Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection (Coronavirus)
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04349098 |
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Recruitment Status :
Completed
First Posted : April 16, 2020
Last Update Posted : December 24, 2020
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Sponsor:
Karyopharm Therapeutics Inc
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 202 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 |
| Actual Primary Completion Date : | October 5, 2020 |
| Actual Study Completion Date : | October 5, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Coronavirus Infections
Drug Information available for:
Selinexor
| Arm | Intervention/treatment |
|---|---|
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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).
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Drug: Selinexor
Participants will receive 20 mg of selinexor.
Other Names:
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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).
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Other: Placebo
Participants will receive 20 mg of placebo matched to selinexor. |
Primary Outcome Measures :
- Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale [ Time Frame: Baseline to Day 14 ]
Secondary Outcome Measures :
- Time to Clinical Improvement (TTCI) [ Time Frame: Up to Day 28 ]
- Overall Death Rate [ Time Frame: Day 14, Day 28 ]
- Rate of Mechanical Ventilation [ Time Frame: Up to Day 28 ]
- Time to Mechanical Ventilation [ Time Frame: Up to Day 28 ]
- Overall Survival [ Time Frame: Up to Day 28 ]
- Time to Improvement (2 points) in Clinical Measures Using the Ordinal Scale [ Time Frame: Baseline, Day 28 ]
- Time to Intensive Care Unit (ICU) Admission [ Time Frame: Up to Day 28 ]
- Rate of Intensive Care Unit (ICU) Admission [ Time Frame: Up to Day 28 ]
- Length of Stay in Hospital [ Time Frame: Up to Day 28 ]
- Percentage of Participants Discharged from Hospital [ Time Frame: Up to Day 28 ]
- Length of Stay in Intensive Care Unit (ICU) [ Time Frame: Up to Day 28 ]
- Duration of Oxygen Supplementation [ Time Frame: Up to Day 28 ]
- Duration of Mechanical Ventilation [ Time Frame: Up to Day 28 ]
- Time to Clinical Improvement in Participants ≤ 70 Years Old [ Time Frame: Up to Day 28 ]
- Time to Clinical Improvement in Participants > 70 Years Old [ Time Frame: Up to Day 28 ]
- Time to Clinical Improvement in Participants with Pre-existing Diseases [ Time Frame: Up to Day 28 ]
- Change in Oxygenation Index [ Time Frame: Up to Day 28 ]
- Time to Improvement of One Point Using WHO Ordinal Scale Improvement [ Time Frame: Up to Day 28 ]
- Percentage of Participants Experiencing WHO Ordinal Scale Improvement of >1 point [ Time Frame: Up to Day 28 ]
- Change from Baseline in C-reactive protein (CRP) Levels [ Time Frame: Up to Day 28 ]
- Change from Baseline in Ferritin Levels [ Time Frame: Up to Day 28 ]
- Change from Baseline in Lactate Dehydrogenase (LDH) Levels [ Time Frame: Up to Day 28 ]
- Changes from Baseline in Blood Plasma Cytokines Levels [ Time Frame: Up to Day 28 ]
- Number of Participants with Adverse Events (AE) [ Time Frame: From start of study drug administration up to Day 28 ]
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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).
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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:
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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.
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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)
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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.
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
Locations
Show 33 study locations
Sponsors and Collaborators
Karyopharm Therapeutics Inc
Investigators
| Study Director: | Dayana Michel | Karyopharm Therapeutics Inc |
| 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: | December 24, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Karyopharm Therapeutics Inc:
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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 |