Evaluation of Available Inventor 2020 Download TrialThe efficacy of proxalutamide on amelioration of COVID-19 severity in hospitalized patients has yet to be reported in detail. This randomized clinical trial tested the effect of testosterone suppression on outcomes among men hospitalized with COVID-19. Importantly, there were no significant differences in any clinical end points or AEs between degarelix and placebo groups. This study found that medical castration did not reduce the severity of COVID-19 among hospitalized men, and the phase 2 trial was stopped for futility. There was no dose adjustment to degarelix since it was a single, 1-time subcutaneous administration. Degarelix or placebo was administered within 60 minutes of reconstitution. Electrocardiogram was performed at the time of screening to exclude patients with corrected QT interval prolongation at baseline. Laboratory studies for the purposes of safety assessments were performed at the local VA laboratories and included routine complete blood counts, blood chemistry, liver function, cardiac function, and inflammatory laboratory tests. Total serum testosterone was checked at screening and, if still hospitalized, at days 8, 15, and 30. Adverse events were assessed daily during hospitalization, and after discharge, at days 30 and 60. Data for participants at each site were collected locally and entered into an electronic data capture system maintained and managed by the VA CSPCC. The HITCH randomized clinical trial was approved by the Department of Veterans Affairs Central Institutional Review Board and monitored by the VA Clinical Science Research and Development Data Monitoring Committee. Informed consents were obtained from all patients by study investigators or approved study personnel at each participating VA medical center. This report follows the Consolidated Standards of Reporting Trials reporting guideline. In this randomized clinical trial of androgen suppression vs placebo and usual care for men hospitalized with COVID-19, degarelix did not result in amelioration of COVID-19 severity. The composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization.
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