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

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...

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Autores principales: Wang, Dongsheng, Fu, Binqing, Peng, Zhen, Yang, Dongliang, Han, Mingfeng, Li, Min, Yang, Yun, Yang, Tianjun, Sun, Liangye, Li, Wei, Shi, Wei, Yao, Xin, Ma, Yan, Xu, Fei, Wang, Xiaojing, Chen, Jun, Xia, Daqing, Sun, Yubei, Dong, Lin, Wang, Jumei, Zhu, Xiaoyu, Zhang, Min, Zhou, Yonggang, Pan, Aijun, Hu, Xiaowen, Mei, Xiaodong, Wei, Haiming, Xu, Xiaoling
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Higher Education Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7940448/
https://www.ncbi.nlm.nih.gov/pubmed/33687643
http://dx.doi.org/10.1007/s11684-020-0824-3
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author Wang, Dongsheng
Fu, Binqing
Peng, Zhen
Yang, Dongliang
Han, Mingfeng
Li, Min
Yang, Yun
Yang, Tianjun
Sun, Liangye
Li, Wei
Shi, Wei
Yao, Xin
Ma, Yan
Xu, Fei
Wang, Xiaojing
Chen, Jun
Xia, Daqing
Sun, Yubei
Dong, Lin
Wang, Jumei
Zhu, Xiaoyu
Zhang, Min
Zhou, Yonggang
Pan, Aijun
Hu, Xiaowen
Mei, Xiaodong
Wei, Haiming
Xu, Xiaoling
author_facet Wang, Dongsheng
Fu, Binqing
Peng, Zhen
Yang, Dongliang
Han, Mingfeng
Li, Min
Yang, Yun
Yang, Tianjun
Sun, Liangye
Li, Wei
Shi, Wei
Yao, Xin
Ma, Yan
Xu, Fei
Wang, Xiaojing
Chen, Jun
Xia, Daqing
Sun, Yubei
Dong, Lin
Wang, Jumei
Zhu, Xiaoyu
Zhang, Min
Zhou, Yonggang
Pan, Aijun
Hu, Xiaowen
Mei, Xiaodong
Wei, Haiming
Xu, Xiaoling
author_sort Wang, Dongsheng
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: Supplementary material is available in the online version of this article at 10.1007/s11684-020-0824-3 and is accessible for authorized users.
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spelling pubmed-79404482021-03-09 Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial Wang, Dongsheng Fu, Binqing Peng, Zhen Yang, Dongliang Han, Mingfeng Li, Min Yang, Yun Yang, Tianjun Sun, Liangye Li, Wei Shi, Wei Yao, Xin Ma, Yan Xu, Fei Wang, Xiaojing Chen, Jun Xia, Daqing Sun, Yubei Dong, Lin Wang, Jumei Zhu, Xiaoyu Zhang, Min Zhou, Yonggang Pan, Aijun Hu, Xiaowen Mei, Xiaodong Wei, Haiming Xu, Xiaoling Front Med Research Article 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. ELECTRONIC SUPPLEMENTARY MATERIAL: Supplementary material is available in the online version of this article at 10.1007/s11684-020-0824-3 and is accessible for authorized users. Higher Education Press 2021-03-09 2021 /pmc/articles/PMC7940448/ /pubmed/33687643 http://dx.doi.org/10.1007/s11684-020-0824-3 Text en © Higher Education Press 2021 This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Research Article
Wang, Dongsheng
Fu, Binqing
Peng, Zhen
Yang, Dongliang
Han, Mingfeng
Li, Min
Yang, Yun
Yang, Tianjun
Sun, Liangye
Li, Wei
Shi, Wei
Yao, Xin
Ma, Yan
Xu, Fei
Wang, Xiaojing
Chen, Jun
Xia, Daqing
Sun, Yubei
Dong, Lin
Wang, Jumei
Zhu, Xiaoyu
Zhang, Min
Zhou, Yonggang
Pan, Aijun
Hu, Xiaowen
Mei, Xiaodong
Wei, Haiming
Xu, Xiaoling
Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial
title Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial
title_full Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial
title_fullStr Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial
title_full_unstemmed Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial
title_short Tocilizumab in patients with moderate or severe COVID-19: a randomized, controlled, open-label, multicenter trial
title_sort tocilizumab in patients with moderate or severe covid-19: a randomized, controlled, open-label, multicenter trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7940448/
https://www.ncbi.nlm.nih.gov/pubmed/33687643
http://dx.doi.org/10.1007/s11684-020-0824-3
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