LOUISVILLE, Ky. (WDRB) -- Norton Healthcare is taking part in a clinical trial using a cancer treatment drug for patients with serious cases of COVID-19.
There are 40 sites in the U.S. and Europe that will be participating in this study. Norton was the first to activate its trial with the first patient in the world this week.
The oral drug, Selinexor, is manufactured by Karyopharm Therapeutics Inc., and it has already been approved by the U.S. Food and Drug Administration for cancer treatment.
“This is a drug that we helped develop in the cancer world and looking at this as a treatment for a blood cancer,” said Dr. Don Stevens, principal investigator and oncologist with Norton Cancer Institute. “And that’s why we were approached to do this trial with this drug for COVID-19 patients.”
Stevens is leading this clinical study along with Dr. Becky Champion, a clinical pharmacy specialist at Norton Cancer Institute. Champion said Selinexor is specifically used at a high-dose for a certain type of blood cancer known as multiple myeloma.
Now, they are studying the drug at a low dose to see how effective it might be at decreasing the coronavirus’ ability to reproduce in patients’ cells.
“Selinexor is also thought to block certain inflammatory proteins, which could decrease the pulmonary inflammation that we see in COVID patients,” Champion said.
The inflammation in some severe COVID-19 patients has caused organ damage.
The drug has proven fairly successful in lab and animal studies, so Stevens in hopeful it will be successful for patients, too. He said he admires the first volunteer Norton patient for being willing to advance science and wanting help others in the process.
“We’re very excited for this potential therapy for our patients,” he said. “It really is important that we do these clinical trials so that we’re not just throwing everything at this disease. We want to do things in a very scientific, logical way.”
The patients participating in this study must meet certain eligibility criteria. Their cases must be serious enough to be hospitalized, and they must volunteer.
Some patients will be taking the drug Selinexor, while others will be taking a placebo. Patients will take a low-dose three times a week for two weeks. If they are doing well, then they can continue treatment for another two weeks.
Stevens said they will be monitoring patients’ blood tests closely to measure improvements. They will also be taking note of how quickly patients improve, if oxygen is no longer needed and if there are any side effects.
“We don’t know that it works for a fact. That’s the point of this clinical trial,” Stevens said. “But the science behind it is very, very good.”
Typically, clinical studies take around four months to plan and coordinate before launching. Since Norton already participated in Phase 1, by studying this drug for cancer treatment, it took only a few weeks to start Phase 2 for COVID-19 patients.
Norton Healthcare is not being paid to participate in this trial, but it is being reimbursed for the cost of executing the study.
A press release from Norton Healthcare lists the following eligibility 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
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