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NCT04349098 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
A Phase 2 study, sponsored by Karyopharm Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 190
- Enrollment target
NCT04349098: Completed Phase 2 study, sponsored by Karyopharm Therapeutics.
NCT04349098 is a Phase 2 study that has completed, run by Karyopharm Therapeutics. The registered enrollment target is 190 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04349098, a Phase 2 study, has completed, sponsored by Karyopharm Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 190 participants
- Enrollment target
Study 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.
Primary Outcome
Ordinal Scale 2-Point improvement was defined as percentage of participants with at least a 2-points improvement (increase from baseline) by Day 14. Baseline score was defined as the last score measured before first dosing. The 8-point ordinal scale ranges from 1 to 8: where 1= death, 2= hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental o
Interventions
- OTHER Placebo
- DRUG Selinexor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2020-04-17 |
| Est. Completion | 2020-10-05 |
| Phase | Phase 2 |
What the finished NCT04349098 record still lists
NCT04349098 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04349098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04349098 about?
NCT04349098 is a clinical study titled "Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection". 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 ...
What is the current status of trial NCT04349098?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2020-04-17. Estimated completion is 2020-10-05.
What interventions are being tested in trial NCT04349098?
The interventions under investigation include: Placebo (OTHER), Selinexor (DRUG).
Who is sponsoring clinical trial NCT04349098?
This trial is sponsored by Karyopharm Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04349098's enrollment target sits among peer trials
190 353rd of 2000 higher than 1,646 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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