Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA
Dates
study started
estimated completion
Principal Investigator
by Otto Yang (ucla)George Thompson (ucdavis)

Description

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.

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

Keywords

Coronavirus Infection COVID-19 SARS-CoV-2 Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Selinexor Selinexor 20 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join 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 109/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.

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • UC Davis Health accepting new patients
    Sacramento California 95817 United States
  • Kaiser Permanente San Francisco accepting new patients
    San Francisco California 94115 United States
  • Kaiser Permanente Oakland accepting new patients
    Oakland California 94612 United States

Lead Scientists at UC Health

  • Otto Yang (ucla)
    Professor, Medicine. Authored (or co-authored) 156 research publications.
  • George Thompson (ucdavis)
    Associate Professor, Infectious Diseases, Medical Microbiology and Immunology. Authored (or co-authored) 133 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Karyopharm Therapeutics Inc
ID
NCT04349098
Phase
Phase 2
Study Type
Interventional
Last Updated