Efficacy and safety of Ixekizumab vs. low-dose IL-2 vs. Colchicine vs. standard of care on the treatment of patients hospitalized with moderate to critical Covid-19: a pilot randomized clinical trial (STRUCK: Survival Trial Using Cytokine Inhibitors)
Pimenta Bonifácio et al.,
Efficacy and safety of Ixekizumab vs. low-dose IL-2 vs. Colchicine vs. standard of care on the treatment of..,
SSRN Electronic Journal, doi:10.2139/ssrn.4095747, NCT04724629
Open label RCT late stage hospitalized patients in Brazil with 14 colchicine and 16 SOC patients, showing lower mortality and improved recovery with treatment, without statistical significance. Authors note that the colchicine group had one patient with SOFA ≥7 vs. zero for SOC, however both groups had one patient intubated and SOC had more patients not requiring high-flow oxygen (12 vs. 8).
risk of death, 78.9% lower, RR 0.21, p = 0.49, treatment 0 of 14 (0.0%), control 2 of 16 (12.5%), NNT 8.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of no improvement, 84.9% lower, RR 0.15, p = 0.23, treatment 0 of 14 (0.0%), control 3 of 16 (18.8%), NNT 5.3, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Pimenta Bonifácio et al., 28 Apr 2022, Randomized Controlled Trial, Brazil, peer-reviewed, 20 authors, dosage 1.5mg days 1-3, 1mg days 4-28, trial
NCT04724629 (history).
Contact:
fbellissimo@usp.br, livia_pb@usp.br.
Abstract: pe
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Efficacy and safety of Ixekizumab vs. low-dose IL-2 vs. Colchicine vs. standard of care
on the treatment of patients hospitalized with moderate to critical Covid-19: a pilot
randomized clinical trial (STRUCK: Survival Trial Using Cytokine Inhibitors)
Running title: Exploring new targets for Covid-19 treatment
Lívia Pimenta Bonifácio, Ph.D.,1* Eduardo Ramacciotti, Ph.D.,2,3* Leandro Barile Agati*,
Ph.D.,2,3 Fernando Crivelenti Vilar, Ph.D,1 Anna Christina Tojal da Silva, MD.,1 Paulo
Louzada Júnior, Ph.D.,1 Benedito Antônio Lopes da Fonseca, Ph.D.,1 Hayala Cristina
Cavenague de Souza, Ph.D.,1 Caroline Candida Carvalho de Oliveira, MD.,2,3 Valéria Cristina
Resende Aguiar, MD., 2,3 Carlos Augusto de Aguiar Quadros, MD., 3 Cesar Dusilek, MD.,4
Kenji Itinose, MD.,4 Ricardo Gustavo Zill Risson, MD.,4 Lucas Roberto Rivabem Ferreira,
MD.,4 Rogério Aparecido Dedivitis, Ph.D.,5 André Sementilli Cortina, MD.,5 Renato Delascio
Lopes, Ph.D.,6,7 Esper Georges Kallas, Ph.D.,8 and Fernando Bellissimo-Rodrigues, Ph.D.1
*contributed equally to the present study
1Ribeirão Preto Medical School, University of São Paulo - FMRP / USP. Ribeirão Preto. São
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Paulo. Brazil
2Science Valley Research Institute, São Paulo, SP, Brazil
3Hospital e Maternidade Christóvão da Gama, Grupo Leforte, Santo André, SP, Brazil
4Hospital do Rocio, Campo Largo, Paraná, Brazil
5Irmandade da Santa Casa da Misericórdia de Santos, São Paulo, Brazil
6 Brazilian Clinical Research Institute, São Paulo, SP, Brazil
7Duke University Medical Center – Duke Clinical Research Institute, Durham, North Carolina.
8 Department of Infectious and Parasitic Diseases, School of Medicine, University of São
Paulo, SP, Brazil
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Corresponding Author: Fernando Bellissimo-Rodrigues
Social Medicine Department, Ribeirão Preto Medical School (USP)
Campus Universitário, Monte Alegre 14048-900, Ribeirão Preto, São Paulo, Brazil
Phone: (+5516) 3602-2536
Email: fbellissimo@usp.br
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Lívia Pimenta Bonifácio
Social Medicine Department, Ribeirão Preto Medical School (USP)
Campus Universitário, Monte Alegre 14048-900, Ribeirão Preto, São Paulo, Brazil
Phone: (+5516) 3602-2536
Email: livia_pb@usp.br
This preprint research paper has not been peer reviewed. Electronic copy available at: https://ssrn.com/abstract=4095747
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ABSTRACT
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Background: To evaluate the efficacy and safety of Ixekizumab (IL-17 inhibitor), or low-dose
IL-2 or colchicine on top of standard of care (SOC) for Covid-19 treatment.
Methods: A multicenter, open-label, randomized, adaptive study of 4 treatment arms
conducted in Brazil. Hospitalized patients with moderate to critical Covid-19 were enrolled
according to predetermined eligibility criteria. Patients were randomized to one of 4 arms:
standard of care (SOC) alone or combined with Ixekizumab, or low-dose IL-2 or colchicine.
The primary efficacy outcome was accessed in the “per protocol” population as the proportion
of patients with clinical improvement, defined as a two-point decrease on the WHO sevencategory ordinal scale at day 28 after randomization.
Findings: 60 patients were enrolled in the study: 16 in the SOC group, 16 in the Ixekizumab
group, 14 in the low-dose IL-2 group, and 14 in the colchicine group. Patients assigned to the
colchicine arm presented the greatest improvement in the WHO scale (100%) by day 28, while
those in the low dose IL-2 had the worse improvement (64.3%). The colchicine arm presented
the..
Late treatment
is less effective
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