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Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study

Campochiaro et al., European Journal of Internal Medicine, doi:10.1016/j.ejim.2020.05.021, NCT04318366, Jun 2020
https://c19early.org/campochiaro.html
Mortality 53% Improvement Relative Risk Ventilation -106% Discharge 27% Improvement 21% Tocilizumab  Campochiaro et al.  LATE TREATMENT Is late treatment with tocilizumab beneficial for COVID-19? Retrospective 65 patients in Italy (March - March 2020) Lower mortality (p=0.15) and higher ventilation (p=0.43), not sig. c19early.org Campochiaro et al., European J. Intern.., Jun 2020 Favorstocilizumab Favorscontrol 0 0.5 1 1.5 2+
\Retrospective 65 severe COVID-19 patients showing no statistically significant differences with tocilizumab.
risk of death, 53.1% lower, RR 0.47, p = 0.15, treatment 5 of 32 (15.6%), control 11 of 33 (33.3%), NNT 5.6.
risk of mechanical ventilation, 106.2% higher, RR 2.06, p = 0.43, treatment 4 of 32 (12.5%), control 2 of 33 (6.1%).
risk of no hospital discharge, 27.2% lower, RR 0.73, p = 0.32, treatment 12 of 32 (37.5%), control 17 of 33 (51.5%), NNT 7.1.
risk of no improvement, 20.7% lower, RR 0.79, p = 0.61, treatment 10 of 32 (31.2%), control 13 of 33 (39.4%), NNT 12.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Campochiaro et al., 30 Jun 2020, retrospective, Italy, peer-reviewed, 16 authors, study period 13 March, 2020 - 19 March, 2020, trial NCT04318366 (history). Contact: campochiaro.corrado@hsr.it, lorenzo.dagna@unisr.it.
Efficacy and safety of tocilizumab in severe COVID-19 patients: a single-centre retrospective cohort study
Corrado Campochiaro, Emanuel Della-Torre, Giulio Cavalli, Giacomo De Luca, Marco Ripa, Nicola Boffini, Alessandro Tomelleri, Elena Baldissera, Patrizia Rovere-Querini, Annalisa Ruggeri, Giacomo Monti, Francesco De Cobelli, Alberto Zangrillo, Moreno Tresoldi, Antonella Castagna, Lorenzo Dagna
European Journal of Internal Medicine, doi:10.1016/j.ejim.2020.05.021
Background: Tocilizumab (TCZ), a humanized monoclonal antibody targeting the interleukin-6 (IL-6) receptor, has been proposed for the treatment of COVID-19 patients; however, limited data are available on the safety and efficacy. Methods: We performed a retrospective study on severe COVID-19 patients with hyper-inflammatory features admitted outside intensive care units (ICUs). Patients treated with intravenous TCZ in addition to standard of care were compared to patients treated with standard of care alone. Safety and efficacy were assessed over a 28day follow-up. Results: 65 patients were included. Among them, 32 were treated with TCZ. At baseline, all patients were on high-flow supplemental oxygen and most (78% of TCZ patients and 61% of standard treatment patients) were on non-invasive ventilation. During the 28-day follow-up, 69% of TCZ patients experienced a clinical improvement compared to 61% of standard treatment patients (p = 0.61). Mortality was 15% in the tocilizumab group and 33% in standard treatment group (p = 0.15). In TCZ group, at multivariate analysis, older age was a predictor of death, whereas higher baseline PaO2:FiO2 was a predictor of clinical improvement at day 28. The rate of infection and pulmonary thrombosis was similar between the two groups. Conclusions: At day 28, clinical improvement and mortality were not statistically different between tocilizumab and standard treatment patients in our cohort. Bacterial or fungal infections were recorded in 13% of tocilizumab patients and in 12% of standard treatment patients. Confirmation of efficacy and safety will require ongoing controlled trials.
Conclusions In our study, we did not observe clear improvements in patients receiving tocilizumab compared to standard management. Infectious adverse events require careful monitoring to evaluate long-term risks. The results of ongoing randomized placebo-controlled trials are eagerly awaited to establish the role of IL-6 blockade in severe COVID-19 patients, and whether tocilizumab therapy might be safely and effectively used for treating COVID-19. Declaration of competing interest The authors declare no conflict of interest.
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Zangrillo, Beretta, Silvani, Fast reshaping of intensive care unit facilities in a large metropolitan hospital in Milan, Italy: facing the COVID-19 pandemic emergency, Crit Care Resusc
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Late treatment
is less effective
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