Efficacy and safety of Ixekizumab vs. low-dose IL-2 vs. Colchicine vs. standard of care in the treatment of patients hospitalized with moderate-to-critical COVID-19: A pilot randomized clinical trial (STRUCK: Survival Trial Using Cytokine Inhibitors)

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Citações na Scopus
3
Tipo de produção
article
Data de publicação
2023
DOI
SciELO
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
SOC BRASILEIRA MEDICINA TROPICAL
Autores
BONIFACIO, Livia Pimenta
RAMACCIOTTI, Eduardo
AGATI, Leandro Barile
VILAR, Fernando Crivelenti
SILVA, Anna Christina Tojal da
LOUZADA JUNIOR, Paulo
FONSECA, Benedito Antonio Lopes da
SOUZA, Hayala Cristina Cavenague de
OLIVEIRA, Caroline Candida Carvalho de
AGUIAR, Valeria Cristina Resende
Citação
REVISTA DA SOCIEDADE BRASILEIRA DE MEDICINA TROPICAL, v.56, article ID e0565-2022, 10p, 2023
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
Background: Cases of coronavirus disease 2019 (COVID-19) requiring hospitalization continue to appear in vulnerable populations, highlighting the importance of novel treatments. The hyperinflammatory response underlies the severity of the disease, and targeting this pathway may be useful. Herein, we tested whether immunomodulation focusing on interleukin (IL)-6, IL-17, and IL-2, could improve the clinical outcomes of patients admitted with COVID-19.Methods: This multicenter, open-label, prospective, randomized controlled trial was conducted in Brazil. Sixty hospitalized patients with moderate-to-critical COVID-19 received in addition to standard of care (SOC): IL-17 inhibitor (ixekizumab 80 mg SC/week) 1 dose every 4 weeks; low-dose IL-2 (1.5 million IU per day) for 7 days or until discharge; or indirect IL-6 inhibitor (colchicine) orally (0.5 mg) every 8 hours for 3 days, followed by 4 weeks at 0.5 mg 2x/day; or SOC alone. The primary outcome was accessed in the ""per protocol"" population as the proportion of patients with clinical improvement, defined as a decrease greater or equal to two points on the World Health Organization's (WHO) seven-category ordinal scale by day 28.Results: All treatments were safe, and the efficacy outcomes did not differ significantly from those of SOC. Interestingly, in the colchicine group, all participants had an improvement of greater or equal to two points on the WHO seven-category ordinal scale and no deaths or patient deterioration were observed.Conclusions: Ixekizumab, colchicine, and IL-2 were demonstrated to be safe but ineffective for COVID-19 treatment. These results must be interpreted cautiously because of the limited sample size.
Palavras-chave
COVID-19, SARS-CoV-2, Cytokine storm, Ixekizumab, Interleukin-2, Colchicine
URI
https://observatorio.fm.usp.br/handle/OPI/54695
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Coleções
Artigos e Materiais de Revistas Científicas - FM/MIP
Artigos e Materiais de Revistas Científicas - COVID-19
Artigos e Materiais de Revistas Científicas - LIM/60