drugset / Trial / NCT04586153
Study to Assess the Effect of Meplazumab on COVID-19
RandomizedParallel-groupDouble-blindTreatment
Summary
This phase2/3 study will be conducted to evaluate the safety and efficacy of Meplazumab in addition to Standard of Care for the treatment of Corona Virus Disease(COVID) 19 in hospitalized adults
Timeline
- Start
- 2021-02-15
- Primary completion
- 2022-12-02
- Completion
- 2022-12-18
Publications
- Bian H, Chen L, Zheng ZH, Sun XX, Geng JJ, Chen R, Wang K, Yang X, Chen SR, Chen SY, Xie RH, Zhang K, Miao JL, Jia JF, Tang H, Liu SS, Shi HW, Yang Y, Chen XC, Malhotra V, Nasir N, Khanum I, Mahmood F, Hamid S, Stadnik CMB, Itinose K, de Oliveira CCC, Dusilek C, Rivabem L, Cavalcante AJW, Lopes SS, Saporito WF, Fucci FJC, Simon-Campos JA, Wang L, Liu LN, Wang QY, Wei D, Zhang Z, Chen ZN, Zhu P. Meplazumab in hospitalized adults with severe COVID-19 (DEFLECT): a multicenter, seamless phase 2/3, randomized, third-party double-blind clinical trial. Signal Transduct Target Ther. 2023 Jan 30;8(1):46. doi: 10.1038/s41392-023-01323-9.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meplazumab | Monoclonal antibody | 0.12 mg/kg | — |
| Subject | Meplazumab | Monoclonal antibody | 0.2 mg/kg | — |
| Subject | Meplazumab | Monoclonal antibody | 0.3 mg/kg | — |