Skip to main content
OpenTrials
Completed

NCT Number: NCT05113784

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shanghai Public Health Clinical Center, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

meplazumab for injection

Drug

humanized antibody target CD147

Sterile normal saline (0.9%)

Drug

Sterile normal saline (0.9%)

Primary outcomes

  1. Time of virus nucleic acid test turning negative

    Time frame: up to 14 days

    Time of virus nucleic acid test turning negative

Secondary outcomes

  1. Treatment to discharge time

    Time frame: up to 28 days

    Treatment to discharge time

  2. Evolution of the imaging parameters

    Time frame: up to day28

    Changes from pre-dose baseline in CT

  3. Assessment of the immune response profile

    Time frame: up to day28

    Immune response profile characterized according immune cells and subsets and CRP.

  4. Assessment of the biochemistry profile

    Time frame: up to day28

    Change from pre-dose baseline in blood biochemistry:Fbg,Cr,BUN,UA,AST,ALT,g-GT,TBIL,ALB,TP,NA,K,Ca,CL

  5. Assessment of the cytokines profile

    Time frame: up to day28

    Change from pre-dose baseline in cytokines:IL-1b、IL-6、IL-8、IL-10、IL-17、CCL2、CXCL-1、CXCL-2、IFN-γ、TNFα、CyPA

Sponsors and collaborators

Lead sponsor

Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2021
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.