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

Phase 1

Completed

• Conditions: Coronavirus Disease 2019 (COVID-19)
• Interventions: Drug: Meplazumab for Injection

• Registration Number: NCT04275245
• Lead Sponsor: Tang-Du Hospital

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2020-02-03
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-16
• Study First Posted: 2020-02-19
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-07
• Last Update Posted: 2021-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meplazumab	Meplazumab for Injection	10mg Meplazumab by intravenous infusion, every day for 2 days

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China