Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19

Summary

This is a multicenter, double-blind, randomized, placebo-controlled, loaded Phase III clinical study. This test is in a new coronavirus infection pneumonia diagnosis and treatment plan of 9 (trial version) "(SoC), on the basis of the standard treatments according to the results of clinical studies have been obtained, using a dose of 0.2 mg/kg, and a placebo. The regimen consisted of a single intravenous infusion of Meplazumab or placebo on day 1 (d0) of the treatment period and d7 after initial administration at a dose of 0.2 mg/kg calculated according to body weight. It is expected that 350 subjects will be randomly assigned to Meplazumab or placebo in a 1:1 ratio. Short-term efficacy evaluation was performed for each subject within 28 days after initial administration to determine the therapeutic efficacy and safety of Meplazumab. Long-term follow-up evaluation was performed within 56 days of initial administration to determine the safety of Meplazumab in each subject.

Timeline

Start

2024-01-19

Primary completion

2024-01-30

Completion

2024-04-18

Outcome

Missed primary endpoint

paper The primary endpoint, 28-day all-cause mortality was 1.96% in the meplazumab group vs 7.69% in the placebo group (P = 0.1703). PMID 40222976 ↗

Publications

• Bian H, Chen L, Zhang Z, Wen AD, Zheng ZH, Song LQ, Yao MY, Liu YX, Zhang XJ, Dong HL, Lian JQ, Pan L, Liu Y, Gu X, Zhao H, Wang JW, Wang QY, Zhang K, Jia JF, Xie RH, Luo X, Fu XH, Jia YY, Hou JN, Tan QY, Chen XX, Yang LQ, Lin YL, Wang XX, Zhang L, Zeng QJ, Li WJ, Wang RX, Zhang Y, Sun XX, Wang B, Yang X, Jiang JL, Li L, Wu J, Yang XM, Zhang H, Shi Y, Chen XC, Tang H, Shi HW, Liu SS, Yang Y, Yang TY, Wei D, Chen ZN, Zhu P. Meplazumab, a CD147 antibody, for severe COVID-19: a double-blind, randomized, placebo-controlled, phase 3 clinical trial. Signal Transduct Target Ther. 2025 Apr 14;10(1):119. doi: 10.1038/s41392-025-02208-9.

Drugs

Indications