Meplazumab, a CD147 antibody, for severe COVID-19: a double-blind, randomized, placebo-controlled, phase 3 clinical trial

Meplazumab, a humanized CD147 antibody, showed favorable safety and clinical benefits in phase 1 and phase 2/3 seamless clinical studies. Further evaluation of its therapeutic efficacy in patients with severe COVID-19 is needed. In this phase 3 add-on study, we randomized patients with severe COVID-19 in a 1:1 ratio to receive 0.2 mg/kg meplazumab or placebo via intravenous injection, and evaluated efficacy and safety within 56 days. Between February 2023 and November 2023, 108 patients with severe COVID-19 were randomized to two groups, with their baseline characteristics generally balanced. The primary endpoint, 28-day all-cause mortality was 1.96% in the meplazumab group vs 7.69% in the placebo group (P = 0.1703). Supplementary analysis using composite strategy indicated a significant reduction of 28-day all-cause mortality in meplazumab compared to placebo (3.92% vs 15.38%, P = 0.044). Meplazumab also significantly reduced the mortality in smoking subjects on day 28 (P = 0.047) compared to placebo in supplementary analysis. The secondary endpoint, 56-day all-cause mortality, was 1.96% in the meplazumab group and 11.54% in the placebo group (P = 0.048), which was 3.92% and 15.38%, respectively (P = 0.044) by supplementary analysis. Additional secondary endpoints showed potential benefits, including increased hospital discharge rates, improved clinical outcomes, and improved viral nucleotide conversion rate. Meplazumab demonstrated good safety and tolerability, with no grade ≥ 3 TEAEs observed. These promising results indicate that meplazumab reduces mortality and enhances clinical benefits in severe COVID-19 patients with a good safety profile, providing effective and specific therapeutics for severe COVID-19 (the trial was registered at ClinicalTrials.gov (NCT05679479)).

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Publication Details

Journal
Signal Transduction and Targeted Therapy
Published
2025-04-13
DOI
https://doi.org/10.1038/s41392-025-02208-9
Citations
3
Primary Topic
Signaling Pathways in Disease
Type
article
Field-Weighted Citation Impact
2.42

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article

Meplazumab, a CD147 antibody, for severe COVID-19: a double-blind, randomized, placebo-controlled, phase 3 clinical trial

Ping Zhu, Aidong Wen, Zhaohui Zheng, Chen Liang et al.
3 citations
Signal Transduction and Targeted Therapy
Signaling Pathways in Disease
2.42
article

Meplazumab, a CD147 antibody, for severe COVID-19: a double-blind, randomized, placebo-controlled, phase 3 clinical trial

Ping Zhu, Aidong Wen, Zhaohui Zheng, Chen Liang, Huijie Bian, Zhi‐Nan Chen, Yingxia Liu, Xiang-Min Yang, Qingfeng Zeng, Jian-Li Jiang, Xijing Zhang, Jianqi Lian, Bin Wang, Lei Pan, Xing Gu, Tianyi Yang, Liuqing Yang, Liqiang Song, Yuanlong Lin, Junna Hou, Yu Liu, Yang Zhang, Xiaoxia Wang, Wenjie Li, Ling Li, Zheng Zhang, Jingwen Wang, Xiaochun Chen, Ruixuan Wang, Wei Ding, Xing Luo, Yang Xu, Qiuyue Tan, Hui Zhao, Mengying Yao, Ying Shi, Shuangshuang Liu, Xiaoxia Chen, Hongwei Shi, Lei Zhang, Junfeng Jia, Kui Zhang, Hao Tang, Honglin Dong, Xianghui Fu, Xiuxuan Sun, Xie Rong-hua, Yanyan Jia, Yong Yang, Jiao Wu, Qingyi Wang, Hai Feng Zhang
article en
3 citations

Abstract

Meplazumab, a humanized CD147 antibody, showed favorable safety and clinical benefits in phase 1 and phase 2/3 seamless clinical studies. Further evaluation of its therapeutic efficacy in patients with severe COVID-19 is needed. In this phase 3 add-on study, we randomized patients with severe COVID-19 in a 1:1 ratio to receive 0.2 mg/kg meplazumab or placebo via intravenous injection, and evaluated efficacy and safety within 56 days. Between February 2023 and November 2023, 108 patients with severe COVID-19 were randomized to two groups, with their baseline characteristics generally balanced. The primary endpoint, 28-day all-cause mortality was 1.96% in the meplazumab group vs 7.69% in the placebo group (P = 0.1703). Supplementary analysis using composite strategy indicated a significant reduction of 28-day all-cause mortality in meplazumab compared to placebo (3.92% vs 15.38%, P = 0.044). Meplazumab also significantly reduced the mortality in smoking subjects on day 28 (P = 0.047) compared to placebo in supplementary analysis. The secondary endpoint, 56-day all-cause mortality, was 1.96% in the meplazumab group and 11.54% in the placebo group (P = 0.048), which was 3.92% and 15.38%, respectively (P = 0.044) by supplementary analysis. Additional secondary endpoints showed potential benefits, including increased hospital discharge rates, improved clinical outcomes, and improved viral nucleotide conversion rate. Meplazumab demonstrated good safety and tolerability, with no grade ≥ 3 TEAEs observed. These promising results indicate that meplazumab reduces mortality and enhances clinical benefits in severe COVID-19 patients with a good safety profile, providing effective and specific therapeutics for severe COVID-19 (the trial was registered at ClinicalTrials.gov (NCT05679479)).

Signal Transduction and Targeted TherapyVol. 10(1)
Shanghai University (CN), Shanxi Medical University (CN), National Medical Products Administration (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), Second Hospital of Shanxi Medical University (CN), Tang Du Hospital (CN), First Affiliated Hospital of Zhengzhou University (CN), Xijing Hospital (CN), Xi'an Chest Hospital (CN), Shenzhen Third People’s Hospital (CN), Air Force Medical University (CN)
National Natural Science Foundation of China
Good health and well-being
Openalex Percentile: Top 12%
Signaling Pathways in Disease
2.42
DOIOpen Access PDFOpenAlex
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