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Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial.
Merchante, Nicolás; Cárcel, Sheila; Garrido-Gracia, José Carlos; Trigo-Rodríguez, Marta; Moreno, María Ángeles Esteban; León-López, Rafael; Espíndola-Gómez, Reinaldo; Alonso, Eduardo Aguilar; García, David Vinuesa; Romero-Palacios, Alberto; Pérez-Camacho, Inés; Gutiérrez-Gutiérrez, Belén; Martínez-Marcos, Francisco Javier; Fernández-Roldán, Concepción; Pérez-Crespo, Pedro María Martínez; Caño, Alexandra Aceituno; León, Eva; Corzo, Juan E; de la Fuente, Carmen; Torre-Cisneros, Julián.
  • Merchante N; Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.
  • Cárcel S; Unidad de Gestión Clínica de Cuidados Intensivos, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), Córdoba, Spain.
  • Garrido-Gracia JC; Unidad de Ensayos Clínicos, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), Córdoba, Spain.
  • Trigo-Rodríguez M; Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.
  • Moreno MÁE; Servicio de Medicina Interna, Hospital Universitario Torrecárdenas, Almería, Spain.
  • León-López R; Unidad de Gestión Clínica de Cuidados Intensivos, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), Córdoba, Spain.
  • Espíndola-Gómez R; Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.
  • Alonso EA; Servicio de Medicina Intensiva, Hospital Infanta Margarita, Córdoba, Spain.
  • García DV; Unidad de Gestión Clínica de Enfermedades Infecciosas, Hospital Universitario Clínico San Cecilio, Granada, Spain.
  • Romero-Palacios A; Unidad de Enfermedades Infecciosas, Hospital Universitario Puerto Real, Instituto de Investigacion Biomédica de Cádiz (INiBICA), Cádiz, Spain.
  • Pérez-Camacho I; Unidad de Gestión Clínica de Enfermedades Infecciosas, Hospital Regional Universitario de Málaga, Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.
  • Gutiérrez-Gutiérrez B; Unidad de Gestión Clínica de Enfermedades Infecciosas, Microbiología y Medicina Preventiva, Hospital Universitario Virgen Macarena, Instituto de Biomedicina de Sevilla (IBIS), Universidad de Sevilla, Sevilla, Spain.
  • Martínez-Marcos FJ; Unidad de Enfermedades Infecciosas, Hospital Universitario Juan Ramón Jiménez, Huelva, Spain.
  • Fernández-Roldán C; Unidad de Enfermedades Infecciosas, Hospital Universitario Virgen de las Nieves, Granada, Spain.
  • Pérez-Crespo PMM; Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.
  • Caño AA; Servicio de Medicina Interna, Hospital Universitario Torrecárdenas, Almería, Spain.
  • León E; Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.
  • Corzo JE; Unidad de Enfermedades Infecciosas y Microbiología, Hospital Universitario de Valmegrid.412800.f, Instituto de Biomedicina de Sevilla (IBiS), Universidad de Sevilla, Sevilla, Spain.
  • de la Fuente C; Unidad de Gestión Clínica de Cuidados Intensivos, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Hospital Universitario Reina Sofía, Universidad de Córdoba (UCO), Córdoba, Spain.
  • Torre-Cisneros J; Servicio de Enfermedades Infecciosas, Hospital Universitario Reina Sofía, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba (UCO), Córdoba, Spain.
Antimicrob Agents Chemother ; 66(2): e0210721, 2022 02 15.
Article in English | MEDLINE | ID: covidwho-1799246
ABSTRACT
The objective of this study was to investigate the efficacy and safety of early treatment with sarilumab, added to standard of care (SOC), in hospitalized adults with COVID-19. Methods included phase II, open-label, randomized, controlled clinical trial of hospitalized patients with COVID-19 pneumonia and interleukin (IL)-6 levels ≥ 40 pg/mL and/or d-dimer > 1,500 ng/mL. Participants were randomized (111) to receive SOC (control group), SOC plus a single subcutaneous dose of sarilumab 200 mg (sarilumab-200 group), or SOC plus a single subcutaneous dose of sarilumab 400 mg (sarilumab-400 group). The primary outcome variable was the development of acute respiratory distress syndrome (ARDS) requiring high-flow nasal oxygenation (HFNO), non-invasive mechanical ventilation (NIMV) or invasive mechanical ventilation (IMV) at day 28. One-hundred and 15 participants (control group, n = 39; sarilumab-200, n = 37; sarilumab-400, n = 39) were included. At randomization, 104 (90%) patients had supplemental oxygen and 103 (90%) received corticosteroids. Eleven (28%) patients in the control group, 10 (27%) in sarilumab-200, and five (13%) in sarilumab-400 developed the primary outcome (hazard ratio [95% CI] of sarilumab-400 vs control group 0.41 [0.14, 1.18]; P = 0.09). Seven (6%) patients died three in the control group and four in sarilumab-200. There were no deaths in sarilumab-400 (P = 0.079, log-rank test for comparisons with the control group). In patients recently hospitalized with COVID-19 pneumonia and features of systemic inflammation, early IL-6 blockade with a single dose of sarilumab 400 mg was safe and associated with a trend for better outcomes. (This study has been registered at ClinicalTrials.gov under identifier NCT04357860.).
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Monoclonal, Humanized / COVID-19 Drug Treatment Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: Antimicrob Agents Chemother Year: 2022 Document Type: Article Affiliation country: Aac.02107-21

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Antibodies, Monoclonal, Humanized / COVID-19 Drug Treatment Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: Antimicrob Agents Chemother Year: 2022 Document Type: Article Affiliation country: Aac.02107-21