Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
Summary
The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world.
Timeline
- Start
- 2020-04-17
- Primary completion
- 2020-10-05
- Completion
- 2020-10-05
Outcome
Missed primary endpoint
registry analysis (superiority test); Selinexor 20 mg vs Placebo; p = 0.6750; Odds Ratio (OR) 0.84 (95% CI 0.39 to 1.79) NCT04349098 ↗
release “NCT04349098). While an interim analysis indicated that the trial was unlikely to meet its pre-specified primary endpoint” karyopharm.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Selinexor | Other / unclassified | 20 mg | Oral |