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Timely administration of tocilizumab improves outcome of hospitalized COVID-19 patients.
Rutgers, Abraham; Westerweel, Peter E; van der Holt, Bronno; Postma, Simone; van Vonderen, Marit G A; Piersma, Djura P; Postma, Douwe; van den Berge, Maarten; Jong, Eefje; de Vries, Marten; van der Burg, Leonie; Huugen, Dennis; van der Poel, Marjolein; Kampschreur, Linda M; Nijland, Marcel; Strijbos, Jaap H; Tamminga, Menno; Mutsaers, Pim G N J; Schol-Gelok, Suzanne; Dijkstra-Tiekstra, Margriet; Sidorenkov, Grigory; Vincenten, Julien; van Geffen, Wouter H; Knoester, Marjolein; Kosterink, Jos; Gans, Reinold; Stegeman, Coen; Huls, Gerwin; van Meerten, Tom.
Afiliación
  • Rutgers A; Department of Rheumatology and Clinical Immunology, University Medical Center Groningen, Groningen, The Netherlands.
  • Westerweel PE; Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
  • van der Holt B; HOVON Data Center, Department of Haematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
  • Postma S; Department of Haematology, University Medical Center Groningen, Groningen, The Netherlands.
  • van Vonderen MGA; Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
  • Piersma DP; Department of Internal Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.
  • Postma D; Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands.
  • van den Berge M; Department of Pulmonology, University Medical Center Groningen, Groningen, The Netherlands.
  • Jong E; Department of Infectious Diseases, Meander MC, Amersfoort, The Netherlands.
  • de Vries M; Department of Pulmonology, Tjongerschans Hospital, Heerenveen, The Netherlands.
  • van der Burg L; Department of Internal Medicine, Antonius Hospital Sneek, Sneek, The Netherlands.
  • Huugen D; Department of Internal Medicine, Deventer Hospital, Deventer, The Netherlands.
  • van der Poel M; Department of Internal Medicine, Maastricht University Medical Centre+, Maastricht, The Netherlands.
  • Kampschreur LM; Department of Internal Medicine, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
  • Nijland M; Department of Haematology, University Medical Center Groningen, Groningen, The Netherlands.
  • Strijbos JH; Department of Pulmonology, Nij Smellinghe Hospital, Drachten, The Netherlands.
  • Tamminga M; Department of Pulmonology, University Medical Center Groningen, Groningen, The Netherlands.
  • Mutsaers PGNJ; Department of Haematology, Erasmus Medical Center, Rotterdam, The Netherlands.
  • Schol-Gelok S; Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
  • Dijkstra-Tiekstra M; Department of Emergency Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
  • Sidorenkov G; Department of Haematology, University Medical Center Groningen, Groningen, The Netherlands.
  • Vincenten J; Department of Epidemiology, University Medical Center Groningen, Groningen, The Netherlands.
  • van Geffen WH; Department of Pulmonology, Albert Schweitzer Hospital, Dordrecht, The Netherlands.
  • Knoester M; Department of Pulmonology, Medical Center Leeuwarden, Leeuwarden, The Netherlands.
  • Kosterink J; Department of Medical Microbiology, University Medical Center Groningen, Groningen, The Netherlands.
  • Gans R; Pharmacy, University Medical Center Groningen, Groningen, The Netherlands.
  • Stegeman C; Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands.
  • Huls G; Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands.
  • van Meerten T; Department of Haematology, University Medical Center Groningen, Groningen, The Netherlands.
PLoS One ; 17(8): e0271807, 2022.
Article en En | MEDLINE | ID: mdl-35960720
INTRODUCTION: The aim of this study was to determine the efficacy of early tocilizumab treatment for hospitalized patients with COVID-19 disease. METHODS: Open-label randomized phase II clinical trial investigating tocilizumab in patients with proven COVID-19 admitted to the general ward and in need of supplemental oxygen. The primary endpoint of the study was 30-day mortality with a prespecified 2-sided significance level of α = 0.10. A post-hoc analysis was performed for a combined endpoint of mechanical ventilation or death at 30 days. Secondary objectives included comparing the duration of hospital stay, ICU admittance and duration of ICU stay and the duration of mechanical ventilation. RESULTS: A total of 354 patients (67% men; median age 66 years) were enrolled of whom 88% received dexamethasone. Thirty-day mortality was 19% (95% CI 14%-26%) in the standard arm versus 12% (95% CI: 8%-18%) in the tocilizumab arm, hazard ratio (HR) = 0.62 (90% CI 0.39-0.98; p = 0.086). 17% of patients were admitted to the ICU in each arm (p = 0.89). The median stay in the ICU was 14 days (IQR 9-28) in the standard arm versus 9 days (IQR 5-14) in the tocilizumab arm (p = 0.014). Mechanical ventilation or death at thirty days was 31% (95% CI 24%-38%) in the standard arm versus 21% (95% CI 16%-28%) in the tocilizumab arm, HR = 0.65 (95% CI 0.42-0.98; p = 0.042). CONCLUSIONS: This randomized phase II study supports efficacy for tocilizumab when given early in the disease course in hospitalized patients who need oxygen support, especially when concomitantly treated with dexamethasone. TRIAL REGISTRATION: https://www.trialregister.nl/trial/8504.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tratamiento Farmacológico de COVID-19 Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2022 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tratamiento Farmacológico de COVID-19 Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2022 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Estados Unidos