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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Meplazumab for Injection; Drug: Sterile normal saline (0.9%)

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shenzhen, China
    • The Third People's Hospital of Shenzhen
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Public Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years ≤Subject ≤ 75 years, Male and/or female;
• Clinical confirmation of COVID-19 patients in accordance with novel Coronavirus Diagnosis and Treatment Protocol (Trial Version 8) of the NHC
• Participants must be able to understand and willing to participate in this research, this study and signed informed consent form (if incapacitated subjects, the researchers believe the subjects to the test in its own interests, should be signed by its legal guardian informed consent, or telephone inform consent (recording) and note it in the original medical records and other relevant documents)

Exclusion Criteria:

• Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent;
• SARS-CoV-2 infection by PCR ≥ 96h;
• Platelet (PLT) < 50×10^9/L, or hemoglobin (HGB) < 60g/L;
• Total bilirubin (TBIL) > 2×ULN (upper limit of normal value), or alanine transferase (ALT), aspartate transferase (AST), alkaline phosphatase (ALP) > 5×ULN;
• glomerular filtration rate (GFR) < 30mL/min·1.73m^2, or serum creatinine increased by 0.5mg/ dL within 7 days, or oliguria (<400mL/24hr), or anuria (<100mL/24hr);
• Pregnant or breast feeding;
• Persons who have family planning or do not agree to use effective non-drug contraceptive measures within 6 months after signing the ICF;
• Subjects participating in another clinical study. There will be a need for washout with 5 half lives depending on the study treatment or 30 days since any previous study, whichever is longer;
• he inestigators concluded that the patients had other reasons for not being eligible for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meplazumab for Injection; First dose: 0.2 mg/kg - Day 1; Second dose: 0.2 mg/kg - Day 8	Drug: Meplazumab for Injection; humanized antibody target CD147
Placebo Comparator: Placebo; First dose: control - Day 1; Second dose: control -Day 8	Drug: Sterile normal saline (0.9%); Sterile normal saline (0.9%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of virus nucleic acid test turning negative	Time of virus nucleic acid test turning negative	up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment to discharge time	Treatment to discharge time	up to 28 days
Evolution of the imaging parameters	Changes from pre-dose baseline in CT	up to day28
Assessment of the immune response profile	Immune response profile characterized according immune cells and subsets and CRP.	up to day28
Assessment of the biochemistry profile	Change from pre-dose baseline in blood biochemistry:Fbg,Cr,BUN,UA,AST,ALT,g-GT,TBIL,ALB,TP,NA,K,Ca,CL	up to day28
Assessment of the cytokines profile	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	up to day28

Collaborators and Investigators

• Sponsor: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
• Investigators: Principal Investigator: Hongzhou Lu, Shenzhen Third People's Hospital; Principal Investigator: Yinzhong Shen, Shanghai Public Health Clinical Center; Principal Investigator: Yingxia Liu, Shenzhen Third People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): September 20, 2022
• Study Completion (Actual): October 8, 2022

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiviral Agents; Meplazumab
• Other Study ID Numbers: MPZ-II-01-CN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No