Ignite Creation Date:
2024-05-06 @ 6:29 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05679479
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2023-01-10
Brief Title:
Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19
Sponsor:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Organization:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Double-blind Randomized Placebo-controlled Loaded Phase III Study on the Safety and Efficacy of Meplazumab for Injection in Severe Patients With COVID-19
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
According to the covid-19 epidemic situation in China there is few sever covid-19 patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 02 mgkg 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 02 mgkg calculated according to body weight It is expected that 350 subjects will be randomly assigned to Meplazumab or placebo in a 11 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None