LITTLE ROCK, Ark. — Central Arkansas Veterans Healthcare System Researchers are participating in a VA-wide clinical trial for patients hospitalized with COVID-19.
Principal investigator Dr. Spyridoula Maraka and co-investigator Dr. Elena Ambrogini, both CAVHS endocrinologists and researchers, will conduct research supporting the VA’s clinical trial to test a Food and Drug Administration-approved prostate cancer drug as a potential treatment for male Veterans with COVID-19.
In a double-blind randomized controlled trial, VA scientists will compare the drug degarelix (trade name Firmagon) to a placebo for improving the clinical outcomes of nearly 200 Veterans who have been hospitalized with COVID-19.
CAVHS currently has one patient enrolled in the study that started October 6, and the plan is for 15 Veterans to receive the study drug.
Degarelix is often used to treat advanced cases of prostate cancer. It works by rapidly, but temporarily, suppressing the body’s production of male hormones. These hormones can fuel the growth of prostate cancer. Scientists are testing degarelix because lab evidence suggests male hormones trigger the production of a protein called TMPRSS2 on lung tissue. The virus that causes COVID-19 relies on TMPRSS2 to enter lung tissues.
“One injection can decrease the male hormones for about a month, which also decreases a protein called TMPRSS2,” said Maraka. “Surprisingly, the virus that causes COVID-19 uses this protein to get into the lung cells. So, we are thinking that this drug can shut down the production of TMPRSS2 in the lungs and stop the virus from getting in.
“By blocking the entry of the virus, we believe that this drug can decrease the severity of COVID-19 illness. It could help patients discharge from hospital faster, reduce the need for getting on a ventilator, and decrease their risk of dying from COVID-19,” she said.
By temporarily lowering male hormone levels, researchers believe they can reduce the production of TMPRSS2 in lung tissue and thus prevent the virus from penetrating lung cells. Hormone levels will return to normal at the end of treatment.
“For most infections, we have medicines that we can use to treat our patients. What is scary with this pandemic is that we don’t have very effective ways to deal with the virus causing COVID-19. This (degarelix) is a medication without any significant side effects and in theory it should work,” Maraka said.
The study will not involve female subjects, as existing evidence shows degarelix may have the opposite effect in the female body by increasing TMPRSS2 production, thus worsening the severity of COVID-19 symptoms.
The West Los Angeles VA Medical Center is leading the trial, which is funded by the VA. The study also involves 15 VA medical centers including those in New York (Brooklyn and Manhattan) and Washington state (Puget Sound), leveraging the Prostate Cancer Foundation/VA network of centers of excellence. The University of California, Los Angeles (UCLA) is involved in the analysis of research specimens, but not the clinical element of the study.
VA researchers expect to complete the trial in about four months.
For more information, visit www.research.va.gov.