drugset / Trial / NCT04551898
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19
Timeline
- Start
- 2020-12-02
- Primary completion
- 2021-05-25
- Completion
- 2021-05-25
Outcome
Missed primary endpoint
paper Although nasopharyngeal swab SARS-CoV-2 viral RNA copy number was not significantly decreased compared with placebo PMID 36820098 ↗
registry Placebo vs BGB-DXP593 5 mg/kg; p = 0.4829 NCT04551898 ↗
Publications
- Vega R, Antila M, Perez C, Mookadam M, Xie F, Zhang W, Rizwan A, Yao Z, Rasko JEJ. SARS-CoV-2-neutralising antibody BGB-DXP593 in mild-to-moderate COVID-19: a multicentre, randomised, double-blind, phase 2 trial. EClinicalMedicine. 2023 Mar;57:101832. doi: 10.1016/j.eclinm.2023.101832. Epub 2023 Feb 16.
- 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 | BGB-DXP593 | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | BGB-DXP593 | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | BGB-DXP593 | Monoclonal antibody | 30 mg/kg | Intravenous |