Status:
COMPLETED
Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
Lead Sponsor:
Karyopharm Therapeutics Inc
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 morbidi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT04349098
Start Date
April 17 2020
End Date
October 5 2020
Last Update
January 20 2023
Active Locations (33)
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1
UCLA
Los Angeles, California, United States, 90095
2
Kaiser Permanente Oakland
Oakland, California, United States, 94612
3
UC Davis Health
Sacramento, California, United States, 95817
4
Kaiser Permanente Sacramento
Sacramento, California, United States, 95825