the Safety and Efficacy of Meplazumab in Patients With COVID-19

Covid19 Clinical Trial

Official title:

A Multicenter, Double-blind, Randomized Controlled, add-on Phase 2/3 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05113784
• Other study ID #: MPZ-II-01-CN
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 21, 2022
• Est. completion date: October 8, 2022

Study information

• Verified date: March 2022
• Source: Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, double-blind, randomized, placebo-controlled phase 2/3 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 0.2 mg/kg based on body weight. An estimated 150 subjects will be randomly assigned to either Meplazumab or placebo in a 2:1 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 8, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 years =Subject = 75 years, Male and/or female;
• Clinical confirmation of COVID-19 patients in accordance with novel Coronavirus Diagnosis and Treatment Protocol (Trial Version 8) of the NHC
• Participants must be able to understand and willing to participate in this research, this study and signed informed consent form (if incapacitated subjects, the researchers believe the subjects to the test in its own interests, should be signed by its legal guardian informed consent, or telephone inform consent (recording) and note it in the original medical records and other relevant documents)

Exclusion Criteria:

• Subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent;
• SARS-CoV-2 infection by PCR = 96h;
• Platelet (PLT) < 50×10^9/L, or hemoglobin (HGB) < 60g/L;
• Total bilirubin (TBIL) > 2×ULN (upper limit of normal value), or alanine transferase (ALT), aspartate transferase (AST), alkaline phosphatase (ALP) > 5×ULN;
• glomerular filtration rate (GFR) < 30mL/min·1.73m^2, or serum creatinine increased by 0.5mg/ dL within 7 days, or oliguria (<400mL/24hr), or anuria (<100mL/24hr);
• Pregnant or breast feeding;
• Persons who have family planning or do not agree to use effective non-drug contraceptive measures within 6 months after signing the ICF;
• Subjects participating in another clinical study. There will be a need for washout with 5 half lives depending on the study treatment or 30 days since any previous study, whichever is longer;
• he inestigators concluded that the patients had other reasons for not being eligible for the study.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Meplazumab for Injection
humanized antibody target CD147
• Sterile normal saline (0.9%)
Sterile normal saline (0.9%)

Locations

Country	Name	City	State
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	The Third People's Hospital Of Shenzhen	Shenzhen

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of virus nucleic acid test turning negative	Time of virus nucleic acid test turning negative	up to 14 days
Secondary	Treatment to discharge time	Treatment to discharge time	up to 28 days
Secondary	Evolution of the imaging parameters	Changes from pre-dose baseline in CT	up to day28
Secondary	Assessment of the immune response profile	Immune response profile characterized according immune cells and subsets and CRP.	up to day28
Secondary	Assessment of the biochemistry profile	Change from pre-dose baseline in blood biochemistry:Fbg,Cr,BUN,UA,AST,ALT,g-GT,TBIL,ALB,TP,NA,K,Ca,CL	up to day28
Secondary	Assessment of the cytokines profile	Change from pre-dose baseline in cytokines:IL-1b?IL-6?IL-8?IL-10?IL-17?CCL2?CXCL-1?CXCL-2?IFN-??TNFa?CyPA	up to day28