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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Meplazumab for injection
Normal saline
Sponsored by
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18 to 80 (including 18 and 80 years old), male and female, By PCR detection method for nucleic acid amplification, laboratory confirmed SARS - CoV - 2 adults infected (within 72 hours before delivery) for the first time; Comply with national WeiJianWei "new coronavirus infection pneumonia diagnosis and treatment plan 9 (trial version)" clinical confirmed new coronavirus pneumonia patients (heavy); Agree to sign a consent form to test within 6 months after the effective non-pharmaceutical precautions; 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: In the investigator's judgment, the subject has any physical examination results, laboratory abnormalities, and/or any history of disease that would endanger his safety by participating in the study; Comply with national WeiJianWei "new coronavirus infection pneumonia diagnosis and treatment plan 9 (trial version)" clinical diagnosis of type new coronavirus pneumonia in critically ill patients; Line 4 severe chronic kidney disease, or need dialysis (that is, the estimated glomerular filtration rate (eGFR) < 30 mL/min / 1.73 m2), or within 7 days of the serum creatinine increased 44.2 mu mol/L, or oliguria (< 400 mL / 24 hours) or no urine (< 100 mL / 24 hours); During pregnancy or lactation; Will be moved to within 72 hours is not the another hospital research center; Research on any drug allergies; Used as anticancer drugs, graft rejection drugs or immune regulating biological agents (group into the first 30 days or five half-life [will be subject to a long time]); Long-term use of corticosteroids and oral > 10 mg prednisone, a day for 3 months or more (allow oral every other day 10 mg prednisone); Randomization or research within 2 weeks before treatment and safety shall not be used during the follow-up period live vaccine (live attenuated); At the same time to participate in another clinical research subjects. A washout period of 5 half-lives (depending on the drug under study or 30 days from any previous study, whichever is longer) is required; Total bilirubin (TBL) > 2 x normal limit (ULN), and alanine aminotransferase (ALT) > 5 x ULN, or aspartate amino transferase (AST) > 5 x ULN, or alkaline phosphatase (> 5 x ULN; Platelet < 50 * 109 / L, or hemoglobin < 70 g/L; Researchers say other factors not appropriate in this test. Note: researchers should ensure that participants when screening meets all inclusion/exclusion standard. If a subject's status changes (including laboratory results) between screening and initial dosing and if the subject meets one of the exclusion criteria, the subject shall be excluded from the study.

Sites / Locations

  • First Affiliated Hospital of the Air Force Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Meplzaumb

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

Mortality
All-cause mortality at day 28 (d28)

Secondary Outcome Measures

Full Information

First Posted
January 10, 2023
Last Updated
September 14, 2023
Sponsor
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05679479
Brief Title
Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

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

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Meplzaumb
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
Biological
Intervention Name(s)
Meplazumab for injection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
0.9% normal saline
Primary Outcome Measure Information:
Title
Mortality
Description
All-cause mortality at day 28 (d28)
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 (including 18 and 80 years old), male and female, By PCR detection method for nucleic acid amplification, laboratory confirmed SARS - CoV - 2 adults infected (within 72 hours before delivery) for the first time; Comply with national WeiJianWei "new coronavirus infection pneumonia diagnosis and treatment plan 9 (trial version)" clinical confirmed new coronavirus pneumonia patients (heavy); Agree to sign a consent form to test within 6 months after the effective non-pharmaceutical precautions; 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: In the investigator's judgment, the subject has any physical examination results, laboratory abnormalities, and/or any history of disease that would endanger his safety by participating in the study; Comply with national WeiJianWei "new coronavirus infection pneumonia diagnosis and treatment plan 9 (trial version)" clinical diagnosis of type new coronavirus pneumonia in critically ill patients; Line 4 severe chronic kidney disease, or need dialysis (that is, the estimated glomerular filtration rate (eGFR) < 30 mL/min / 1.73 m2), or within 7 days of the serum creatinine increased 44.2 mu mol/L, or oliguria (< 400 mL / 24 hours) or no urine (< 100 mL / 24 hours); During pregnancy or lactation; Will be moved to within 72 hours is not the another hospital research center; Research on any drug allergies; Used as anticancer drugs, graft rejection drugs or immune regulating biological agents (group into the first 30 days or five half-life [will be subject to a long time]); Long-term use of corticosteroids and oral > 10 mg prednisone, a day for 3 months or more (allow oral every other day 10 mg prednisone); Randomization or research within 2 weeks before treatment and safety shall not be used during the follow-up period live vaccine (live attenuated); At the same time to participate in another clinical research subjects. A washout period of 5 half-lives (depending on the drug under study or 30 days from any previous study, whichever is longer) is required; Total bilirubin (TBL) > 2 x normal limit (ULN), and alanine aminotransferase (ALT) > 5 x ULN, or aspartate amino transferase (AST) > 5 x ULN, or alkaline phosphatase (> 5 x ULN; Platelet < 50 * 109 / L, or hemoglobin < 70 g/L; Researchers say other factors not appropriate in this test. Note: researchers should ensure that participants when screening meets all inclusion/exclusion standard. If a subject's status changes (including laboratory results) between screening and initial dosing and if the subject meets one of the exclusion criteria, the subject shall be excluded from the study.
Facility Information:
Facility Name
First Affiliated Hospital of the Air Force Medical University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuangshuang Liu, Master
Phone
+86 15061133961
Email
lss@pmbp.cn

12. IPD Sharing Statement

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

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