributor.none.fl_str_mv	Junta de Andalucía Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
description	[Introduction] About 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive).
publishDate	2020
dc.date.none.fl_str_mv	2020 2021 2021 2021
dc.type.none.fl_str_mv	info:eu-repo/semantics/article http://purl.org/coar/resource_type/c_6501 Publisher's version info:eu-repo/semantics/publishedVersion
format	article
status_str	publishedVersion
dc.identifier.none.fl_str_mv	http://hdl.handle.net/10261/236490
url	http://hdl.handle.net/10261/236490
dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.relation.none.fl_str_mv	http://doi.org/10.1136/bmjopen-2020-039951 Sí
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	BMJ Publishing Group
publisher.none.fl_str_mv	BMJ Publishing Group
dc.source.none.fl_str_mv	reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str	Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str	DIGITAL.CSIC. Repositorio Institucional del CSIC
collection	DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score	15.812455

Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial

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