Androgen suppression therapy with degarelix had no effect on clinical outcomes among older men hospitalized with COVID-19 infection, according to results of a phase 2, placebo-controlled, double-blinded, randomized clinical trial published in JAMA Network Open.
Between July 2020 and April 2021, investigators enrolled adult men hospitalized for COVID-19 infection who did not require invasive mechanical ventilation (IMV). They randomly assigned patients in a 2:1 fashion to receive either standard treatment plus AR suppression therapy with degarelix or placebo. Degarelix was administered once subcutaneously at a dose of 240 mg within 24 hours of treatment allocation. All patients were stratified by age, hypertension history, and disease severity score. The primary endpoints were all-cause mortality, ongoing need for hospitalization, and need for IMV by day 15 after treatment allocation.
Among 96 patients included in the final analysis, 62 were in the degarelix group vs 34 in the placebo group. The median patient age was 70.5 (range, 48-85) years, 39.6% were Black, the most common comorbidity was hypertension in 78.1%, and the mean testosterone concentration at baseline was 159.5 ng/dL.
In regard to the primary endpoints, there were no statistically significant differences between the 2 groups (adjusted odds ratio [aOR], 1.19; 95% CI, 0.46-3.06; P =.67). There also were no significant differences in secondary outcomes (aOR, 1.22 95% CI, 0.44-3.42; P =.69). The occurrence of all-cause mortality prior to hospital discharge was similar between patients in the degarelix vs placebo groups (17.7% vs 17.6%; aOR, 0.95; 95% CI, 0.31-2.92; P =.99), as well as the median length of hospitalization (P =.84). For patients in the degarelix and placebo groups, the mean testosterone concentration among those hospitalized at day 8 was 40.4 vs 119.6 ng/dL, respectively.
Further analysis was conducted to compare the occurrence of adverse events between the 2 groups. Among patients who received degarelix vs those who received placebo, no significant differences were noted for the rate of adverse events overall (21.0% vs 23.5%) or for the rate of severe events (30.6% vs 32.4%).
This study was limited by the use of different standards of care for the treatment of COVID-19 infection.
“The timing of androgen suppression after the diagnosis and subsequent hospitalization for COVID-19 may be too late to affect the outcomes of patients,” the investigators noted. They concluded “it is possible that earlier use of androgen-directed therapies during the initial infection and viral replication may be a more effective strategy.”
Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Nickols NG, Mi Z, DeMatt E, et al. Effect of androgen suppression on clinical outcomes in hospitalized men with COVID-19: The HITCH randomized clinical trial. JAMA Netw Open. Published online April 19, 2022. doi:10.1001/jamanetworkopen.2022.7852