Author, as appears in the article.: DiNubile MJ; Parra S; Salomó AC; Levinson SL
Department: Medicina i Cirurgia
URV's Author/s: Castro Salomó, Antoni / Parra Pérez, Sandra
Keywords: Scavenger system Safety Plasma gelsolin Efficacy Covid-19 pneumonia safety plasma gelsolin outcomes efficacy actin
Abstract: 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.
Thematic Areas: Saúde coletiva Oncology Neurology (clinical) Microbiology Medicina ii Medicina i Infectious diseases Immunology Ciências biológicas i
licence for use: https://creativecommons.org/licenses/by/3.0/es/
Author's mail: sandra.parra@urv.cat antoni.castro@urv.cat
Author identifier: 0000-0001-9363-6574 0000-0001-5441-6333
Record's date: 2024-09-07
Papper version: info:eu-repo/semantics/publishedVersion
Licence document URL: https://repositori.urv.cat/ca/proteccio-de-dades/
Papper original source: Open Forum Infectious Diseases. 9 (8): ofac357-ofac357
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
Entity: Universitat Rovira i Virgili
Journal publication year: 2022
Publication Type: Journal Publications
Repositori URV