meplazumab for injection
Drughumanized antibody target CD147
NCT Number: NCT05113784
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 2 / Phase 3
Shanghai Public Health Clinical Center, Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
humanized antibody target CD147
Sterile normal saline (0.9%)
Time frame: up to 14 days
Time of virus nucleic acid test turning negative
Time frame: up to 28 days
Treatment to discharge time
Time frame: up to day28
Changes from pre-dose baseline in CT
Time frame: up to day28
Immune response profile characterized according immune cells and subsets and CRP.
Time frame: up to day28
Change from pre-dose baseline in blood biochemistry:Fbg,Cr,BUN,UA,AST,ALT,g-GT,TBIL,ALB,TP,NA,K,Ca,CL
Time frame: up to day28
Change from pre-dose baseline in cytokines:IL-1b、IL-6、IL-8、IL-10、IL-17、CCL2、CXCL-1、CXCL-2、IFN-γ、TNFα、CyPA
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Industry
A Multicenter, Double-blind, Randomized Controlled, add-on Phase 2/3 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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