Phase 2
Completed N=190
Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
Source: ClinicalTrials.gov NCT04349098 ↗Enrolled (actual)
190
Serious AEs
19.7%
Results posted
Nov 2021
Primary outcomePrimary: Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale — 60.6; 60.8 Percentage of participants — p=0.6750
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale |
60.6; 60.8 | 0.6750 |
| SECONDARY Percentage of Participants With at Least a 2-Point Improvement in the Ordinal Scale up to Day 7 |
30.1; 32.2 | — |
| SECONDARY Percentage of Participants With at Least a 1-Point Improvement in the Ordinal Scale |
51.5; 50.6; 72.8; 72.4 | — |
| SECONDARY Time to Clinical Improvement of 2-points Using Ordinal Scale (TTCI-2) |
10.0; 10.0 | — |
| SECONDARY Overall Death Rate |
15.2; 3.9 | — |
| SECONDARY Rate of Mechanical Ventilation (RMV) |
13.6; 11.8 | — |
| SECONDARY Rate of Intensive Care Unit (ICU) Admission |
48.5; 41.2 | — |
| SECONDARY Length of Hospitalization |
9.0; 9.0 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) Levels |
-47.9660; -42.9658; -74.4735; -68.6191; -83.3460; -74.4669 | — |
| SECONDARY Change From Baseline in Ferritin Levels |
80.8415; -61.9843; -25.7000; -155.3111; 226.6113; -292.2462 | — |
| SECONDARY Change From Baseline in Lactate Dehydrogenase (LDH) Levels |
-13.86; -11.86; -49.12; 31.85; -75.85; -10.93 | — |
| SECONDARY Changes From Baseline in Blood Plasma Cytokines Levels-Interleukin-6 (IL-6) |
-19.931; 2.046; -10.786; -77.509; -13.909; 183.728 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
75; 49; 23; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent FDA-approved testing (local labs).
- Currently hospitalized.
- Informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent).
- Has symptoms of severe COVID-19 as demonstrated by:
- At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress.
- Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: SaO2 4 liters per minute (LPM) oxygen by nasal canula, non-rebreather/Ventimask or high flow nasal canula in order maintain SaO2 ≥92%, PaO2/FiO2 2 x upper limit of normal (ULN).
- Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. If in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form.
- Female participants of childbearing potential must have a negative serum pregnancy test at Screening. Female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
Exclusion Criteria
- Evidence of critical COVID-19 based on:
- Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations)
- Septic shock (defined by Systolic blood pressure [BP] 5 x ULN
- Hyponatremia defined as sodium < 135 milliequivalents per liter (mEq/L).
- Unable to take oral medication when informed consent is obtained.
- Participants with a legal guardian or who are incarcerated.
- Treatment with strong CYP3A inhibitors or inducers.
- Pregnant and breastfeeding women.
Data sourced from ClinicalTrials.gov (NCT04349098). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.