Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813587
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2023-04-10
Brief Title:
To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19
Sponsor:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Organization:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Loaded Phase III Clinical Trial on the Efficacy and Safety of Mepozumab for Injection in the Treatment of Post-COVID-19
Status:
COMPLETED
Status Verified Date:
2024-02
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 trial was a randomized double-blind placebo-controlled loading phase III clinical study
Detailed Description:
This test is in the new type of coronavirus infection therapy and 10 trial version and new coronavirus pneumonia antiviral drug clinical trial technical guidelines try out on the basis of according to the results of the phase I and phase II clinical study to set up an experimental group and a placebo group experimental group on the basis of medicines for load test The control group was loaded with placebo as the base treatment A planned cohort of 144 patients with Post-COVID-19 120 20 dropped out was randomly assigned in a 11 ratio to the experimental group or the placebo group Mepozumab or placebo was intravenously infused at a dose of 02 mgkg on day 1 D0 If the clinical symptoms of Post-COVID-19 were not relieved remission was defined as a decrease in the Post-COVID-19 composite score for at least 2 days an additional dose of 02 mgkg was administered on day 7 after the first dose and the actual dose was calculated according to the body weight of the subject The participants were asked to record the clinical symptoms of Post-COVID-19 daily during the trial The absent clinical symptoms were evaluated as zero none and the present clinical symptoms were recorded until they returned to normal score zero which lasted for at least 2 days On the 28th day D283 after the first dose the subjects were required to return to the study center again return their diary cards and complete each exit examination If a participant stops the trial early for various reasons laboratory testing is required to complete the efficacy and safety assessment During the trial the subjects were treated according to the type and severity of adverse events according to the clinical diagnosis and treatment standards
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