The main purpose of this study is to evaluate the activity, safety and reduction in mortality of two regimens of low dose selinexor (KPT-330) in patients with moderate or severe COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
20 mg selinexor oral tablet.
Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale
Time frame: Baseline to Day 14
Time to Clinical Improvement (TTCI)
Time frame: Up to Day 28
Overall Death Rate
Time frame: Day 14, Day 28
Rate of Mechanical Ventilation
Time frame: Up to Day 28
Time to Mechanical Ventilation
Time frame: Up to Day 28
Overall Survival
Time frame: Up to Day 28
Time to Improvement (2 points) in Clinical Measures Using the Ordinal Scale
Time frame: Up to Day 28
Time to Intensive Care Unit (ICU) Admission
Time frame: Up to Day 28
Rate of Intensive Care Unit (ICU) Admission
Time frame: Up to Day 28
Length of Stay in Hospital
Time frame: Up to Day 28
Percentage of Participants Discharged From Hospital
Time frame: Up to Day 28
Length of Stay in Intensive Care Unit (ICU)
Time frame: Up to Day 28
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Duration of Oxygen Supplementation
Time frame: Up to Day 28
Duration of Mechanical Ventilation
Time frame: Up to Day 28
Time to Clinical Improvement in Participants ≤ 70 Years Old
Time frame: Up to Day 28
Time to Clinical Improvement in Participants > 70 Years Old
Time frame: Up to Day 28
Time to Clinical Improvement in Participants with Pre-existing Diseases
Time frame: Up to Day 28
Change in Oxygenation Index
Time frame: Up to Day 28
Time to Improvement of One Point Using WHO Ordinal Scale Improvement
Time frame: Up to Day 28
Percentage of Participants Experiencing WHO Ordinal Scale Improvement of >1 point
Time frame: Up to Day 28
Change from Baseline in C-reactive protein (CRP) Levels
Time frame: Up to Day 28
Change from Baseline in Ferritin Levels
Time frame: Up to Day 28
Change from Baseline in Lactate Dehydrogenase (LDH) Levels
Time frame: Up to Day 28
Number of Participants with Adverse Events (AE)
Time frame: From start of study drug administration up to follow-up (Day 30)