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. 2021 Dec 22;22(1):317.
doi: 10.1186/s12931-021-01914-6.

Tocilizumab improves 28-day survival in hospitalized patients with severe COVID-19: an open label, prospective study

Theodoros Karampitsakos #  1 , Elli Malakounidou #  1 , Ourania Papaioannou  1 , Vasilina Dimakopoulou  2 , Eirini Zarkadi  1 , Matthaios Katsaras  1 , Panagiota Tsiri  1 , Georgios Tsirikos  1 , Vasiliki Georgiopoulou  1 , Ioanna Oikonomou  2 , Christos Davoulos  2 , Dimitrios Velissaris  2 , Fotios Sampsonas  1 , Markos Marangos #  2 , Karolina Akinosoglou #  2 , Argyris Tzouvelekis #  3
Affiliations

Tocilizumab improves 28-day survival in hospitalized patients with severe COVID-19: an open label, prospective study

Theodoros Karampitsakos et al. Respir Res. .

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 PaO2/FiO2 < 200 receiving tocilizumab plus usual care versus usual care alone. Tocilizumab was administered at the time point that PaO2/FiO2 < 200 was observed. The primary outcome was 28-day mortality. Secondary outcomes included time to discharge, change in PaO2/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]. ΔPaO2/FiO2 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 PaO2/FiO2 < 200 was observed, improved survival and other clinical outcomes in hospitalized patients with severe COVID-19 irrespective of systemic inflammatory markers levels.

Keywords: COVID-19; Mortality; Outcomes; PaO2/FiO2; Tocilizumab.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Schematic representation of the study design
Fig. 2
Fig. 2
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)], (A). 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: 9.0–16.0) vs 14.0 days (95% CI: 10.0–24.0), HR: 1.32 (95% CI: 0.84–2.08), p = 0.21], (B)
Fig. 3
Fig. 3
Forest plot of the primary endpoint (mortality) in prespecified subgroups. Estimates are based on a Cox proportional-hazards model
See this image and copyright information in PMC

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