A multicenter, double-blind, randomized placebo-controlled phase Ⅱ / Ⅲ clinical trial of meplazumab in the treatment of COVID-19
Journal Title: Journal of Air Force Medical University - Year 2023, Vol 44, Issue 7
Abstract
Objective Meplazumab is a humanized anti-CD147 IgG2 monoclonal antibody, which can inhibit the virus from invading human host cells by blocking the interaction between CD147 and the spike protein of severe acute respiratory syndrome coronavirus 2. To evaluate the safety and efficacy of meplazumab in patients with coronavirus disease 2019 ( COVID-19), we designed and conducted this clinical study. Methods This clinical study was a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ / Ⅲ clinical trial. Enrolled hospitalized patients were randomly allocated into meplazumab group or placebo control group according to the ratio of 2 ∶ 1. The meplazumab group received an intravenous infusion of 0. 2 mg/ kg meplazumab on day 1 and day 8. Within 14 d of the first administration, a short-term follow-up was performed to determine the therapeutic efficacy and safety of meplazumab. Results A total of 150 subjects were enrolled, including 100 subjects in the meplazumab group and 50 subjects in the placebo control group, and the demographic characteristics of the two groups were evenly distributed. There were no significant differences in the incidence and severity of adverse events between the two groups during the clinical study. On day 3 to day 5 after administration, the negative conversion rate of the meplazumab group increased by 22. 5% - 96. 1% compared with the placebo control group. On day 4 to day 8 after administration, the discharge rate of the meplazumab group increased by 34. 8% -145. 1% compared with the placebo control group. Conclusion Meplazumab is safe and well tolerated in patients with COVID-19, and repeated intravenous infusion of 0. 2 mg/ kg meplazumab can improve the viral negative conversion rate and discharge rate in the early stage after treatment.
Authors and Affiliations
WEI Ding, ZHANG Zheng, ZHENG Zhaohui, ZHANG Kui, LU Hongzhou, LIU Yingxia, SHEN Yinzhong, WANG Li,ZHANG Shuai, YANG Xiangmin, SHI Hongwei, LIU Shuangshuang, TANG Hao, CHEN Xiaochun, ZHU Ping,BIAN Huijie, CHEN Zhinan
Keywords
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