In a double-blind, randomized controlled trial, VA scientists will compare the drug degarelix (trade name Firmagon) to a placebo to improve clinical outcomes for nearly 200 veterans hospitalized with COVID-19.
"Veterans who have contracted this virus need immediate care," said Robert Wilkie, Secretary of State for VA. "This trial is an important step in advancing knowledge about a potential treatment for those infected with COVID-19. We are here to do everything we can to preserve and protect life.
Degarelix is often used to treat advanced 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 laboratory results suggest that male hormones trigger the production of a protein called TMPRSS2 in lung tissue. The virus that causes COVID-19 relies on TMPRSS2 to enter lung tissue.
Researchers at the University of Alabama at Birmingham and Columbia University have applied advanced artificial intelligence and computational genomics techniques and used this laboratory evidence for these COVID-19 data. The researchers collaborated with VA to plan the new trial.
The potential side effects of degarelix are usually related to long-term treatment. In the trial, patients will receive a single dose of the drug for 28 days. Any side effects from the drug should therefore be temporary.
By temporarily lowering male hormone levels, the researchers believe they can reduce the production of TMPRSS2 in lung tissue and thereby prevent the virus from entering lung cells. Hormone levels will return to normal at the end of treatment.
The study is not suitable for female veterans. Existing evidence shows that degairing can have the opposite effect on the female body by increasing the production of TMPRSS2, thereby worsening the severity of VID19 symptoms.
The West Los Angeles Veterans Medical Center is leading the trial. The study also involves medical centers in New York (Brooklyn and Manhattan) and Washington State (Puget Sound), using the Prostate Cancer Foundation/VA Network of Centers of Excellence. The University of California, Los Angeles (UCLA) is involved in the analysis of the research samples, but not in the clinical component of the study.
VA researchers expect to complete the trial in about four months.