دورية أكاديمية
Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial
| العنوان: | Efficacy and safety of baricitinib in hospitalized adults with severe or critical COVID-19 (Bari-SolidAct): a randomised, double-blind, placebo-controlled phase 3 trial |
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| المؤلفون: | Trøseid, Marius, Arribas, José Ramón, Assoumou, Lambert, Holten, Aleksander Rygh, Poissy, Julien, Terzić, Vida, Mazzaferri, Fulvia, Rodríguez-Baño, Jesús, Eustace, Joe, Hites, Maya, Joannidis, Michael, Paiva, Jose‑Artur, Reuter, Jean, Püntmann, Isabel, Patrick-Brown, Thale D. J. H., Westerheim, Elin, Nezvalova-Henriksen, Katerina, Beniguel, Lydie, Dahl, Tuva Børresdatter, Bouscambert, Maude, Halanova, Monika, Péterfi, Zoltán, Tsiodras, Sotirios, Rezek, Michael, Briel, Matthias, Ünal, Serhat, Schlegel, Martin, Ader, Florence, Lacombe, Karine, Amdal, Cecilie Delphin, Rodrigues, Serge, Tonby, Kristian, Gaudet, Alexandre, Heggelund, Lars, Mootien, Joy, Johannessen, Asgeir, Møller, Jannicke Horjen, Díaz-Pollán, Beatriz, Tveita, Anders Aune, Kildal, Anders Benjamin, Richard, Jean-Christophe, Dalgard, Olav, Simensen, Victoria Charlotte, Baldé, Aliou, Gastines, Lucie de, Álamo, Marta del, Aydin, Burç, Lund-Johansen, Fridtjof, Trabaud, Mary-Anne, Diallo, Alpha, Halvorsen, Bente, Røttingen, John-Arne, Tacconelli, Evelina, Yazdanpanah, Yazdan, Olsen, Inge C., Costagliola, Dominique, EU SolidAct study group |
| المساهمون: | European Commission |
| بيانات النشر: | BioMed Central Springer Nature |
| سنة النشر: | 2023 |
| المجموعة: | Digital.CSIC (Consejo Superior de Investigaciones Científicas / Spanish National Research Council) |
| مصطلحات موضوعية: | COVID-19, Vaccination, Safety, Baricitinib |
| الوصف: | © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0Test/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0Test/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. ; [Background] Baricitinib has shown efficacy in hospitalized patients with COVID-19, but no placebo-controlled trials have focused specifically on severe/critical COVID, including vaccinated participants. ; [Methods] Bari-SolidAct is a phase-3, multicentre, randomised, double-blind, placebo-controlled trial, enrolling participants from June 3, 2021 to March 7, 2022, stopped prematurely for external evidence. Patients with severe/critical COVID-19 were randomised to Baricitinib 4 mg once daily or placebo, added to standard of care. The primary endpoint was all-cause mortality within 60 days. Participants were remotely followed to day 90 for safety and patient related outcome measures. ; [Results] Two hundred ninety-nine patients were screened, 284 randomised, and 275 received study drug or placebo and were included in the modified intent-to-treat analyses (139 receiving baricitinib and 136 placebo). Median age was 60 (IQR 49–69) years, 77% were male ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1364-8535 |
| العلاقة: | #PLACEHOLDER_PARENT_METADATA_VALUE#; info:eu-repo/grantAgreement/EC/H2020/101015736; Publisher's version; https://doi.org/10.1186/s13054-022-04205-8Test; Sí; Critical Care 27: 9 (2023); http://hdl.handle.net/10261/353596Test |
| DOI: | 10.1186/s13054-022-04205-8 |
| الإتاحة: | https://doi.org/10.1186/s13054-022-04205-8Test http://hdl.handle.net/10261/353596Test |
| حقوق: | open |
| رقم الانضمام: | edsbas.B1D33279 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 13648535 |
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| DOI: | 10.1186/s13054-022-04205-8 |