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Evaluation of Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Participants With Moderate or Severe COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04355676
Recruitment Status : Not yet recruiting
First Posted : April 21, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Brief Summary:
The main purpose of this study is to evaluate the activity, safety and reduction in mortality of two regimens of low dose selinexor (KPT-330) in patients with moderate or severe COVID-19.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Patients With Moderate or Severe COVID-19
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selinexor 40mg
Participants will receive 40 milligram (mg) of selinexor as oral tablets on Days 1 and 3 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
20 mg selinexor oral tablet.
Other Names:
  • KPT-330
  • XPOVIO

Experimental: Selinexor 20mg
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
20 mg selinexor oral tablet.
Other Names:
  • KPT-330
  • XPOVIO




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: Up to 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. Number of Participants with Adverse Events (AE) [ Time Frame: From start of study drug administration up to follow-up (Day 30) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 approved reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent approved testing (by local labs).
  • Currently hospitalized and consented within the first 48 hours of hospitalization.
  • Informed consent provided as above (patients must be dosed with study drug within 12 hours of consent).
  • Has symptoms of moderate or severe COVID-19 as demonstrated by:

Moderate COVID-19:

  1. Currently hospitalized and requiring medical care for COVID-19, and
  2. Peripheral capillary oxygen saturation (SpO2, pulse oximetry) > 94% on room air at screening, and
  3. Radiographic evidence of pulmonary infiltrates

Severe COVID-19:

  1. 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 AND
  2. 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, Oxygen saturation (SpO2) <93% on room air or requires > 2L/minute oxygen by NC in order to maintain SaO2 ≥93%, PaO2/FiO2 <300 millimeter per mercury (mm/hg)

    • Female patients of childbearing potential must have a negative serum pregnancy test at Screening and must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
    • Males who are sexually active must commit to use a highly effective method of contraception while receiving selinexor and for 3 months after the last selinexor dose, or consent to total sexual abstinence (abstinence must occur from enrollment and continue for 3 months after the last selinexor dose).

Exclusion Criteria:

  • Evidence of critical COVID-19 based on:

    1. Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations)
    2. Septic shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg)
    3. 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
  • Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are not permitted.
  • Inadequate hematologic parameters as indicated by the following labs:

    1. Patients with severe neutropenia (ANC <1,000 x 10^9/liter [L]) or
    2. Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)
  • Inadequate renal function as indicated by creatinine clearance (CrCl) <20 milliliter per minute (mL/min) using the formula of Cockcroft and Gault.
  • Inadequate hepatic function defined as AST or ALT > 5x the upper limit of normal OR serum direct bilirubin > 2.5x the upper limit of normal.
  • Hyponatremia defined as sodium < 135 milliequivalents per liter (mEq/L).
  • In the opinion of the Investigator, patients who are below their ideal body weight and would be unduly impacted by changes in their weight.
  • Unable to take oral medication when informed consent is obtained.
  • Patients with a legal guardian or who are incarcerated.
  • Pregnant and breastfeeding women.

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): NCT04355676


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

Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
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Study Director: Dayana Michel Karyopharm Therapeutics Inc
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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT04355676    
Other Study ID Numbers: XPORT-CoV-1002
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 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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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases