Background Data on the safety and efficacy profile of tocilizumab in patients with severe COVID-19 needs to be enriched. Methods In this open label, prospective study, we evaluated clinical outcomes in consecutive patients with COVID-19 and PaO 2 /FiO 2 < 200 receiving tocilizumab plus usual care versus usual care alone. Tocilizumab was administered at the time point that PaO 2 /FiO 2 < 200 was observed. The primary outcome was 28-day mortality. Secondary outcomes included time to discharge, change in PaO 2 /FiO2 at day 5 and change in WHO progression scale at day 10. Findings Overall, 114 patients were included in the analysis (tocilizumab plus usual care: 56, usual care: 58). Allocation to usual care was associated with significant increase in 28-day mortality compared to tocilizumab plus usual care [Cox proportional-hazards model: HR: 3.34, (95% CI: 1.21–9.30), (p = 0.02)]. There was not a statistically significant difference with regards to hospital discharge over the 28 day period for patients receiving tocilizumab compared to usual care [11.0 days (95% CI: 9.0 to 16.0) vs 14.0 days (95% CI: 10.0–24.0), HR: 1.32 (95% CI: 0.84–2.08), p = 0.21]. ΔPaO 2 /FiO 2 at day 5 was significantly higher in the tocilizumab group compared to the usual care group [42.0 (95% CI: 23.0–84.7) vs 15.8 (95% CI: − 19.4–50.3), p = 0.03]. ΔWHO scale at day 10 was significantly lower in the tocilizumab group compared to the usual care group (-0.5 ± 2.1 vs 0.6 ± 2.6, p = 0.005). Conclusion Administration of tocilizumab, at the time point that PaO 2 /FiO 2 < 200 was observed, improved survival and other clinical outcomes in hospitalized patients with severe COVID-19 irrespective of systemic inflammatory markers levels. Supplementary Information The online version contains supplementary material available at 10.1186/s12931-021-01914-6.
【저자키워드】 COVID-19, Mortality, Tocilizumab, outcomes, PaO2/FiO2, 【초록키워드】 Efficacy, severe COVID-19, Tocilizumab, Prospective Study, 28-day mortality, progression, outcome, hospitalized patients, discharge, clinical outcomes, Clinical outcome, survival, Patient, WHO, allocation, Analysis, open, Primary outcome, FiO2, supplementary material, 95% CI, consecutive patients, open label, Secondary outcomes, usual care, significant increase, hospital discharge, statistically significant difference, usual care group, finding, significantly lower, Administered, secondary, evaluated, receiving, hospitalized patient, significantly higher, consecutive patient, PaO, systemic inflammatory marker, usual care alone, with COVID-19, 【제목키워드】 Tocilizumab, survival, open label, IMPROVE, hospitalized patient,