Meplazumab in hospitalized adults with severe COVID-19 (DEFLECT): a multicenter, seamless phase 2/3, randomized, third-party double-blind clinical trial.
Рандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование II фазыКлиническое исследование III фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Bian Huijie, Chen Liang, Zheng Zhao-Hui, Sun Xiu-Xuan, Geng Jie-Jie, Chen Ruo, Wang Ke, Yang Xu, Chen Shi-Rui, Chen Si-Yu, Xie Rong-Hua, Zhang Kui, Miao Jin-Lin, Jia Jun-Feng, Tang Hao, Liu Shuang-Shuang, Shi Hong-Wei, Yang Yong, Chen Xiao-Chun, Malhotra Vinay, Nasir Nosheen, Khanum Iffat, Mahmood Faisal, Hamid Saeed, Stadnik Claudio Marcel Berdun, Itinose Kengi, de Oliveira Caroline Cândida Carvalho, Dusilek Cesar, Rivabem Lucas, Cavalcante Adilson Joaquim Westheimer, Lopes Suzara Souto, Saporito Wladmir Faustino, Fucci Fábio José Concilio, Simon-Campos Jesus Abraham, Wang Ling, Liu Lin-Na, Wang Qing-Yi, Wei Ding, Zhang Zheng, Chen Zhi-Nan, Zhu Ping
Аннотация
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.