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To evaluate the safety and efficacy of humanized Meplazumab for Injection in patients infected by 2019-nCoA.
According to the results of nonclinical study of humanized Meplazumab for Injection, a single dose will be used for the treatment. The treatment plan is first dose on the first day (0d) and second dose on the second day (1D) of the treatment period by intravenous(IV) infusion, each dose 10mg; The third dose will be given within 3-5 days after the second dose according to the patient's 2019-nCoV nucleic acid load, clinical manifestations and the overall evaluation of doctors, dose is 10mg. 30 mg of methylprednisolone will be given intravenously 30 minutes before each administration. Each subject will be evaluated the therapeutic effect within 28 days after the first administration, and to determine the preliminary therapeutic effect, safety and tolerability of humanized Meplazumab for Injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meplazumab | Experimental | 10mg Meplazumab by intravenous infusion, every day for 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meplazumab for Injection | Drug | humanized MAb against CD147 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2019 nCoV nucleic acid detection | Virological clearance rate using Real-Time PCR in upper and/or lower respiratory tract samples at day 3, day 7 and day 14 respectively. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of body temperature | Time (days) from initiation of Meplazumab treatment until normalization of body temperature (≤37℃ axilla) | 14 days |
| Recovery of resting respiratory rate | Time (days) from initiation of Meplazumab treatment until normalization of resting respiratory rate (≤24/min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000711810 | meplazumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 14 days |
| Recovery of SPO2 | Time (days) from initiation of Meplazumab treatment until normalization of SPO2 (>94%) | 14 days |
| Chest CT / chest film changes | Rate of lung imaging recovery | 28 days |
| PaO2 / FiO2 | Rate of PaO2 / FiO2 recovery | 14 days |
| Time to reach the isolation release standard | Days to reach the isolation release standard | 28 days |
| Changes of inflammatory immune status | Rate of CRP, D-Dimer test recovery | 14 days |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |