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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

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Signal Transduction and Targeted Therapy 2023年第2期8卷 842-850页

作者： Huijie Bian Liang Chen Zhao-Hui Zheng Xiu-Xuan Sun Jie-Jie Geng Ruo Chen Ke Wang Xu Yang Shi-Rui Chen Si-Yu Chen Rong-Hua Xie Kui Zhang Jin-Lin Miao Jun-Feng Jia Hao Tang Shuang-Shuang Liu Hong-Wei Shi Yong Yang Xiao-Chun Chen Vinay Malhotra Nosheen Nasir Iffat Khanum Faisal Mahmood saeed Hamid Claudio Marcel Berdun Stadnik Kengi Itinose Caroline Cândida Carvalho de Oliveira Cesar Dusilek Lucas Rivabem Adilson Joaquim Westheimer Cavalcante Suzara Souto Lopes Wladmir Faustino saporito Fábio JoséConcilio Fucci Jesus Abraham Simon-Campos Ling Wang Lin-Na Liu Qing-Yi Wang Ding Wei Zheng Zhang Zhi-Nan Chen Ping Zhu department of Cell Biology of National Translational Science Center for Molecular Medicine and department of Clinical Immunology of Xijing Hospital Fourth Military Medical UniversityXi’anChina Shanghai Engineering Research Center of Organ Repair School of MedicineShanghai UniversityShanghaiChina Jiangsu Pacific Meinuoke Biopharmaceutical Co.Ltd ChangzhouChina Pulse Heart Institute Cardiology Services MultiCare Institute for Research&InnovationTacomaWAUSA department of Medicine The Aga Khan UniversityKarachiPakistan Infection Control Service Irmandade Santa Casa de Misericord de Porto AlegrePorto AlegreBrazil Clinical Research department Hospital do RocioCampo LargoBrazil CEMEC-Centro Multidisciplinar de Estudos Clínicos São Bernardo do CampoBrazil Chronos Pesquisa Clinica BrasíliaBrazil pesquisare saúde Santo AndréBrazil Instituto de Moléstias Cardiovasculares Tatuí TatuíBrazil Kohler&Milstein Research/Hospital Agustín O’Horán MéridaMexico College of Military Preventive Medicine Fourth Military Medical UniversityXi’anChina department of Pharmaceutics Tangdu HospitalFourth Military Medical UniversityXi’anChina department of Foreign Languages Fourth Military Medical UniversityXi’anChina

Meplazumab,a humanized CD147 antibody,has shown favourable safety and efficacy in our previous clinical *** deFLECT(NCT04586153),167 patients with severe COVID-19 were enroled and randomized to receive three dosages of meplazumab and a *** 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 *** 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 *** 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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