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

Tang-Du Hospital17 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronavirus Disease 2019 (COVID-19)

Interventions

Meplazumab for InjectionDRUG

humanized MAb against CD147

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tangdu Hospital

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

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.

Time frame: 14 days

Secondary Outcomes

Recovery of body temperature

Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla)

Time frame: 14 days

Recovery of resting respiratory rate

Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min)

Time frame: 14 days

Recovery of SPO2

Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (\>94%)

Time frame: 14 days

Chest CT / chest film changes

Rate of lung imaging recovery

Time frame: 28 days

PaO2 / FiO2

Rate of PaO2 / FiO2 recovery

Time frame: 14 days

Time to reach the isolation release standard

Days to reach the isolation release standard

Time frame: 28 days

Changes of inflammatory immune status

Rate of CRP, D-Dimer test recovery

Time frame: 14 days

Data from ClinicalTrials.gov

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