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

Conditions

• Coronavirus Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  Participants will receive 20 mg of selinexor.
• Placebo — OTHER
  Participants will receive 20 mg of placebo matched to selinexor.

Study Details

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.

Key Dates

Start date

Apr 17, 2020

Status verified

Jan 2023

Primary completion

Oct 5, 2020

Completion

Oct 5, 2020

Study Design

Enrollment

190 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Selinexor 20 mg
  Participants will receive 20 milligram (mg) of selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days).
• Placebo Comparator: Placebo
  Participants will receive 20 mg of placebo matched to selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days).

Primary Outcome Measure

Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale [ Time Frame: Baseline up to Day 14 ]

Locations (20)

Find similar trials in Los Angeles, CA

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