Pimenta Bonifácio: 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, 30 patient colchicine late treatment RCT: 85% better improvement [p=0.23] https://c19p.org/pimentabonifacio

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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)

Pimenta Bonifácio et al., SSRN Electronic Journal, doi:10.2139/ssrn.4095747, NCT04724629 (history)

28 Apr 2022 Source PDF Share Tweet

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).

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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, 20 authors, trial NCT04724629 (history).

Contact: fbellissimo@usp.br, livia_pb@usp.br.

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Late treatment
is less effective

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