NCT05113784

the Safety and Efficacy of Meplazumab in Patients With COVID-19

A Multicenter, Double-blind, Randomized Controlled, add-on Phase 2/3 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, randomized, placebo-controlled phase 2/3 clinical study. Based on the results of the Phase I clinical study, one repeat dose group and one placebo group are used for the standard treatment of the Novel Coronavirus Pneumonia Protocol (Trial 8) The treatment regimen is a one-time intravenous infusion of either mprozumab or placebo on day 1 (D1) and day 8 (D8) of the treatment period at a dose of 0.2 mg/kg based on body weight. An estimated 150 subjects will be randomly assigned to either Meplazumab or placebo in a 2:1 ratio A short-term efficacy evaluation was performed to determine the efficacy and safety of Meplazumab in each subject within 14 days of initial administration and a long-term follow-up evaluation was performed 28 days after initial administration to determine the safety of Meplazumab.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Meplazumab for Injection	humanized antibody target CD147
DRUG	Sterile normal saline (0.9%)	Sterile normal saline (0.9%)

Timeline

• Start date: 2022-01-21
• Primary completion: 2022-09-20
• Completion: 2022-10-08
• First posted: 2021-11-09
• Last updated: 2023-09-15

Locations

2 sites across 1 country: China