Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19

Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
This is a multicenter, double‐blind, randomized, placebo‐controlled, loaded Phase III clinical study. This test is in a new coronavirus infection pneumonia diagnosis and treatment plan of 9 (trial version) "(SoC), on the basis of the standard treatments according to the results of clinical studies have been obtained, using a dose of 0.2 mg/kg, and a placebo. The regimen consisted of a single intravenous infusion of Meplazumab or placebo on day 1 (d0) of the treatment period and d7 after initial administration at a dose of 0.2 mg/kg calculated according to body weight. It is expected that 350 subjects will be randomly assigned to Meplazumab or placebo in a 1:1 ratio. Short‐term efficacy evaluation was performed for each subject within 28 days after initial administration to determine the therapeutic efficacy and safety of Meplazumab. Long‐term follow‐up evaluation was performed within 56 days of initial administration to determine the safety of Meplazumab in each subject.
Epistemonikos ID: 61434e17a76162bee33ba55ad9038a72d72f4610
First added on: Jan 12, 2023