the Safety and Efficacy of Meplazumab in Patients With COVID-19
Status:
Not yet recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, double-blind, randomized, placebo-controlled phase 2/3 clinical study.
Based on the results of the Phase I clinical study, one repeat dose group and one placebo
group are used for the standard treatment of the Novel Coronavirus Pneumonia Protocol (Trial
8) The treatment regimen is a one-time intravenous infusion of either mprozumab or placebo on
day 1 (D1) and day 8 (D8) of the treatment period at a dose of 0.2 mg/kg based on body
weight. An estimated 150 subjects will be randomly assigned to either Meplazumab or placebo
in a 2:1 ratio A short-term efficacy evaluation was performed to determine the efficacy and
safety of Meplazumab in each subject within 14 days of initial administration and a long-term
follow-up evaluation was performed 28 days after initial administration to determine the
safety of Meplazumab.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd