Tocilizumab has been reported to attenuate the "
cytokine storm" in
COVID-19 patients. We attempted to verify the effectiveness and safety of
tocilizumab therapy in
COVID-19 and identify patients most likely to benefit from this treatment. We conducted a randomized, controlled, open-label multicenter trial among
COVID-19 patients. The patients were randomly assigned in a 1:1 ratio to receive either
tocilizumab in addition to standard care or standard care alone. The cure rate, changes of oxygen saturation and interference, and
inflammation biomarkers were observed. Thirty-three patients were randomized to the
tocilizumab group, and 32 patients to the control group. The cure rate in the
tocilizumab group was higher than that in the control group, but the difference was not statistically significant (94.12% vs. 87.10%, rate difference 95% CI-7.19%-21.23%, P = 0.4133). The improvement in
hypoxia for the
tocilizumab group was higher from day 4 onward and statistically significant from day 12 (P = 0.0359). In moderate disease patients with bilateral pulmonary lesions, the
hypoxia ameliorated earlier after
tocilizumab treatment, and less patients (1/12, 8.33%) needed an increase of inhaled
oxygen concentration compared with the controls (4/6, 66.67%; rate difference 95% CI-99.17% to-17.50%, P = 0.0217). No severe adverse events occurred. More mild temporary adverse events were recorded in
tocilizumab recipients (20/34, 58.82%) than the controls (4/31, 12.90%).
Tocilizumab can improve
hypoxia without unacceptable side effect profile and significant influences on the time virus load becomes negative. For patients with bilateral pulmonary lesions and elevated
IL-6 levels,
tocilizumab could be recommended to improve outcome.