Study on the Safety and Efficacy of Meplazumab for Injection in Severe 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, 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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Meplazumab for injection
* Other: Normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 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: Meplzaumb<br>First dose: 0.2 mg/kg - Day 1; second dose: 0.2 mg/kg - Day 8 | Biological: Meplazumab for injection<br>* 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.<br>|
| Placebo Comparator: Placebo<br>First dose: control - Day 1; second dose: control - Day 8 | Other: Normal saline<br>* 0.9% normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause mortality at day 28 (d28) | Day 28 |