A Study to Evaluate the Effect of RBT-9 on Progression of COVID-19 in High-Risk Individuals (The PREVENT Study)
Summary
The overall objective is to evaluate the efficacy, tolerability, and safety of a single dose of RBT-9 versus placebo in coronavirus disease 2019 (COVID-19) infection in non-critically ill adults who are at high risk of progression.
Timeline
- Start
- 2020-08-05
- Primary completion
- 2021-09-02
- Completion
- 2021-09-30
Outcome
Mixed primary results
Stopped (Enrollment): “Enrollment feasibility”
registry LEAST_SQUARES_MEAN RBT-9 (90 mg): Day 7: -1.0 (-1.6 to -0.5) units on a scale NCT04364763 ↗
registry analysis (superiority test); RBT-9 (90 mg) vs Placebo; p = 0.0352; Mixed Models Analysis; note: p-value is for Day 7 NCT04364763 ↗
registry LEAST_SQUARES_MEAN RBT-9 (90 mg): Day 28: -1.2 (-1.8 to -0.7) units on a scale NCT04364763 ↗
registry analysis (superiority test); RBT-9 (90 mg) vs Placebo; p = 0.2350; Mixed Models Analysis; note: p-value is for Day 28 NCT04364763 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RBT-9 | Small molecule | 90 mg | Intravenous |