NCT05679479

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

A Multicenter, Double-blind, Randomized, Placebo-controlled, Loaded Phase III Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Meplazumab for injection	Meplazumab is a humanized anti-CD147 immunoglobulin 2 (IgG2) monoclonal antibody which is expected to block the binding of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein to the human host-cell-expressed CD147, thereby blocking entry of SARS-CoV-2 into human tissue. This expectation is based on in vitro functional studies using Vero E6 cells infected with SARS-CoV-2 that demonstrated effective meplazumab mediated virus gene copy number inhibition upwards of 90% as evaluated by quantitative polymerase chain reaction. Meplazumab may also inhibit COVID-19 associated cytokine storm syndrome based on inhibition of the pro inflammatory factor Cyclophilin A host-cell CD147 interaction.
OTHER	Normal saline	0.9% normal saline

Timeline

• Start date: 2024-01-19
• Primary completion: 2024-01-30
• Completion: 2024-04-18
• First posted: 2023-01-11
• Last updated: 2024-05-28

Locations

1 site across 1 country: China