The Department of Veterans Affairs is set to launch clinical trials for male veterans with COVID-19, using a prostate cancer drug called degarelix (Firmagon).
Degarelix is an FDA-approved drug prescribed for the treatment of prostate cancer, which works by “rapidly but temporarily suppressing the body’s production of male hormones. These hormones can fuel the growth of prostate cancer,” according to VA.
The trial will be conducted on nearly 200 male veterans hospitalized with COVID-19. VA researchers will divide the participants into two groups – one group will receive degarelix, while the other a placebo.
VA Secretary Robert Wilkie said, “Veterans who have contracted this virus are in need of immediate care. This trial is an important step in advancing knowledge of a potential treatment for those infected with COVID-19. We are here to do everything in our power to preserve and protect life.”
The researchers are testing degarelix on COVID-19 patients “because lab evidence suggests male hormones trigger the production of a protein called TMPRSS2 on lung tissue” and the coronavirus relies on that protein to invade the lung tissue, according to VA.
Experts believe that by lowering male hormone levels, the drug could reduce the production of that protein in the lungs and prevent the virus from invading the lung cells. VA said, “Hormone levels will return to normal at the end of treatment.”
Some of the potential side effects of degarelix include hot flashes, increased weight, fatigue, hypertension, back or joint pains, chills, urinary tract infection, low sex drive, erectile dysfunction, and increase in some liver enzymes, per the FDA.
However, those side effects “are typically linked to long-term treatment,” VA said, adding that participants will only be given one dose if the drug that will last 28 days. “Any side effects of degarelix are thus expected to be temporary,” according to VA.
The department said the trial is not suitable for women veterans. The researchers said the drug could work antagonistically in women by increasing the production of the protein that helps the virus to enter the lung tissue, worsening COVID-19 symptoms.
The researchers expect the trial to complete in about four months.
The announcement of the degarelix clinical trial follows criticism of VA’s use of the antimalarial drug hydroxychloroquine to treat veterans who contracted the virus.
The department is also using remdesivir, an antiviral drug that has also been found effective at treating COVID-19.
VA had more than 11,800 coronavirus cases, including veterans, employees, and others treated under VA’s mission. Among those, over 8,800 are in recovery or it has been at least 14 days since they tested positive. As of Friday, VA recorded at least 985 deaths, including 683 inpatient deaths.