Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meplazumab for Injection | Experimental | First dose: 0.2 mg/kg - Day 1; Second dose: 0.2 mg/kg - Day 8 |
|
| Placebo | Placebo Comparator | First dose: control - Day 1; Second dose: control -Day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meplazumab for Injection | Drug | humanized antibody target CD147 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time of virus nucleic acid test turning negative | Time of virus nucleic acid test turning negative | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment to discharge time | Treatment to discharge time | up to 28 days |
| Evolution of the imaging parameters | Changes from pre-dose baseline in CT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hongzhou Lu | Shenzhen Third People's Hospital | Principal Investigator |
| Yinzhong Shen | Shanghai Public Health Clinical Center | Principal Investigator |
| Yingxia Liu | Shenzhen Third People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | China | |||
| The Third People's Hospital Of Shenzhen |
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711810 | meplazumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sterile normal saline (0.9%) |
| Drug |
Sterile normal saline (0.9%) |
|
| up to day28 |
| Assessment of the immune response profile | Immune response profile characterized according immune cells and subsets and CRP. | up to day28 |
| 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 |
| 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-γ、TNFα、CyPA | up to day28 |
| Shenzhen |
| China |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |