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All Studies   Meta Analysis    Recent:   

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 (date from preprint), STRUCK, NCT04724629
Apr 2022  
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0 0.5 1 1.5 2+ Mortality 79% Improvement Relative Risk Improvement 85% Colchicine  STRUCK  LATE TREATMENT  RCT Is late treatment with colchicine beneficial for COVID-19? RCT 30 patients in Brazil (January - July 2021) Lower mortality (p=0.49) and greater improvement (p=0.23), not sig. c19early.org Pimenta Bonifácio et al., Revista da S.., Apr 2022 Favors colchicine Favors control
Colchicine for COVID-19
5th treatment shown to reduce risk in September 2020
 
*, now known with p = 0.00000031 from 56 studies.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
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).
The journal version of this paper falsely states: "Ixekizumab, colchicine, and IL-2 were demonstrated to be safe but ineffective".
The pre-print more accurately represents the improved but not statistically significant results:
"The colchicine arm presented the lowest mortality rate (0%), while the low dose IL-2 had the highest (21.4%) by day 28 post-enrollment. The frequency of adverse events was lowest in the colchicine group (7.3%). None of the differences observed was statistically significant. Interpretation: Colchicine added to SOC performed better than Ixekizumab, low-dose IL-2, or SOC alone for hospitalized patients with moderate to critical Covid-19 in this exploratory study. Larger studies are needed to confirm these findings."
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).
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).
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 5 January, 2021 - 30 July, 2021, dosage 1.5mg days 1-3, 1mg days 4-28, trial NCT04724629 (history) (STRUCK). Contact: fbellissimo@usp.br, livia_pb@usp.br.
This PaperColchicineAll
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)
Lívia Pimenta Bonifácio, Eduardo Ramacciotti, Leandro Barile Agati, Fernando Crivelenti Vilar, Anna Christina Tojal Da Silva, Paulo Louzada Júnior, Benedito Antônio Lopes Da Fonseca, Hayala Cristina Cavenague De Souza, Caroline Candida Carvalho De Oliveira, Valéria Cristina Resende Aguiar, Carlos Augusto De Aguiar Quadros, Cesar Dusilek, Kengi Itinose, Ricardo Risson, Lucas Roberto Rivabem Ferreira, Renato Delascio Lopes, Esper Georges Kallas, Dr Fernando Bellissimo-Rodrigues
Revista da Sociedade Brasileira de Medicina Tropical, doi:10.1590/0037-8682-0565-2022
data analysis; interpretation of results; critical revision of the final version for publication. FB-R -Study conception and design; study execution planning; supervision of the whole study team; interpretation of results; rewriting of the manuscript; critical analysis of the final version for publication. All authors reviewed the study, and approved the final version for publication. Authors hold themselves responsible for all aspects of the study, to ensure that all questions referring to accuracy and integrity are investigated and solved appropriately.
SUPPLEMENTARY TABLE 2: Plasma cytokine profiles (pg/mL) in COVID-19 patients at baseline (D 1) versus day 28 (D 28). SUPPLEMENTARY MATERIAL Groups
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{ 'issue': '12', 'key': 'ref25', 'doi-asserted-by': 'crossref', 'DOI': '10.1371/journal.pone.0242318', 'article-title': 'Colchicine reduces lung injury in experimental acute respiratory ' 'distress syndrome', 'volume': '15', 'author': 'Dupuis J', 'year': '2020', 'journal-title': 'PloS One'}, { 'issue': '1', 'key': 'ref26', 'doi-asserted-by': 'crossref', 'DOI': '10.1136/rmdopen-2020-001455', 'article-title': 'Beneficial effects of colchicine for moderate to severe COVID-19: a ' 'randomised, double-blinded, placebo-controlled clinical trial', 'volume': '7', 'author': 'Lopes MI', 'year': '2021', 'journal-title': 'RMD Open'}, { 'issue': '6979', 'key': 'ref27', 'doi-asserted-by': 'crossref', 'first-page': '198', 'DOI': '10.1038/nature02393', 'article-title': 'Insight into tubulin regulation from a complex with colchicine and a ' 'stathmin-like domain', 'volume': '428', 'author': 'Ravelli RB', 'year': '2004', 'journal-title': 'Nature'}, { 'issue': '8', 'key': 'ref28', 'doi-asserted-by': 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Soc. Bras. Med. Trop.', 'published': {'date-parts': [[2023]]}}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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