Autor según el artículo: DiNubile MJ; Parra S; Salomó AC; Levinson SL
Departamento: Medicina i Cirurgia
Autor/es de la URV: Castro Salomó, Antoni / Parra Pérez, Sandra
Palabras clave: Scavenger system Safety Plasma gelsolin Efficacy Covid-19 pneumonia safety plasma gelsolin outcomes efficacy actin
Resumen: Excessive inflammation contributes to the morbidity and mortality of severe coronavirus disease 2019 (COVID-19) pneumonia. Recombinant human plasma gelsolin (rhu-pGSN) improves disease outcomes in diverse experimental models of infectious and noninfectious inflammation.In a blinded, randomized study, 61 subjects with documented COVID-19 pneumonia having a World Health Organization (WHO) Severity Score of 4 to 6 and evidence of a hyperinflammatory state were treated with standard care and either adjunctive rhu-pGSN 12 mg/kg or an equal volume of saline placebo given intravenously at entry, 12 hours, and 36 hours. The prespecified coprimary outcomes were survival without major respiratory, hemodynamic, or renal support on Day 14 and the incidence of serious adverse events (SAEs) during the 90-day study period.All subjects receiving ≥1 dose of study drug were analyzed. Fifty-four of 61 subjects (88.5%) were WHO severity level 4 at entry. The proportions of subjects alive without support on Day 14 were 25 of 30 rhu-pGSN recipients (83.3%) and 27 of 31 placebo recipients (87.1%). Over the duration of the study, WHO Severity Scores improved similarly in both treatment groups. No statistically significant differences were observed between treatment groups at any time point examined. Two subjects died in each group. Numerically fewer subjects in the rhu-pGSN group had SAEs (5 subjects; 16.7%) or ≥ Grade 3 adverse events (5 subjects; 16.7%) than in the placebo group (8 subjects [25.8%] and 9 subjects [29.0%], respectively), mostly involving the lungs. Three rhu-pGSN recipients (10.0%) were intubated compared to 6 placebo recipients (19.4%).Overall, subjects in this study did well irrespective of treatment arm. When added to dexamethasone and remdesivir, no definitive benefit was demonstrated for rhu-pGSN relative to placebo. Safety signals were not identified after the administration of 3 doses of 12 mg/kg rhu-pGSN over 36 hours. The frequencies of SAEs and intubation were numerically fewer in the rhu-pGSN group compared with placebo.© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.
Áreas temáticas: Saúde coletiva Oncology Neurology (clinical) Microbiology Medicina ii Medicina i Infectious diseases Immunology Ciências biológicas i
Acceso a la licencia de uso: https://creativecommons.org/licenses/by/3.0/es/
Direcció de correo del autor: sandra.parra@urv.cat antoni.castro@urv.cat
Identificador del autor: 0000-0001-9363-6574 0000-0001-5441-6333
Fecha de alta del registro: 2024-09-07
Versión del articulo depositado: info:eu-repo/semantics/publishedVersion
URL Documento de licencia: https://repositori.urv.cat/ca/proteccio-de-dades/
Referencia al articulo segun fuente origial: Open Forum Infectious Diseases. 9 (8): ofac357-ofac357
Referencia de l'ítem segons les normes APA: DiNubile MJ; Parra S; Salomó AC; Levinson SL (2022). Adjunctive Recombinant Human Plasma Gelsolin for Severe Coronavirus Disease 2019 Pneumonia. Open Forum Infectious Diseases, 9(8), ofac357-ofac357. DOI: 10.1093/ofid/ofac357
Entidad: Universitat Rovira i Virgili
Año de publicación de la revista: 2022
Tipo de publicación: Journal Publications
Repositori URV