Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Karyopharm Therapeutics Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection
