Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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: respiratory rate ≥ 30 breaths/minute (min), heart rate ≥ 125/min, SaO2 <93% on room air or requires > 2 liter (L) oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2 <300 millimeter per mercury (mm/hg).
  • Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. If in the physician's judgement, 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) > 2.5 x upper limit of normal (ULN)
  • Total bilirubin >1.5 x upper limit of normal (ULN)
  • Hyponatremia defined as sodium < 135 milliequivalents per litre (mEq/L).
  • Unable to take oral medication when informed consent is obtained.
  • Treatment with strong CYP3A inhibitors or inducers.
  • Pregnant and breastfeeding women.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Selinexor 20 mg
Participants will receive 20 milligram (mg) of selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days).
  • Drug: Selinexor
    Participants will receive 20 mg of selinexor.
    Other names:
    • KPT-330
    • XPOVIO
Placebo Comparator
Placebo
Participants will receive 20 mg of placebo matched to selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days).
  • Other: Placebo
    Participants will receive 20 mg of placebo matched to selinexor.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118

More Details

Status
Recruiting
Sponsor
Karyopharm Therapeutics Inc

Study Contact

Jatin Shah, Chief Medical Officer
(617) 658-0600
jshah@karyopharm.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.