The U.S. Department of Veterans Affairs launched a clinical trial to investigate the efficacy of an U.S. Food and Drug Administration (FDA)—approved prostate cancer drug for male veterans infected with SARS-CoV-2, the virus behind the COVID-19 pandemic. Investigators will compare Ferring Pharmaceuticals’ degarelix (Firmagon®) to a placebo for improving clinical outcomes of nearly 200 veterans who have been hospitalized with SARS-CoV-2.
Veterans of America Hit Hard
The COVID-19 pandemic has hit United States Veterans hard as at least 985 of those who have served the country have died due to SARS-CoV-2. More than 11,800 COVID-19 cases, including veterans, employees and others, have been treated under the VA’s fourth mission. Of those, 8,800 are considered “convalescent” or that they are now in recovery or at least 14 days since a positive test. According to ConnectingVets, total VA deaths increased by 19% over the last week, although total active cases declined by 25% over the same period. Of the 43,000 COVID-19 tests the VA has administered nationwide, approximately 8% have come back positive; of those 8% testing positive, a total of 8% of that group has died.
Testosterone is a male hormone that promotes growth of many prostate tumors and therefore reducing circulating testosterone to very low levels is often the treatment goal in the management of advanced prostate cancer. Degarelix, made by Ferring Pharmaceuticals, has an immediate onset of action, binding to gonadotropin-releasing hormone (GnRH) receptors in the pituitary gland and blocking their interaction with GnRH. This induces a fast and profound reduction in lutenizing hormone (LH), follicle-stimulating hormone (FSH) and in turn, testosterone suppression.
Hence, Degarelix is known as a drug to treat advanced cases of prostate cancer, according to the VA the drug “rapidly but temporarily suppresses the body’s production of male hormones. These hormones can fuel the growth of prostate cancer.” According to the VA, “because lab evidence suggests male hormones trigger the production of a protein called TMPRSS2 on lung tissue” and as SARS-CoV-2 virus depends on this protein for entry into lung tissue.
Possible side effects can include hot flashes, skin flush, weight gain and fatigue as well as a number of other issues. See the FDA label. However, the VA articulates that typical side effect reporting is tied to long-term usage.
Now the Department of Veterans Affairs has launched a clinical trial for veterans infected with COVID-19 using degarelix (trade name Firmagon). The double-blind, randomized controlled trial will include almost 200 male veterans hospitalized with COVID-19, reports Abbie Bennett with ConnectingVets.
As part of the study, the VA reports that patients will receive one dose for a period of 28 days. Hence, the VA reports, “Any side effects of degarelix are thus expected to be temporary.” And the study isn’t open for women as studies reveal the drug can increase the production of protein in females.
The study will be led by the West Los Angeles VA Medical Center; VA medical centers in New York (Brooklyn and Manhattan) as well as Washington (Puget Sound) will participate in the study which will last for approximately four months. The research sites will leverage the Prostate Cancer Foundation/VA network centers of excellence. Additionally, University of California, Los Angeles will participate by analyzing the research specimens.