HITCH: A Multi-center VA Study for Male Veterans Hospitalized Due to COVID-19 Illness
Official Title: VAH using Degarelix in covid19 patients
Disease Type: Prostate Cancer - COVID-19
Conducting a multi-center VA study for male Veterans who are hospitalized due to COVID-19 illness. The study is a phase 2, randomized, placebo-controlled, double blind study that is assessing the effects of temporary androgen suppression on clinical outcomes including mortality, need for ongoing hospitalization and requirement for intubation. The rational for the study relates to an interesting convergence between prostate cancer research and COVID-19 research. As it turns out, the virus gains entry into the lung through a receptor called TMPRSS2. This receptor is very well known in prostate cancer research, because it plays a role in the development of prostate cancer in about half of the cases. Interestingly, the receptor is regulated by male hormones in prostate cancer, and it may also be regulated in lung tissue by male hormones. In the trial, the plan is to suppress male hormones temporarily to shut down the production of the receptor and thereby reduce the ability of the virus to gain entry into lung tissue.
The purpose of this study is to see if temporary androgen suppression can reduce the severity of COVID-19 illness. To suppress male hormone, the FDA-approved medication known as degarelix (Firmagon) will be used. Degarelix is approved for prostate cancer but not COVID-19. Degarelix is administered one time by an injection under the skin near the belly button.
Research Procedures (not a complete list):
Eligibility Criteria (not a complete list):
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