Trials / Completed
CompletedNCT04349098
Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 190 (actual)
- Sponsor
- Karyopharm Therapeutics Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selinexor | Participants will receive 20 mg of selinexor. |
| OTHER | Placebo | Participants will receive 20 mg of placebo matched to selinexor. |
Timeline
- Start date
- 2020-04-17
- Primary completion
- 2020-10-05
- Completion
- 2020-10-05
- First posted
- 2020-04-16
- Last updated
- 2023-01-20
- Results posted
- 2021-11-01
Locations
33 sites across 6 countries: United States, Austria, France, Israel, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04349098. Inclusion in this directory is not an endorsement.