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

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ClinicalTrials.gov Identifier: NCT04349098
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronavirus Infection Drug: Selinexor Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : April 17, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale [ Time Frame: Baseline to Day 14 ]

Secondary Outcome Measures :
  1. Time to Clinical Improvement (TTCI) [ Time Frame: Up to Day 28 ]
  2. Overall Death Rate [ Time Frame: Day 14, Day 28 ]
  3. Rate of Mechanical Ventilation [ Time Frame: Up to Day 28 ]
  4. Time to Mechanical Ventilation [ Time Frame: Up to Day 28 ]
  5. Overall Survival [ Time Frame: Up to Day 28 ]
  6. Time to Improvement (2 points) in Clinical Measures Using the Ordinal Scale [ Time Frame: Baseline, Day 28 ]
  7. Time to Intensive Care Unit (ICU) Admission [ Time Frame: Up to Day 28 ]
  8. Rate of Intensive Care Unit (ICU) Admission [ Time Frame: Up to Day 28 ]
  9. Length of Stay in Hospital [ Time Frame: Up to Day 28 ]
  10. Percentage of Participants Discharged from Hospital [ Time Frame: Up to Day 28 ]
  11. Length of Stay in Intensive Care Unit (ICU) [ Time Frame: Up to Day 28 ]
  12. Duration of Oxygen Supplementation [ Time Frame: Up to Day 28 ]
  13. Duration of Mechanical Ventilation [ Time Frame: Up to Day 28 ]
  14. Time to Clinical Improvement in Participants ≤ 70 Years Old [ Time Frame: Up to Day 28 ]
  15. Time to Clinical Improvement in Participants > 70 Years Old [ Time Frame: Up to Day 28 ]
  16. Time to Clinical Improvement in Participants with Pre-existing Diseases [ Time Frame: Up to Day 28 ]
  17. Change in Oxygenation Index [ Time Frame: Up to Day 28 ]
  18. Time to Improvement of One Point Using WHO Ordinal Scale Improvement [ Time Frame: Up to Day 28 ]
  19. Percentage of Participants Experiencing WHO Ordinal Scale Improvement of >1 point [ Time Frame: Up to Day 28 ]
  20. Change from Baseline in C-reactive protein (CRP) Levels [ Time Frame: Up to Day 28 ]
  21. Change from Baseline in Ferritin Levels [ Time Frame: Up to Day 28 ]
  22. Change from Baseline in Lactate Dehydrogenase (LDH) Levels [ Time Frame: Up to Day 28 ]
  23. Changes from Baseline in Blood Plasma Cytokines Levels [ Time Frame: Up to Day 28 ]
  24. Number of Participants with Adverse Events (AE) [ Time Frame: From start of study drug administration up to Day 28 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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: 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349098


Contacts
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Contact: Jatin Shah, Chief Medical Officer (617) 658-0600 jshah@karyopharm.com
Contact: Sharon Shacham, President and CSO (617) 658-0600 sshacham@karyopharm.com

Locations
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Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
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Study Director: Dayana Michel Karyopharm Therapeutics Inc
More Information
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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT04349098    
Other Study ID Numbers: XPORT-CoV-1001
2020-001411-25 ( EudraCT Number )
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karyopharm Therapeutics Inc:
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases