NCT04275245

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronavirus Disease 2019 (COVID-19)

Interventions

Type	Name	Description
DRUG	Meplazumab for Injection	humanized MAb against CD147

Timeline

• Start date: 2020-02-03
• Primary completion: 2020-03-09
• Completion: 2020-03-09
• First posted: 2020-02-19
• Last updated: 2021-04-09

Locations

1 site across 1 country: China