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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-blind, Randomized Controlled, add-on Phase 2/3 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19

Conditions
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Covid19

Intervention / Treatment
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* Drug: Meplazumab for Injection
* Drug: Sterile normal saline (0.9%)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |