Clinical Study of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.

Detailed Description
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According to the results of nonclinical study of humanized Meplazumab for Injection, a single dose will be used for the treatment. The treatment plan is first dose on the first day (0d) and second dose on the second day (1D) of the treatment period by intravenous(IV) infusion, each dose 10mg; The third dose will be given within 3-5 days after the second dose according to the patient's 2019-nCoV nucleic acid load, clinical manifestations and the overall evaluation of doctors, dose is 10mg. 30 mg of methylprednisolone will be given intravenously 30 minutes before each administration. Each subject will be evaluated the therapeutic effect within 28 days after the first administration, and to determine the preliminary therapeutic effect, safety and tolerability of humanized Meplazumab for Injection.

Official Title
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Single Center, Single Arm, Open Clinical Study to Access Safety and Initial Efficacy of Anti-CD147 Humanized Meplazumab for Injection to Treat With 2019-nCoV Pneumonia

Conditions
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Coronavirus Disease 2019 (COVID-19)

Intervention / Treatment
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* Drug: Meplazumab for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18 to 75 years (inclusive) In line with the new coronavirus infection pneumonia diagnosis and treatment plan (trial version 4) issued by the Health Commission, patients with new coronavirus (2019 ncov) pneumonia were clinically diagnosed; The subjects must be able to understand the study and willing to participate in the study, and sign the informed consent (if the subjects with no behavioral ability think it is in their own interests to participate in the test, they should sign the informed consent by their legal guardian, or notify the consent by phone (recording) and explain it in the original medical record and other relevant documents). Exclusion Criteria: Known or expected to have allergic reactions or a history of allergy to any of the ingredients treated in this trial; In the judgment of the investigator, there are other reasons that the patient is not suitable to participate in this 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meplazumab<br>10mg Meplazumab by intravenous infusion, every day for 2 days | Drug: Meplazumab for Injection<br>* humanized MAb against CD147<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2019 nCoV nucleic acid detection | Virological clearance rate using Real-Time PCR in upper and/or lower respiratory tract samples at day 3, day 7 and day 14 respectively. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of body temperature | Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla) | 14 days | 
| Recovery of resting respiratory rate | Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min) | 14 days | 
| Recovery of SPO2 | Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%) | 14 days | 
| Chest CT / chest film changes | Rate of lung imaging recovery | 28 days | 
| PaO2 / FiO2 | Rate of PaO2 / FiO2 recovery | 14 days | 
| Time to reach the isolation release standard | Days to reach the isolation release standard | 28 days | 
| Changes of inflammatory immune status | Rate of CRP, D-Dimer test recovery | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, pneumonia