Back to resultsthe Safety and Efficacy of Meplazumab in Patients With COVID-19
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Meplazumab for Injection
Sterile normal saline (0.9%)
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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.
Sites / Locations
- Shanghai Public Health Clinical Center
- The Third People's Hospital Of Shenzhen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Meplazumab for Injection
Placebo
Arm Description
First dose: 0.2 mg/kg - Day 1; Second dose: 0.2 mg/kg - Day 8
First dose: control - Day 1; Second dose: control -Day 8
Outcomes
Primary Outcome Measures
Time of virus nucleic acid test turning negative
Time of virus nucleic acid test turning negative
Secondary Outcome Measures
Treatment to discharge time
Treatment to discharge time
Evolution of the imaging parameters
Changes from pre-dose baseline in CT
Assessment of the immune response profile
Immune response profile characterized according immune cells and subsets and CRP.
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
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
Full Information
NCT ID
NCT05113784
First Posted
September 17, 2021
Last Updated
September 14, 2023
Sponsor
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05113784
Brief Title
the Safety and Efficacy of Meplazumab in Patients With COVID-19
Official Title
A Multicenter, Double-blind, Randomized Controlled, add-on Phase 2/3 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2022 (Actual)
Primary Completion Date
September 20, 2022 (Actual)
Study Completion Date
October 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meplazumab for Injection
Arm Type
Experimental
Arm Description
First dose: 0.2 mg/kg - Day 1; Second dose: 0.2 mg/kg - Day 8
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
First dose: control - Day 1; Second dose: control -Day 8
Intervention Type
Drug
Intervention Name(s)
Meplazumab for Injection
Intervention Description
humanized antibody target CD147
Intervention Type
Drug
Intervention Name(s)
Sterile normal saline (0.9%)
Intervention Description
Sterile normal saline (0.9%)
Primary Outcome Measure Information:
Title
Time of virus nucleic acid test turning negative
Description
Time of virus nucleic acid test turning negative
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
Treatment to discharge time
Description
Treatment to discharge time
Time Frame
up to 28 days
Title
Evolution of the imaging parameters
Description
Changes from pre-dose baseline in CT
Time Frame
up to day28
Title
Assessment of the immune response profile
Description
Immune response profile characterized according immune cells and subsets and CRP.
Time Frame
up to day28
Title
Assessment of the biochemistry profile
Description
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
Title
Assessment of the cytokines profile
Description
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
Time Frame
up to day28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongzhou Lu
Organizational Affiliation
Shenzhen Third People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yinzhong Shen
Organizational Affiliation
Shanghai Public Health Clinical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yingxia Liu
Organizational Affiliation
Shenzhen Third People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The Third People's Hospital Of Shenzhen
City
Shenzhen
Country
China
12. IPD Sharing Statement
Learn more about this trial
the Safety and Efficacy of Meplazumab in Patients With COVID-19
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