Tocilizumab improves 28-day survival in hospitalized patients with severe COVID-19: an open label, prospective study
Τheodoros Karampitsakos, Elli Malakounidou, Ουρανία Παπαϊωάννου, Vasilina Dimakopoulou, Eirini Zarkadi, Matthaios Katsaras, Panagiota Tsiri, Georgios Tsirikos, Vasiliki V. Georgiopoulou, Ioanna Oikonomou, Christos Davoulos, Dimitrios Velissaris, Fotios Sampsonas, Markos Marangos, Karolina Akinosoglou, Αrgyris Τzouvelekis
Abstract
Abstract 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.