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

Completed · Phase 2 · Has a placebo group

Conditions studied: Coronavirus Infection

In brief

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 facts

Study ID

NCT04349098

Run by

Karyopharm Therapeutics Inc

People needed

190

Starts

2020-04-17

Expected to finish

2020-10-05

Last updated by the study team

2023-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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