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

NCT05113784 | Completed Phase 2

• 1 other identifier: MPZ-II-01-CN
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time of virus nucleic acid test turning negative

  Time of virus nucleic acid test turning negative

  up to 14 days

Secondary Outcomes (5)

• Treatment to discharge time

  up to 28 days

• Evolution of the imaging parameters

  up to day28

• Assessment of the immune response profile

  up to day28

• Assessment of the biochemistry profile

  up to day28

• Assessment of the cytokines profile

  up to day28

Study Arms (2)

Meplazumab for Injection

EXPERIMENTAL

First dose: 0.2 mg/kg - Day 1; Second dose: 0.2 mg/kg - Day 8

Drug: Meplazumab for Injection

Placebo

PLACEBO COMPARATOR

First dose: control - Day 1; Second dose: control -Day 8

Drug: Sterile normal saline (0.9%)

Interventions

Meplazumab for Injection DRUG

humanized antibody target CD147

Meplazumab for Injection

Sterile normal saline (0.9%) DRUG

Sterile normal saline (0.9%)

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd: lead

Study Sites (2)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Location

The Third People's Hospital Of Shenzhen

Shenzhen, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

meplazumab; Injections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: November 9, 2021
• Study Start: January 21, 2022
• Primary Completion: September 20, 2022
• Study Completion: October 8, 2022
• Last Updated: September 15, 2023

Record last verified: 2022-03

Locations

CN (2)