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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)

Pimenta Bonifácio et al., Revista da Sociedade Brasileira de Medicina Tropical, doi:10.1590/0037-8682-0565-2022, STRUCK, NCT04724629, Apr 2022 (preprint)
https://c19early.org/pimentabonifacio2ixe.html
Mortality -50% Improvement Relative Risk Improvement 0% Ixekizumab  STRUCK  LATE TREATMENT  RCT Is late treatment with ixekizumab beneficial for COVID-19? RCT 32 patients in Brazil (January - July 2021) Trial underpowered to detect differences c19early.org Pimenta Bonifácio et al., Revista da S.., Apr 2022 Favorsixekizumab Favorscontrol 0 0.5 1 1.5 2+
Open label RCT late stage hospitalized patients in Brazil showing no significant difference with IL-2 or ixekizumab treatment. Mortality was lower and recovery was greater with colchicine, without statistical significance.
Study covers interleukin-2, ixekizumab, and colchicine.
risk of death, 50.0% higher, RR 1.50, p = 1.00, treatment 3 of 16 (18.8%), control 2 of 16 (12.5%).
risk of no improvement, no change, RR 1.00, p = 1.00, treatment 3 of 16 (18.8%), control 3 of 16 (18.8%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Pimenta Bonifácio et al., 28 Apr 2022, Randomized Controlled Trial, Brazil, peer-reviewed, mean age 48.9, 18 authors, study period 6 January, 2021 - 9 July, 2021, trial NCT04724629 (history) (STRUCK). Contact: fbellissimo@usp.br, livia_pb@usp.br.
DOI record: { "DOI": "10.1590/0037-8682-0565-2022", "ISSN": [ "1678-9849", "0037-8682" ], "URL": "http://dx.doi.org/10.1590/0037-8682-0565-2022", "alternative-id": [ "S0037-86822023000100317" ], "author": [ { "ORCID": "http://orcid.org/0000-0002-4309-0304", "affiliation": [ { "name": "Universidade de São Paulo, Brasil" } ], "authenticated-orcid": false, "family": "Bonifácio", "given": "Lívia Pimenta", "sequence": "first" }, { "ORCID": "http://orcid.org/0000-0002-5735-1333", "affiliation": [ { "name": "Science Valley Research Institute, Brasil; Grupo Leforte, Brasil" } ], "authenticated-orcid": false, "family": "Ramacciotti", "given": "Eduardo", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0001-9655-4734", "affiliation": [], "authenticated-orcid": false, "family": "Agati", "given": "Leandro Barile", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0001-8232-5375", "affiliation": [ { "name": "Universidade de São Paulo, Brasil" } ], "authenticated-orcid": false, "family": "Vilar", "given": "Fernando Crivelenti", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0001-8672-4453", "affiliation": [ { "name": "Universidade de São Paulo, Brasil" } ], "authenticated-orcid": false, "family": "Silva", "given": "Anna Christina Tojal da", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0003-2585-3870", "affiliation": [ { "name": "Universidade de São Paulo, Brasil" } ], "authenticated-orcid": false, "family": "Louzada Júnior", "given": "Paulo", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0003-3159-5687", "affiliation": [ { "name": "Universidade de São Paulo, Brasil" } ], "authenticated-orcid": false, "family": "Fonseca", "given": "Benedito Antônio Lopes da", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0002-7970-5403", "affiliation": [ { "name": "Universidade de São Paulo, Brasil" } ], "authenticated-orcid": false, "family": "Souza", "given": "Hayala Cristina Cavenague de", "sequence": "additional" }, { "ORCID": "http://orcid.org/0009-0005-3588-3370", "affiliation": [ { "name": "Science Valley Research Institute, Brasil; Grupo Leforte, Brasil" } ], "authenticated-orcid": false, "family": "Oliveira", "given": "Caroline Candida Carvalho de", "sequence": "additional" }, { "ORCID": "http://orcid.org/0009-0004-9950-0415", "affiliation": [ { "name": "Science Valley Research Institute, Brasil; Grupo Leforte, Brasil" } ], "authenticated-orcid": false, "family": "Aguiar", "given": "Valéria Cristina Resende", "sequence": "additional" }, { "ORCID": "http://orcid.org/0009-0006-2098-0706", "affiliation": [ { "name": "Grupo Leforte, Brasil" } ], "authenticated-orcid": false, "family": "Quadros", "given": "Carlos Augusto de Aguiar", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0002-6243-8855", "affiliation": [ { "name": "Hospital do Rocio, Brasil" } ], "authenticated-orcid": false, "family": "Dusilek", "given": "Cesar", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0001-9708-0294", "affiliation": [ { "name": "Hospital do Rocio, Brasil" } ], "authenticated-orcid": false, "family": "Itinose", "given": "Kengi", "sequence": "additional" }, { "ORCID": "http://orcid.org/0009-0005-5583-6408", "affiliation": [ { "name": "Hospital do Rocio, Brasil" } ], "authenticated-orcid": false, "family": "Risson", "given": "Ricardo", "sequence": "additional" }, { "ORCID": "http://orcid.org/0009-0004-6049-7503", "affiliation": [ { "name": "Hospital do Rocio, Brasil" } ], "authenticated-orcid": false, "family": "Ferreira", "given": "Lucas Roberto Rivabem", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0003-2999-4961", "affiliation": [ { "name": "Brazilian Clinical Research Institute, Brasil; Duke University Medical Center, USA" } ], "authenticated-orcid": false, "family": "Lopes", "given": "Renato Delascio", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0003-2026-6925", "affiliation": [ { "name": "Universidade de São Paulo, Brasil" } ], "authenticated-orcid": false, "family": "Kallas", "given": "Esper Georges", "sequence": "additional" }, { "ORCID": "http://orcid.org/0000-0002-3736-7127", "affiliation": [ { "name": "Universidade de São Paulo, Brasil" } ], "authenticated-orcid": false, "family": "Bellissimo-Rodrigues", "given": "Fernando", "sequence": "additional" } ], "container-title": "Revista da Sociedade Brasileira de Medicina Tropical", "container-title-short": "Rev. 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Late treatment
is less effective
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