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Selinexor in Severe COVID-19
NCT04349098Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2020
- Primary completion
- Oct 2020
- Countries
- 6
- Sponsor
- Karyopharm Therapeutics Inc.
- Modality
- Small Molecules
- Drugs
- selinexor
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, single-blind trial in coronavirus disease 2019 (COVID-19) comparing Selinexor 20 mg with Placebo (2 arms). Primary endpoint: Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale at Day 14. Started Apr 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Selinexor 20 mg
Selinexor 20 mg oral tablet Days 1, 3, 5 per week + SoC
Placebo
Matched Placebo oral tablet Days 1, 3, 5 per week + SoC
03
Who it enrols
Adults currently hospitalized with severe COVID-19 (hypoxia, elevated CRP) who are not critical (no intubation/shock) and have adequate organ function.
04
Endpoints
Primary
Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale
Secondary
Percentage of Participants With at Least a 2-Point Improvement in the Ordinal Scale up to Day 7
Percentage of Participants With at Least a 1-Point Improvement in the Ordinal Scale
Time to Clinical Improvement of 2-points Using Ordinal Scale
Overall Death Rate
Rate of Mechanical Ventilation (RMV)
Rate of Intensive Care Unit (ICU) Admission
Length of Hospitalization
Change From Baseline in C-reactive Protein (CRP) Levels
05
Results
Not all primary endpoints met
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