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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.
León López, Rafael; Fernández, Sheila Cárcel; Limia Pérez, Laura; Romero Palacios, Alberto; Fernández-Roldán, María Concepción; Aguilar Alonso, Eduardo; Pérez Camacho, Inés; Rodriguez-Baño, Jesús; Merchante, Nicolás; Olalla, Julián; Esteban-Moreno, M Ángeles; Santos, Marta; Luque-Pineda, Antonio; Torre-Cisneros, Julian.
  • León López R; Intensive Care Unit, Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain.
  • Fernández SC; IMIBIC, Cordoba, Andalucía, Spain.
  • Limia Pérez L; Intensive Care Unit, Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain.
  • Romero Palacios A; IMIBIC, Cordoba, Andalucía, Spain.
  • Fernández-Roldán MC; IMIBIC, Cordoba, Andalucía, Spain.
  • Aguilar Alonso E; Internal Medicine Unit, Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain.
  • Pérez Camacho I; Infectious Diseases Unit, Hospital Universitario de Puerto Real, Puerto Real, Andalucía, Spain.
  • Rodriguez-Baño J; Infectious Diseases Unit, Hospital Universitario Virgen de las Nieves, Granada, Andalucía, Spain.
  • Merchante N; Intensive Care Unit, Hospital Infanta Margarita, Cabra, Andalucía, Spain.
  • Olalla J; Infectious Diseases Unit, Hospital Regional Universitario de Malaga, Malaga, Andalucía, Spain.
  • Esteban-Moreno MÁ; Infectious Diseases Unit, Hospital Universitario Virgen Macarena, Sevilla, Andalucía, Spain.
  • Santos M; Spanish Network for Research in Infectious Diseases, Carlos III Health Institute, Madrid, Comunidad de Madrid, Spain.
  • Luque-Pineda A; Infectious Diseases and Microbiology Unit, Hospital Universitario Virgen de Valme, Sevilla, Andalucía, Spain.
  • Torre-Cisneros J; Internal Medicine Service, Hospital Costa del Sol, Marbella, Andalucía, Spain.
BMJ Open ; 10(11): e039951, 2020 11 14.
Article in English | MEDLINE | ID: covidwho-944946
Semantic information from SemMedBD (by NLM)
1. sarilumab TREATS Cytokine Release Syndrome
Subject
sarilumab
Predicate
TREATS
Object
Cytokine Release Syndrome
2. Cytokine Release Syndrome PROCESS_OF Adult
Subject
Cytokine Release Syndrome
Predicate
PROCESS_OF
Object
Adult
3. sarilumab TREATS Adult
Subject
sarilumab
Predicate
TREATS
Object
Adult
4. Respiratory Distress Syndrom PROCESS_OF C0030705
Subject
Respiratory Distress Syndrom
Predicate
PROCESS_OF
Object
C0030705
5. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
6. Inhibitor PART_OF Interleukin 6 Receptor
Subject
Inhibitor
Predicate
PART_OF
Object
Interleukin 6 Receptor
7. sarilumab TREATS COVID-19
Subject
sarilumab
Predicate
TREATS
Object
COVID-19
8. sarilumab TREATS Patients
Subject
sarilumab
Predicate
TREATS
Object
Patients
9. interleukin-6 PREVENTS Respiratory Distress Syndrom
Subject
interleukin-6
Predicate
PREVENTS
Object
Respiratory Distress Syndrom
10. Fibrin fragment D PREVENTS Respiratory Distress Syndrom
Subject
Fibrin fragment D
Predicate
PREVENTS
Object
Respiratory Distress Syndrom
11. Cytokine Release Syndrome PROCESS_OF Patients
Subject
Cytokine Release Syndrome
Predicate
PROCESS_OF
Object
Patients
12. sarilumab TREATS Cytokine Release Syndrome
Subject
sarilumab
Predicate
TREATS
Object
Cytokine Release Syndrome
13. Cytokine Release Syndrome PROCESS_OF Adult
Subject
Cytokine Release Syndrome
Predicate
PROCESS_OF
Object
Adult
14. sarilumab TREATS Adult
Subject
sarilumab
Predicate
TREATS
Object
Adult
15. Respiratory Distress Syndrome, Adult PROCESS_OF Patients
Subject
Respiratory Distress Syndrome, Adult
Predicate
PROCESS_OF
Object
Patients
16. COVID-19 PROCESS_OF Patients
Subject
COVID-19
Predicate
PROCESS_OF
Object
Patients
17. Inhibitor PART_OF Interleukin 6 Receptor
Subject
Inhibitor
Predicate
PART_OF
Object
Interleukin 6 Receptor
18. sarilumab TREATS COVID-19
Subject
sarilumab
Predicate
TREATS
Object
COVID-19
19. sarilumab TREATS Patients
Subject
sarilumab
Predicate
TREATS
Object
Patients
20. interleukin-6 PREVENTS Respiratory Distress Syndrome, Adult
Subject
interleukin-6
Predicate
PREVENTS
Object
Respiratory Distress Syndrome, Adult
21. Fibrin fragment D PREVENTS Respiratory Distress Syndrome, Adult
Subject
Fibrin fragment D
Predicate
PREVENTS
Object
Respiratory Distress Syndrome, Adult
22. Cytokine Release Syndrome PROCESS_OF Patients
Subject
Cytokine Release Syndrome
Predicate
PROCESS_OF
Object
Patients
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.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Respiratory Distress Syndrome / Coronavirus Infections / Antibodies, Monoclonal, Humanized / Cytokine Release Syndrome Type of study: Controlled clinical trial / Clinical Practice Guide / Observational study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: BMJ Open Year: 2020 Document Type: Article Affiliation country: Bmjopen-2020-039951

Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Respiratory Distress Syndrome / Coronavirus Infections / Antibodies, Monoclonal, Humanized / Cytokine Release Syndrome Type of study: Controlled clinical trial / Clinical Practice Guide / Observational study / Randomized controlled trials Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: BMJ Open Year: 2020 Document Type: Article Affiliation country: Bmjopen-2020-039951