Skip to main content

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).

Publication ,  Journal Article
Bonifácio, LP; Ramacciotti, E; Agati, LB; Vilar, FC; Silva, ACTD; Louzada Júnior, P; Fonseca, BALD; Souza, HCCD; Oliveira, CCCD; Aguiar, VCR ...
Published in: Rev Soc Bras Med Trop
2023

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.

Duke Scholars

Published In

Rev Soc Bras Med Trop

DOI

EISSN

1678-9849

Publication Date

2023

Volume

56

Start / End Page

e0565

Location

Brazil

Related Subject Headings

  • Tropical Medicine
  • Treatment Outcome
  • Standard of Care
  • SARS-CoV-2
  • Prospective Studies
  • Pilot Projects
  • Interleukin-2
  • Interleukin-17
  • Humans
  • Cytokines
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Bonifácio, L. P., Ramacciotti, E., Agati, L. B., Vilar, F. C., Silva, A. C. T. D., Louzada Júnior, P., … Bellissimo-Rodrigues, F. (2023). 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). Rev Soc Bras Med Trop, 56, e0565. https://doi.org/10.1590/0037-8682-0565-2022
Bonifácio, Lívia Pimenta, Eduardo Ramacciotti, Leandro Barile Agati, Fernando Crivelenti Vilar, Anna Christina Tojal da Silva, Paulo Louzada Júnior, Benedito Antônio Lopes da Fonseca, et al. “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).Rev Soc Bras Med Trop 56 (2023): e0565. https://doi.org/10.1590/0037-8682-0565-2022.
Bonifácio LP, Ramacciotti E, Agati LB, Vilar FC, Silva ACTD, Louzada Júnior P, Fonseca BALD, Souza HCCD, Oliveira CCCD, Aguiar VCR, Quadros CADA, Dusilek C, Itinose K, Risson R, Ferreira LRR, Lopes RD, Kallas EG, Bellissimo-Rodrigues F. 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). Rev Soc Bras Med Trop. 2023;56:e0565.

Published In

Rev Soc Bras Med Trop

DOI

EISSN

1678-9849

Publication Date

2023

Volume

56

Start / End Page

e0565

Location

Brazil

Related Subject Headings

  • Tropical Medicine
  • Treatment Outcome
  • Standard of Care
  • SARS-CoV-2
  • Prospective Studies
  • Pilot Projects
  • Interleukin-2
  • Interleukin-17
  • Humans
  • Cytokines