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Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection

NCT04349098 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2023-01-20

Study results available
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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

  • Coronavirus Infection

Interventions

DRUG

Selinexor

Participants will receive 20 mg of selinexor.

OTHER

Placebo

Participants will receive 20 mg of placebo matched to selinexor.

Sponsors & Collaborators

  • Karyopharm Therapeutics Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2020-10-05
Completion
2020-10-05
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Israel
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04349098 on ClinicalTrials.gov