Official Title
A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection
Brief 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.

Completed
Coronavirus Infection

Drug: Selinexor

Participants will receive 20 mg of selinexor.
Other Name: Array

Other: Placebo

Participants will receive 20 mg of placebo matched to selinexor.

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 <92% on room air in last 12 hours or requires >
4 liters per minute (LPM) oxygen by nasal canula, non-rebreather/Ventimask or
high flow nasal canula in order maintain SaO2 ≥92%, PaO2/FiO2 <300 millimeter per
mercury (mm/hg).

- Elevated C-reactive protein (CRP) > 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] < 90 mm Hg, or Diastolic BP
< 60 mm Hg)

- Multiple organ dysfunction/failure

- In the opinion of the investigator, unlikely to survive for at least 48 hours from
screening or anticipate mechanical ventilation within 48 hours.

- Inadequate hematologic parameters as indicated by the following labs:

- Participants with severe neutropenia (ANC <1000 x 10^9/L) or

- Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)

- Inadequate renal and liver function as indicated by the following labs:

- Creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault

- Aspartate transaminase (AST) or alanine transaminase (ALT) > 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Austria
France
Israel
Spain
United Kingdom
United States
Locations

UCLA
Los Angeles, California, United States

Kaiser Permanente Oakland
Oakland, California, United States

UC Davis Health
Sacramento, California, United States

Kaiser Permanente Sacramento
Sacramento, California, United States

Kaiser Permanente San Francisco
San Francisco, California, United States

Miami Cancer Institute at Baptist Health
Miami, Florida, United States

Emory University
Atlanta, Georgia, United States

Advocate Christ Medical Center
Oak Lawn, Illinois, United States

University of Kansas Medical Center
Kansas City, Kansas, United States

Norton Healthcare
Louisville, Kentucky, United States

Boston Medical Center
Boston, Massachusetts, United States

Karmanos
Detroit, Michigan, United States

Michigan Center of Medical Research
Farmington Hills, Michigan, United States

Michigan Center of Medical Research
Royal Oak, Michigan, United States

Columbia University
New York, New York, United States

Weill Cornell Medical College
New York, New York, United States

Levine Cancer Institute-Atrium Health University City
Charlotte, North Carolina, United States

Lehigh Valley Hospital
Allentown, Pennsylvania, United States

Baylor Scott & White Dallas
Dallas, Texas, United States

MultiCare Institute for Research & Innovation (Puget Sound)
Tacoma, Washington, United States

Hospital Hietzing, 2. Medical department - Center for Diagnosis and Therapy of Rheumatic Diseases
Vienna, Austria

CHU Bordeaux
Bordeaux, France

CHU Lyon
Lyon, France

CHU Nantes
Nantes, France

Hadassah MC
Jerusalem, Israel

Hasharon Medical Center
Petah Tiqva, Israel

Sheba Medical Center
Tel HaShomer, Israel

Hospital Universitari Vall d'Hebron
Barcelona, Spain

Servicio de Medicina Interna, Hospital Universitario de Salamanca, Universidad de Salamanca
Salamanca, Spain

Princess Royal University Hospital
Kent, United Kingdom

Kings College Hospital
London, United Kingdom

The Royal Marsden Hospital
London, United Kingdom

University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom

Dayana Michel
Study Director
Karyopharm Therapeutics Inc

Karyopharm Therapeutics Inc
NCT Number
Keywords
Covid-19
SARS-CoV-2
MeSH Terms
Infections
Communicable Diseases
COVID-19
Coronavirus Infections