A Study to Test the Activity and Safety of Experimental Selinexor (KPT-330) for Severe COVID-19 (Coronavirus) Infection

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Study coordinator
Name - Katelyn Trigg
Email - ktrigg@ucdavis.edu
Phone - (916) 734-8033

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years and older
Gender:
Any
Healthy Volunteers: No
Keywords: COVID-19, coronavirus
Type: Drug Study
Target:
20 Participants
Investigator:
Description
Coronavirus disease 2019 (COVID-19) is caused by the single stranded RNA virus (SARS-CoV2). It may also cause an inflammatory response.

This inflammation is harmful to your health.
It can lead to:
- multiorgan dysfunction (altered function of various organ systems such as heart, lung, and kidney),
- respiratory failure and
- even death.

A protein called exportin 1 (XPO1) has been shown to be important in both the virus lifecycle and the inflammation caused by the virus.

Inhibition of XPO1 by selinexor could lead to both anti-viral and anti-inflammatory activity.

Selinexor is approved by the FDA for the use in certain patients with a type of cancer called multiple myeloma. It is considered experimental for use in COVID-19. Experimental means that it has not been approved by the FDA for the treatment of COVID-19.
This study requires

If you agree to participate in the study, you will be given the standard of care treatment for Covid-19 plus either selinexor or placebo.

The purpose of this research study is to see if selinexor:

  • speeds up your recovery,
  • decreases your viral load (amount of virus in your body),
  • shortens your hospitalization and
  • reduces morbidity and mortality (complications or chance of dying) compared to standard of care treatment.

You may be assigned to receive a placebo if you participate in this study. A placebo is a substance that has no active ingredients. The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given each treatment. This is a blinded study which means that neither you nor your doctor will know if you are receiving selinexor or placebo.

Who can participate

Patients are eligible to be included in the study only if they meet all the following criteria:

  • Age ≥18 years
  • Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved RT-PCR assay or equivalent FDA-approved testing (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 severe COVID-19 as demonstrated by: a. At least 1 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 b. Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: respiratory rate ≥30 breaths/min, heart rate ≥125/min, SaO2 <93% on room air or requires >2L oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2 <300 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 patient to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the patient’s chart and entered in the electronic case report form.
  • Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

Exclusion Criteria:

  • Evidence of critical COVID-19 based on: a. 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) b. Septic shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg) c. 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: a. Patients with severe neutropenia (ANC <1000 x 109 /L) or b. Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)
  • Inadequate renal and liver function as indicated by the following labs: a. Creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault. b. Aspartate transaminase (AST) or alanine transaminase (ALT) >2.5 x upper limit of normal (ULN) c. Total bilirubin >1.5 x upper limit of normal (ULN)
  • Hyponatremia defined as sodium less than 135 mEq/L
  • Unable to take oral medication when inform consent is obtained.
  • Patients with a legal guardian or who are incarcerated.
  • Patients taking strong CYP3A inhibitors or inducers.
  • Pregnant and breastfeeding women
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will receive 1 tablet of 20 mg selinexor orally three times a week every other day for 2 weeks. If your study doctor believes that you are gaining clinical benefit, dosing may continue every other day for an additional 2 weeks. If you are discharged from the hospital without supplemental oxygen, you may continue treatment for the total duration of 28 days.
Recruitment period
From April 20, 2020
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Katelyn Trigg
Research Topic
Conditions:
  • COVID-19
  • coronavirus

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