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

NCT05113784 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-09-15

No results posted yet for this study

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

DRUG

Meplazumab for Injection

humanized antibody target CD147

DRUG

Sterile normal saline (0.9%)

Sterile normal saline (0.9%)

Sponsors & Collaborators

  • Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

    lead INDUSTRY

Principal Investigators

  • Hongzhou Lu · Shenzhen Third People's Hospital

  • Yinzhong Shen · Shanghai Public Health Clinical Center

  • Yingxia Liu · Shenzhen Third People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2022-09-20
Completion
2022-10-08

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05113784 on ClinicalTrials.gov