Ignite Creation Date:
2024-05-06 @ 3:17 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04586153
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2020-10-12
Brief Title:
Study to Assess the Effect of Meplazumab on COVID-19
Sponsor:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Organization:
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Seamless Randomized Third-Party-Blind Clinical Trial to Evaluate the Safety and Efficacy of Meplazumab in Addition to Standard of Care for the Treatment of COVID-19 in Hospitalized Adults
Status:
COMPLETED
Status Verified Date:
2022-05
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 phase23 study will be conducted to evaluate the safety and efficacy of Meplazumab in addition to Standard of Care for the treatment of Corona Virus DiseaseCOVID 19 in hospitalized adults
Detailed Description:
1 Rationale
Meplazumab is a humanized anti-CD147 immunoglobulin 2 IgG2 monoclonal antibody which is expected to block the binding of the severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 spike protein to the human host-cell-expressed CD147 thereby blocking entry of SARS-CoV-2 into human tissue This expectation is based on in vitro functional studies using Vero E6 cells infected with SARS-CoV-2 that demonstrated effective meplazumab mediated virus gene copy number inhibition upwards of 90 as evaluated by quantitative polymerase chain reaction Meplazumab may also inhibit COVID-19 associated cytokine storm syndrome based on inhibition of the pro inflammatory factor Cyclophilin A host-cell CD147 interaction
2 Overall Design
This is a multicenter seamless randomized third-party-blind study to evaluate the safety and efficacy of meplazumab for the treatment of COVID 19 in hospitalized adults 18 years Neither the subject nor the investigator shall be aware of the study drug identity as the study drug is dispensed by a third party eg a pharmacist or nurse
Enrollment of subjects will be stopped once the total number of planned subjects have completed the Stage 1 Day 29 visit procedures Once the interim analysis of Stage 1 study data is complete and the Independent Data Monitoring Committee IDMC has recommended the meplazumab dose that is safe and effective to carry forward into Stage 2 the study will resume subject enrollment A summary of the key Stage 1 interim analysis results will be sent to the relevant Health Authorities involved if requested
3 Number of Investigators and Study Centers
There will be 15 to 20 Investigators at 12 to 20 study centers globally participating in this study
4 Number of Subjects
Subjects will be screened 1 day before randomization Stage 1 Approximately 168 subjects will be randomized and allocated 1111 42424242 to receive meplazumab low dose meplazumab medium dose meplazumab high dose or control An interim analysis will be conducted to select the optimal dose of meplazumab compared with the control group based on response rates of clinical improvement at Day 29
Stage 2 276 more subjects will be randomized and allocated 11 138138 to receive 02mgkg meplazumab or control At interim analysis primary endpoint sample size calculation for Stage 2 will be re evaluated based on the observed outcomes at Stage 1 and will be capped at 300 subjects total
5 Treatment Groups and Duration
Study duration for each subject will be 847 days from randomization in each stage
Meplazumab is a humanized anti-CD147 immunoglobulin 2 IgG2 monoclonal antibody which is expected to block the binding of the severe acute respiratory syndrome coronavirus 2 SARS-CoV-2 spike protein to the human host-cell-expressed CD147 thereby blocking entry of SARS-CoV-2 into human tissue This expectation is based on in vitro functional studies using Vero E6 cells infected with SARS-CoV-2 that demonstrated effective meplazumab mediated virus gene copy number inhibition upwards of 90 as evaluated by quantitative polymerase chain reaction Meplazumab may also inhibit COVID-19 associated cytokine storm syndrome based on inhibition of the pro inflammatory factor Cyclophilin A host-cell CD147 interaction
2 Overall Design
This is a multicenter seamless randomized third-party-blind study to evaluate the safety and efficacy of meplazumab for the treatment of COVID 19 in hospitalized adults 18 years Neither the subject nor the investigator shall be aware of the study drug identity as the study drug is dispensed by a third party eg a pharmacist or nurse
Enrollment of subjects will be stopped once the total number of planned subjects have completed the Stage 1 Day 29 visit procedures Once the interim analysis of Stage 1 study data is complete and the Independent Data Monitoring Committee IDMC has recommended the meplazumab dose that is safe and effective to carry forward into Stage 2 the study will resume subject enrollment A summary of the key Stage 1 interim analysis results will be sent to the relevant Health Authorities involved if requested
3 Number of Investigators and Study Centers
There will be 15 to 20 Investigators at 12 to 20 study centers globally participating in this study
4 Number of Subjects
Subjects will be screened 1 day before randomization Stage 1 Approximately 168 subjects will be randomized and allocated 1111 42424242 to receive meplazumab low dose meplazumab medium dose meplazumab high dose or control An interim analysis will be conducted to select the optimal dose of meplazumab compared with the control group based on response rates of clinical improvement at Day 29
Stage 2 276 more subjects will be randomized and allocated 11 138138 to receive 02mgkg meplazumab or control At interim analysis primary endpoint sample size calculation for Stage 2 will be re evaluated based on the observed outcomes at Stage 1 and will be capped at 300 subjects total
5 Treatment Groups and Duration
Study duration for each subject will be 847 days from randomization in each stage
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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