Kentucky Enrolls First Patient in the World for COVID-19 Drug Trial

LOUISVILLE, Ky. – A positive coronavirus patient at Norton Healthcare is the first person in the world to participate in Phase 2 clinical study using a new oral drug.

The drug, selinexor, is being marketed as XPOVIO and is already approved by the U.S. Food and Drug Administration (FDA) in higher doses to treat cancer patients. The coronavirus trial will use a low-dose version of the drug.

The clinical trial is looking at the antiviral and anti-inflammatory properties of selinexor in patients with severe COVID-19. Doctor Don Stevens, a hematologist/oncologist with Norton Cancer Institute is leading the study. 

“We are examining how we can decrease the ability of the virus to replicate or reproduce in our patients’ cells,” Dr. Stevens said. “We also want to see how it can decrease the release of a biochemical responsible for inflammation that in some cases can cause organ damage.”

Louisville’s Norton Healthcare is one of 40 locations internationally to participate in this clinical trial.

To participate in the study, patients must meet several criteria including: 

  • Confirmed laboratory diagnosis of SARS-CoV2 — the virus that causes COVID-19 — by standard approved Reverse transcription polymerase chain (RT-PCR) assay or equivalent approved testing.
  • Currently hospitalized and consented within the first 48 hours of hospitalization.
  • 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.

There are more criteria and if interested you can read the full list of eligibility criteria.

The study is looking at the safety and effectiveness of 20 milligrams of selinexor given orally three times a week for two weeks. Patients who do well on the therapy could be eligible to continue treatment for another two weeks at the discretion of the doctor treating them.