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http://hdl.handle.net/2445/184279
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DC Field | Value | Language |
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dc.contributor.author | Tom, Jennifer | - |
dc.contributor.author | Bao, Min | - |
dc.contributor.author | Tsai, Larry | - |
dc.contributor.author | Qamra, Aditi | - |
dc.contributor.author | Summers, David | - |
dc.contributor.author | Carrasco Triguero, Montserrat | - |
dc.contributor.author | Mcbride, Jacqueline | - |
dc.contributor.author | Rosenberger, Carrie M. | - |
dc.contributor.author | Lin, Celia J. F. | - |
dc.contributor.author | Stubbings, William | - |
dc.contributor.author | Blyth, Kevin G. | - |
dc.contributor.author | Carratalà, Jordi | - |
dc.contributor.author | François, Bruno | - |
dc.contributor.author | Benfield, Thomas | - |
dc.contributor.author | Haslem, Derrick | - |
dc.contributor.author | Bonfanti, Paolo | - |
dc.contributor.author | Van der Leest, Cor H. | - |
dc.contributor.author | Rohatgi, Nidhi | - |
dc.contributor.author | Wiese, Lothar | - |
dc.contributor.author | Luyt, Charles Edouard | - |
dc.contributor.author | Kheradmand, Farrah | - |
dc.contributor.author | Rosas, Ivan O. | - |
dc.contributor.author | Cai, Fang | - |
dc.date.accessioned | 2022-03-22T10:33:19Z | - |
dc.date.available | 2022-03-22T10:33:19Z | - |
dc.date.issued | 2021-10-12 | - |
dc.identifier.issn | 1530-0293 | - |
dc.identifier.uri | http://hdl.handle.net/2445/184279 | - |
dc.description.abstract | OBJECTIVES: To explore candidate prognostic and predictive biomarkers identified in retrospective observational studies (interleukin-6, C-reactive protein, lactate dehydrogenase, ferritin, lymphocytes, monocytes, neutrophils, d-dimer, and platelets) in patients with coronavirus disease 2019 pneumonia after treatment with tocilizumab, an anti-interleukin-6 receptor antibody, using data from the COVACTA trial in patients hospitalized with severe coronavirus disease 2019 pneumonia. DESIGN: Exploratory analysis from a multicenter, randomized, double-blind, placebo-controlled, phase 3 trial. SETTING: Hospitals in North America and Europe. PATIENTS: Adults hospitalized with severe coronavirus disease 2019 pneumonia receiving standard care. INTERVENTION: Randomly assigned 2:1 to IV tocilizumab 8 mg/kg or placebo. MEASUREMENTS AND MAIN RESULTS: Candidate biomarkers were measured in 295 patients in the tocilizumab arm and 142 patients in the placebo arm. Efficacy outcomes assessed were clinical status on a seven-category ordinal scale (1, discharge; 7, death), mortality, time to hospital discharge, and mechanical ventilation (if not receiving it at randomization) through day 28. Prognostic and predictive biomarkers were evaluated continuously with proportional odds, binomial or Fine-Gray models, and additional sensitivity analyses. Modeling in the placebo arm showed all candidate biomarkers except lactate dehydrogenase and d-dimer were strongly prognostic for day 28 clinical outcomes of mortality, mechanical ventilation, clinical status, and time to hospital discharge. Modeling in the tocilizumab arm showed a predictive value of ferritin for day 28 clinical outcomes of mortality (predictive interaction, p = 0.03), mechanical ventilation (predictive interaction, p = 0.01), and clinical status (predictive interaction, p = 0.02) compared with placebo. CONCLUSIONS: Multiple biomarkers prognostic for clinical outcomes were confirmed in COVACTA. Ferritin was identified as a predictive biomarker for the effects of tocilizumab in the COVACTA patient population; high ferritin levels were associated with better clinical outcomes for tocilizumab compared with placebo at day 28. | - |
dc.format.extent | 11 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Ovid Technologies (Wolters Kluwer Health) | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1097/CCM.0000000000005229 | - |
dc.relation.ispartof | Critical Care Medicine, 2021, vol 50, num 3, p. 398-409 | - |
dc.relation.uri | https://doi.org/10.1097/CCM.0000000000005229 | - |
dc.rights | cc by-nc-nd (c) Tom, Jennifer et al, 2022 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | COVID-19 | - |
dc.subject.classification | Marcadors bioquímics | - |
dc.subject.other | COVID-19 | - |
dc.subject.other | Biochemical markers | - |
dc.title | Prognostic and Predictive Biomarkers in Patients With Coronavirus Disease 2019 Treated With Tocilizumab in a Randomized Controlled Trial | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2022-03-22T10:23:24Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 34612846 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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File | Description | Size | Format | |
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Prognostic_and_Predictive_Biomarkers_in_Patients.pdf | 2.05 MB | Adobe PDF | View/Open |
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