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This is a multicenter, double-blind, randomized, placebo-controlled, loaded Phase III clinical study. This test is in a new coronavirus infection pneumonia diagnosis and treatment plan of 9 (trial version) "(SoC), on the basis of the standard treatments according to the results of clinical studies have been obtained, using a dose of 0.2 mg/kg, and a placebo. The regimen consisted of a single intravenous infusion of Meplazumab or placebo on day 1 (d0) of the treatment period and d7 after initial administration at a dose of 0.2 mg/kg calculated according to body weight. It is expected that 350 subjects will be randomly assigned to Meplazumab or placebo in a 1:1 ratio. Short-term efficacy evaluation was performed for each subject within 28 days after initial administration to determine the therapeutic efficacy and safety of Meplazumab. Long-term follow-up evaluation was performed within 56 days of initial administration to determine the safety of Meplazumab in each subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meplzaumb | 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 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | All-cause mortality at day 28 (d28) | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
Note: researchers should ensure that participants when screening meets all inclusion/exclusion standard. If a subject's status changes (including laboratory results) between screening and initial dosing and if the subject meets one of the exclusion criteria, the subject shall be excluded from the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of the Air Force Medical University | Xi'an | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40222976 | Derived | Bian H, Chen L, Zhang Z, Wen AD, Zheng ZH, Song LQ, Yao MY, Liu YX, Zhang XJ, Dong HL, Lian JQ, Pan L, Liu Y, Gu X, Zhao H, Wang JW, Wang QY, Zhang K, Jia JF, Xie RH, Luo X, Fu XH, Jia YY, Hou JN, Tan QY, Chen XX, Yang LQ, Lin YL, Wang XX, Zhang L, Zeng QJ, Li WJ, Wang RX, Zhang Y, Sun XX, Wang B, Yang X, Jiang JL, Li L, Wu J, Yang XM, Zhang H, Shi Y, Chen XC, Tang H, Shi HW, Liu SS, Yang Y, Yang TY, Wei D, Chen ZN, Zhu P. Meplazumab, a CD147 antibody, for severe COVID-19: a double-blind, randomized, placebo-controlled, phase 3 clinical trial. Signal Transduct Target Ther. 2025 Apr 14;10(1):119. doi: 10.1038/s41392-025-02208-9. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000711810 | meplazumab |
| D007267 | Injections |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000077324 | Crystalloid Solutions |
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|
| Normal saline | Other | 0.9% normal saline |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007552 |
| Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |