A COVID-19 patient at Norton Healthcare is the first in the world to participate in a randomized Phase 2 clinical study using low-dose selinexor. This oral drug, manufactured by Karyopharm Therapeutics Inc. and marketed as XPOVIO, is currently approved at higher doses by the U.S. Food and Drug Administration (FDA) as a treatment for cancer patients with relapsed or refractory multiple myeloma. This is just one therapy being studied at Norton Healthcare to help patients recover from COVID-19.
This clinical trial is studying the antiviral and anti-inflammatory properties of selinexor in patients with severe COVID-19. At Norton Healthcare, the study is being led by Don A. Stevens, M.D., a hematologist/oncologist with Norton Cancer Institute.
“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.”
Norton Healthcare is one of 40 locations internationally to participate in this clinical trial.
To be eligible, patients must be hospitalized with a laboratory-confirmed case of SARS-CoV-2 (the virus that causes COVID-19) and consent to participation within 48 hours of hospitalization.
Criteria to take part in selinexor COVID-19 trial
Patients must meet additional criteria:
- Confirmed laboratory diagnosis of SARS-CoV2 by standard approved Reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent approved testing.
- Currently hospitalized and consented within the first 48 hours of hospitalization.
- Informed consent provided as above (participants must be 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, Oxygen saturation (SaO2) < 93% on room air or requires > 2 Liter (L)/minute 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.
- 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
More on the selinexor COVID-19 study
Selinexor is an oral selective inhibitor of nuclear export (SINE) compound that blocks the cellular protein XPO1, which may be involved in both the replication of SARS-CoV-2 and in the inflammatory response to the virus.
The randomized, multicenter, placebo-controlled Phase 2 study (XPORT-CoV-1001/NCT04349098) of low-dose selinexor is designed to assess the activity and safety of 20 milligrams of selinexor given orally three times a week for two weeks. Patients tolerating therapy well and experiencing clinical benefit may be eligible to continue treatment for an additional two weeks at the discretion of the treating physician.
Norton Healthcare’s clinical trials program is the most robust program in the region and has been instrumental in the development of many drugs and medical devices. Norton Healthcare clinical trials include emerging treatments for cancer, cardiovascular issues, neurological conditions, orthopedic conditions, maternal-fetal medicine and many more.