Journal article
Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study)
Infectious diseases and therapy, v 10(4), pp 2735-2748
2021
PMID: 34658006
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Introduction
SARS-CoV-2 pneumonia is often associated with hyper-inflammation. The cytokine-storm-like is one of the targets of current therapies for coronavirus disease 2019 (COVID-19). High Interleukin-6 (IL6) blood levels have been identified in severe COVID-19 disease, but there are still uncertainties regarding the actual role of anti-IL6 antagonists in COVID-19 management. Our hypothesis was that the use of sarilumab plus corticosteroids at an early stage of the hyper-inflammatory syndrome would be beneficial and prevent progression to acute respiratory distress syndrome (ARDS).
Methods
We randomly assigned (in a 1:1 ratio) COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive sarilumab plus usual care (experimental group) or usual care alone (control group). Corticosteroids were given to all patients at a 1 mg/kg/day of methylprednisolone for at least 3 days. The primary outcome was the proportion of patients progressing to severe respiratory failure (defined as a score in the Brescia-COVID19 scale ≥ 3) up to day 15.
Results
A total of 201 patients underwent randomization: 99 patients in the sarilumab group and 102 patients in the control group. The rate of patients progressing to severe respiratory failure (Brescia-COVID scale score ≥ 3) up to day 15 was 16.16% in the Sarilumab group versus 15.69% in the control group (RR 1.03; 95% CI 0.48–2.20). No relevant safety issues were identified.
Conclusions
In hospitalized patients with Covid-19 pneumonia, who were under standard oxygen therapy and who presented analytical inflammatory parameters, an early therapeutic intervention with sarilumab plus standard of care (including corticosteroids) was not shown to be more effective than current standard of care alone. The study was registered at EudraCT with number: 2020-002037-15.
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Details
- Title
- Efficacy and Safety of Sarilumab in patients with COVID19 Pneumonia: A Randomized, Phase III Clinical Trial (SARTRE Study)
- Creators
- Aránzazu Sancho-López - Hospital Universitario Puerta de Hierro MajadahondaAntonio F. Caballero-Bermejo - Hospital Universitario Puerta de Hierro MajadahondaBelén Ruiz-Antorán - Hospital Universitario Puerta de Hierro MajadahondaElena Múñez Rubio - Hospital Universitario Puerta de Hierro MajadahondaMercedes García Gasalla - Hospital Universitario Son EspasesJuan Buades - Internal Medicine Department, Hospital Universitari Son LlatzerMarta González Rozas - Internal Medicine Department, Complejo Asistencial de SegoviaMaría López Veloso - Internal Medicine Department, Hospital Universitario BurgosAna Muñoz Gómez - Hospital Universitario Infanta CristinaAna Cuenca Abarca - Internal Medicine Department, Hospital Universitario El EscorialPedro Durán del Campo - Hospital Universitario Puerta de Hierro MajadahondaFátima Ibáñez - Hospital Universitario Puerta de Hierro MajadahondaAlberto Díaz de Santiago - Hospital Universitario Puerta de Hierro MajadahondaYolanda Romero - Hospital Universitario Puerta de Hierro MajadahondaJorge Calderón - Hospital Universitario Puerta de Hierro MajadahondaIlduara Pintos - Hospital Universitario Puerta de Hierro MajadahondaAdrián Ferre Beltrán - Hospital Universitario Son EspasesGustavo Centeno Soto - Hospital Universitario Puerta de Hierro MajadahondaJosé Campos - Hospital Universitario Puerta de Hierro MajadahondaAntonio Ramos Martínez - Hospital Universitario Puerta de Hierro MajadahondaCristina Avendaño-Solá - Hospital Universitario Puerta de Hierro MajadahondaAna Fernández Cruz - Hospital Universitario Puerta de Hierro MajadahondaSARTRE-Study GrpAna P Martinez-Donate - Community Health and Prevention
- Publication Details
- Infectious diseases and therapy, v 10(4), pp 2735-2748
- Publisher
- Springer Healthcare
- Grant note
- Biomedical Research Foundation of the Puerta de Hierro Majadahonda University Hospital Sanofi España (http://dx.doi.org/10.13039/501100013412)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Community Health and Prevention
- Web of Science ID
- WOS:000707831300001
- Scopus ID
- 2-s2.0-85117890897
- Other Identifier
- 991020099179304721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Infectious Diseases