Ignite Creation Date:
2024-05-06 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05113784
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2021-09-17
Brief Title:
the Safety and Efficacy of Meplazumab in 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 Controlled add-on Phase 23 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 phase 23 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 02 mgkg based on body weight An estimated 150 subjects will be randomly assigned to either Meplazumab or placebo in a 21 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
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