Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial.

Dongsheng Wang; Binqing FU; Zhen Peng; Dongliang Yang; Mingfeng Han; Min LI; Yun Yang; Tianjun Yang; Liangye Sun; Wei LI; Wei Shi; Xin Yao; Yan MA; Fei XU; Xiaojing Wang; Jun Chen; Daqing Xia; Yubei Sun; Lin Dong; Jumei Wang; Xiaoyu Zhu; Min Zhang; Yonggang Zhou; Aijun Pan; Xiaowen HU; Xiaodong Mei; Haiming Wei; Xiaoling XU

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Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial.

Author: Dongsheng WANG ¹ ; Binqing FU ² ; Zhen PENG ³ ; Dongliang YANG ⁴ ; Mingfeng HAN ⁵ ; Min LI ⁶ ; Yun YANG ⁷ ; Tianjun YANG ⁷ ; Liangye SUN ⁸ ; Wei LI ⁹ ; Wei SHI ¹⁰ ; Xin YAO ¹¹ ; Yan MA ¹² ; Fei XU ¹ ; Xiaojing WANG ¹ ; Jun CHEN ¹ ; Daqing XIA ¹ ; Yubei SUN ¹³ ; Lin DONG ¹⁴ ; Jumei WANG ¹⁴ ; Xiaoyu ZHU ¹⁵ ; Min ZHANG ¹² ; Yonggang ZHOU ² ; Aijun PAN ⁷ ; Xiaowen HU ¹ ; Xiaodong MEI ¹⁶ ; Haiming WEI ¹⁷ ; Xiaoling XU ¹⁸
Author Information

1. Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.
2. Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230027, China.
3. Drug Clinical Trail Institution, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230001, China.
4. Department of Infectious Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430000, China.
5. Department of Respiratory Medicine, the Second People's Hospital of Fuyang, Fuyang, 236000, China.
6. Department of Respiratory Medicine, National Key Clinical Specialty, Branch of National Clinical Research Center for Respiratory Disease, Xiangya Hospital, Central South University, Xiangya Lung Cancer Center, Xiangya Hospital, Central South University, Hunan Provincial Clinical Research Center for Respiratory Diseases, Changsha, 410000, China.
7. Intensive Care Unit, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.
8. Lu'an People's Hospital Affiliated to Anhui Medical University, Lu'an, 237005, China.
9. Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of Bengbu Medical College, Clinical Research Center for Respiratory Disease (tumor) in Anhui Province, Bengbu, 233004, China.
10. Department of Respiratory Medicine, Anqing Hospital Affiliated to Anhui Medical University, Anqing, 246000, China.
11. The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210000, China.
12. Department of Rheumatology and Immunology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.
13. Department of Oncology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.
14. Department of Endocrinology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.
15. Department of Hematology, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China.
16. Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China. hfmxd@sina.com.
17. Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, 230027, China. ustcwhm@ustc.edu.cn.
18. Department of Pulmonary and Critical Care Medicine, the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Hefei, 230001, China. xxlahh8@ustc.edu.cn.
Publication Type:Randomized Controlled Trial
Keywords: Coronavirus disease 2019 (COVID-19); cytokine storm; tocilizumab
MeSH: Antibodies, Monoclonal, Humanized; COVID-19/drug therapy*; Humans; SARS-CoV-2; Treatment Outcome
From: Frontiers of Medicine 2021;15(3):486-494
CountryChina
Language:English
Abstract: 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.