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  • 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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Infectious diseases
Protocol
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
  1. Rafael León López1,2,
  2. Sheila Cárcel Fernández1,2,
  3. Laura Limia Pérez2,3,
  4. Alberto Romero Palacios4,
  5. María Concepción Fernández-Roldán5,
  6. Eduardo Aguilar Alonso6,
  7. Inés Pérez Camacho7,
  8. Jesús Rodriguez-Baño8,9,
  9. Nicolás Merchante10,
  10. Julián Olalla11,
  11. M Ángeles Esteban-Moreno12,
  12. Marta Santos13,
  13. Antonio Luque-Pineda14,15,
  14. Julian Torre-Cisneros2,3
  1. 1Intensive Care Unit, Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain
  2. 2IMIBIC, Cordoba, Andalucía, Spain
  3. 3Internal Medicine Unit, Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain
  4. 4Infectious Diseases Unit, Hospital Universitario de Puerto Real, Puerto Real, Andalucía, Spain
  5. 5Infectious Diseases Unit, Hospital Universitario Virgen de las Nieves, Granada, Andalucía, Spain
  6. 6Intensive Care Unit, Hospital Infanta Margarita, Cabra, Andalucía, Spain
  7. 7Infectious Diseases Unit, Hospital Regional Universitario de Malaga, Malaga, Andalucía, Spain
  8. 8Infectious Diseases Unit, Hospital Universitario Virgen Macarena, Sevilla, Andalucía, Spain
  9. 9Spanish Network for Research in Infectious Diseases, Carlos III Health Institute, Madrid, Comunidad de Madrid, Spain
  10. 10Infectious Diseases and Microbiology Unit, Hospital Universitario Virgen de Valme, Sevilla, Andalucía, Spain
  11. 11Internal Medicine Service, Hospital Costa del Sol, Marbella, Andalucía, Spain
  12. 12Infectious Diseases Unit, Complejo Hospitalario Torrecardenas, Almeria, Andalucía, Spain
  13. 13Infectious Diseases Unit, Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera, Andalucía, Spain
  14. 14Clinical Trials Unit, IMIBIC, Cordoba, Spain
  15. 15Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain
  1. Correspondence to Antonio Luque-Pineda; antonio.luque{at}imibic.org

Abstract

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.

  • adult intensive & critical care
  • infectious diseases
  • internal medicine
  • virology
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2020-039951

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    Footnotes

    • Contributors JT-C, RLL and AL-P collaborate in the design of the protocol and the informed consent form.The protocol was reviewed and agreed with SCF, LLP, ARP, MCF-R, EAA, IPC, JR-B, NM, JO, MAE-M and MS, who contributed in the definition of the eligibility criteria. JT-C contributed in the refinement, final review and approval of the protocol and the informed consent form.

    • Funding COVID-19 Research Programme. Ministry of Health and Families, Regional Government of Andalusia. Project code COVID-0013-2020.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.