Volume 8 Issue 2, Feb 2023

ISSN: 2095-9907 

EISSN: 2059-23635 

2023 impact factor 40.8 

 (Clarivate Analytics, 2024)
Volume 8 Issue 2, Feb 2023:
Article
Meplazumab in hospitalized adults with severe COVID-19 (DEFLECT): a multicenter, seamless phase 2/3, randomized, third-party double-blind clinical trial
Huijie Bian  ORCID: orcid.org/0000-0003-4690-4622,Liang Chen,Zhao-Hui Zheng,Xiu-Xuan Sun,Jie-Jie Geng,Ruo Chen,Ke Wang  ORCID: orcid.org/0000-0001-8913-7115,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  ORCID: orcid.org/0000-0003-1610-8748,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 José Concilio Fucci,Jesus Abraham Simon-Campos,Ling Wang,Lin-Na Liu,Qing-Yi Wang,Ding Wei,Zheng Zhang,Zhi-Nan Chen &…Ping Zhu 
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.