A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19
Summary
The purpose of this study is to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID-19 in adult ambulatory patients.
Timeline
- Start
- 2021-05-10
- Primary completion
- 2021-11-18
- Completion
- 2022-01-27
Outcome
Met primary endpoint
Stopped: “Phase 2 completed as planned. Due to the evolving landscape of treatments for COVID-19, the placebo-controlled Phase 3 design will not proceed. No patients were actively participating at the time of termination.”
registry analysis (superiority test); Ensovibep 600 mg vs Placebo; p <0.001; Least square (LS) mean difference -0.59 (95% CI -0.86 to -0.32); ANCOVA NCT04828161 ↗
registry analysis (superiority test); Ensovibep 225 mg vs Placebo; p = 0.014; LS mean difference -0.33 (95% CI -0.60 to -0.07); ANCOVA NCT04828161 ↗
registry analysis (superiority test); Ensovibep 75 mg vs Placebo; p = 0.002; LS mean difference -0.42 (95% CI -0.68 to -0.15); ANCOVA NCT04828161 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ensovibep | Protein / enzyme biologic | — | Intravenous |