Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization

Summary

The purpose of this study is to determine if temporary androgen suppression improves the clinical outcomes of Veterans who are hospitalized to an acute care ward due to COVID-19.

Timeline

Start

2020-07-06

Primary completion

2021-06-08

Completion

2021-06-08

Outcome

Missed primary endpoint

paper For the primary end point, there was no significant difference between the degarelix and placebo groups (19 patients [30.6%] vs 9 patients [26.5%]; P = .67). PMID 35438754 ↗

Publications

• Results Nickols NG, Mi Z, DeMatt E, Biswas K, Clise CE, Huggins JT, Maraka S, Ambrogini E, Mirsaeidi MS, Levin ER, Becker DJ, Makarov DV, Adorno Febles V, Belligund PM, Al-Ajam M, Muthiah MP, Montgomery RB, Robinson KW, Wong YN, Bedimo RJ, Villareal RC, Aguayo SM, Schoen MW, Goetz MB, Graber CJ, Bhattacharya D, Soo Hoo G, Orshansky G, Norman LE, Tran S, Ghayouri L, Tsai S, Geelhoed M, Rettig MB. Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e227852. doi: 10.1001/jamanetworkopen.2022.7852.
• Nickols NG, Goetz MB, Graber CJ, Bhattacharya D, Soo Hoo G, Might M, Goldstein DB, Wang X, Ramoni R, Myrie K, Tran S, Ghayouri L, Tsai S, Geelhoed M, Makarov D, Becker DJ, Tsay JC, Diamond M, George A, Al-Ajam M, Belligund P, Montgomery RB, Mostaghel EA, Sulpizio C, Mi Z, Dematt E, Tadalan J, Norman LE, Briones D, Clise CE, Taylor ZW, Huminik JR, Biswas K, Rettig MB. Hormonal intervention for the treatment of veterans with COVID-19 requiring hospitalization (HITCH): a multicenter, phase 2 randomized controlled trial of best supportive care vs best supportive care plus degarelix: study protocol for a randomized controlled trial. Trials. 2021 Jul 5;22(1):431. doi: 10.1186/s13063-021-05389-0.

Drugs

Indications