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Meplazumab in hospitalized adults with severe COVID-19(DEFLECT):a multicenter,seamless phase 2/3,randomized,third-party double-blind clinical trial

查看全文 作　　者：Huijie [1]Bian;Liang [2]Chen;Zhao-Hui [1]Zheng;Xiu-Xuan [1]Sun;Jie-Jie [1]Geng;Ruo [1]Chen;Ke [1]Wang;Xu [1]Yang;Shi-Rui [1]Chen;Si-Yu [1]Chen;Rong-Hua [1]Xie;Kui [1]Zhang;Jin-Lin [1]Miao;Jun-Feng [1]Jia;Hao [3]Tang;Shuang-Shuang [3]Liu;Hong-Wei [3]Shi;Yong [3]Yang;Xiao-Chun [3]Chen;Vinay [4]Malhotra;Nosheen [5]Nasir;Iffat [5]Khanum;Faisal [5]Mahmood;Saeed [5]Hamid;Claudio Marcel Berdun [6]Stadnik;Kengi [7]Itinose;Caroline Cândida Carvalho de [7]Oliveira;Cesar [7]Dusilek;Lucas [7]Rivabem;Adilson Joaquim Westheimer [8]Cavalcante;Suzara Souto [9]Lopes;Wladmir Faustino [10]Saporito;Fábio JoséConcilio [11]Fucci;Jesus Abraham Simon-[12]Campos;Ling [13]Wang;Lin-Na [14]Liu;Qing-Yi [15]Wang;Ding [1]Wei;Zheng [1]Zhang;Zhi-Nan [1]Chen;Ping [1]Zhu 高影响力作者 机构地区：[1]Department of Cell Biology of National Translational Science Center for Molecular Medicine and Department of Clinical Immunology of Xijing Hospital,Fourth Military Medical University,Xi’an,China;[2]Shanghai Engineering Research Center of Organ Repair,School of Medicine,Shanghai University,Shanghai,China;[3]Jiangsu Pacific Meinuoke Biopharmaceutical Co.Ltd,Changzhou,China;[4]Pulse Heart Institute Cardiology Services,MultiCare Institute for Research&Innovation,Tacoma,WA,USA;[5]Department of Medicine,The Aga Khan University,Karachi,Pakistan;[6]Infection Control Service,Irmandade Santa Casa de Misericord de Porto Alegre,Porto Alegre,Brazil;[7]Clinical Research Department,Hospital do Rocio,Campo Largo,Brazil;[8]CEMEC-Centro Multidisciplinar de Estudos Clínicos,São Bernardo do Campo,Brazil;[9]Chronos Pesquisa Clinica,Brasília,Brazil;[10]Pesquisare Saúde,Santo André,Brazil;[11]Instituto de Moléstias Cardiovasculares Tatuí,Tatuí,Brazil;[12]Kohler&Milstein Research/Hospital Agustín O’Horán,Mérida,Mexico;[13]College of Military Preventive Medicine,Fourth Military Medical University,Xi’an,China;[14]Department of Pharmaceutics,Tangdu Hospital,Fourth Military Medical University,Xi’an,China;[15]Department of Foreign Languages,Fourth Military Medical University,Xi’an,China高影响力机构 出　　处：《Signal Transduction and Targeted Therapy》索引2023年第8卷第2期,共9页高影响力期刊 基　　金：The DEFLECT is supported by grants from National Natural Science Foundation of China(No.92169211).Jiangsu Pacific Meinuoke Biopharmaceuticals provided meplazumab.The views expressed in this article is the authors’opinion,not the opinion or policy of funder. 摘　　要：Meplazumab,a humanized CD147 antibody,has shown favourable safety and efficacy in our previous clinical studies.In DEFLECT(NCT04586153),167 patients with severe COVID-19 were enroled and randomized to receive three dosages of meplazumab and a placebo.Meplazumab at 0.12 mg/kg,compared to the placebo group,showed clinical benefits in significantly reducing mortality by 83.6%(2.4%vs.14.6%,p=0.0150),increasing the proportion of patients alive and discharged without supplemental oxygen(82.9%vs.70.7%,p=0.0337)and increasing the proportion of patients who achieved sustained clinical improvement(41.5%vs.31.7%).The response rate in the 0.2 mg/kg group was relatively increased by 16.0%compared with the placebo group(53.7%vs.46.3%).Meplazumab also reduced the viral loads and multiple cytokine levels.Compare with the placebo group,the 0.3 mg/kg significantly increased the virus negative rate by 40.6%(p=0.0363)and reduced IL-8 level(p=0.0460);the 0.2 mg/kg increased the negative conversion rate by 36.9%,and reduced IL-4(p=0.0365)and IL-8 levels(p=0.0484).In this study,the adverse events occurred at a comparable rate across the four groups,with no unexpected safety findings observed.In conclusion,meplazumab promoted COVID-19 convalescence and reduced mortality,viral load,and cytokine levels in severe COVID-19 population with good safety profile. 关 键 词：clinical mortality DOSAGE
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