دورية أكاديمية
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).
| العنوان: | 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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| المؤلفون: | Bonifácio LP; Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil., Ramacciotti E; Science Valley Research Institute, São Paulo, SP, Brasil.; Grupo Leforte, Hospital e Maternidade Christóvão da Gama, Santo André, SP, Brasil., Agati LB, Vilar FC; Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil., Silva ACTD; Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil., Louzada Júnior P; Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil., Fonseca BALD; Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil., Souza HCC; Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil., Oliveira CCC; Science Valley Research Institute, São Paulo, SP, Brasil.; Grupo Leforte, Hospital e Maternidade Christóvão da Gama, Santo André, SP, Brasil., Aguiar VCR; Science Valley Research Institute, São Paulo, SP, Brasil.; Grupo Leforte, Hospital e Maternidade Christóvão da Gama, Santo André, SP, Brasil., Quadros CAA; Grupo Leforte, Hospital e Maternidade Christóvão da Gama, Santo André, SP, Brasil., Dusilek C; Hospital do Rocio, Campo Largo, PR, Brasil., Itinose K; Hospital do Rocio, Campo Largo, PR, Brasil., Risson R; Hospital do Rocio, Campo Largo, PR, Brasil., Ferreira LRR; Hospital do Rocio, Campo Largo, PR, Brasil., Lopes RD; Brazilian Clinical Research Institute, São Paulo, SP, Brasil.; Duke University Medical Center - Duke Clinical Research Institute, Durham, North Carolina, USA., Kallas EG; Universidade de São Paulo, Faculdade de Medicina, Departamento de Moléstias Infecciosas e Parasitárias, São Paulo, SP, Brasil., Bellissimo-Rodrigues F; Universidade de São Paulo, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, SP, Brasil. |
| المصدر: | Revista da Sociedade Brasileira de Medicina Tropical [Rev Soc Bras Med Trop] 2023 Apr 14; Vol. 56, pp. e0565. Date of Electronic Publication: 2023 Apr 14 (Print Publication: 2023). |
| نوع المنشور: | Randomized Controlled Trial; Multicenter Study; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Sociedade Brasileira de Medicina Tropical Country of Publication: Brazil NLM ID: 7507456 Publication Model: eCollection Cited Medium: Internet ISSN: 1678-9849 (Electronic) Linking ISSN: 00378682 NLM ISO Abbreviation: Rev Soc Bras Med Trop Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <1997-> : Uberaba, MG, Brazil : Sociedade Brasileira de Medicina Tropical Original Publication: Rio De Janeiro : Sociedade Brasileira De Medicina Tropical |
| مواضيع طبية MeSH: | COVID-19*, Humans ; Interleukin-17 ; Interleukin-2 ; SARS-CoV-2 ; Colchicine/adverse effects ; Cytokines ; COVID-19 Drug Treatment ; Prospective Studies ; Pilot Projects ; Standard of Care ; Treatment Outcome |
| مستخلص: | 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. |
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| المشرفين على المادة: | BTY153760O (ixekizumab) 0 (Interleukin-17) 0 (Interleukin-2) SML2Y3J35T (Colchicine) 0 (Cytokines) |
| تواريخ الأحداث: | Date Created: 20230419 Date Completed: 20230421 Latest Revision: 20230422 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC10109354 |
| DOI: | 10.1590/0037-8682-0565-2022 |
| PMID: | 37075454 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1678-9849 |
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| DOI: | 10.1590/0037-8682-0565-2022 |