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0 0.5 1 1.5 2+ Mortality 18% Improvement Relative Risk Ventilation -19% Ongoing hospitalization.. -17% primary Hospitalization time -20% Degarelix  HITCH  LATE TREATMENT  DB RCT Is late treatment with antiandrogens beneficial for COVID-19? Double-blind RCT 96 patients in the USA (July 2020 - April 2021) Trial underpowered for serious outcomes Nickols et al., JAMA Network Open, Apr 2022 Favors degarelix Favors control

Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19

Nickols et al., JAMA Network Open, doi:10.1001/jamanetworkopen.2022.7852, HITCH, NCT04397718
Apr 2022  
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5th treatment shown to reduce risk in August 2020
*, now known with p = 0.000000056 from 49 studies.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,000+ studies for 60+ treatments.
Early terminated RCT with 62 very late stage (79% on oxygen) degarelix patients and 34 placebo patients, showing no significant differences with treatment.
For discussion of many issues with this study see
risk of death, 18.3% lower, RR 0.82, p = 0.66, treatment 11 of 62 (17.7%), control 7 of 34 (20.6%), NNT 35, adjusted per study, odds ratio converted to relative risk, multivariable.
risk of mechanical ventilation, 18.8% higher, RR 1.19, p = 0.70, treatment 13 of 62 (21.0%), control 6 of 34 (17.6%).
risk of ongoing hospitalization, mortality, or mechanical ventilation, 16.7% higher, RR 1.17, p = 0.70, treatment 15 of 62 (24.2%), control 7 of 34 (20.6%), adjusted per study, odds ratio converted to relative risk, multivariable, primary outcome.
hospitalization time, 20.0% higher, relative time 1.20, p = 0.94, treatment 62, control 34.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Nickols et al., 19 Apr 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 34 authors, study period 22 July, 2020 - 8 April, 2021, trial NCT04397718 (history) (HITCH).
This PaperAntiandrogensAll
Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19
MD Nicholas G Nickols, PhD Zhibao Mi, PhD Ellen Dematt, Kousick Biswas, PharmD; Christina E Clise, MD John T Huggins, MD Spyridoula Maraka, MD Elena Ambrogini, PhD Mehdi S Mirsaeidi, MD, MPH Ellis R Levin, MD Daniel J Becker, MD, MPH Danil V Makarov, Victor Adorno Febles, MD Pooja M Belligund, MD Mohammad Al-Ajam, MD Muthiah P Muthiah, MD Robert B Montgomery, MD Kyle W Robinson, MD; Yu-Ning Wong, MSCE Roger J Bedimo, MD Reina C Villareal, MD; Samuel M Aguayo, MD Martin W Schoen, MD, MPH Matthew B Goetz, MD Christopher J Graber, MD Debika Bhattacharya, Guy Soo Hoo, MD Greg Orshansky, MSW Leslie E Norman, BS Samantha Tran, BA Leila Ghayouri, AA Sonny Tsai, MPAS Michelle Geelhoed, MD Mathew B Rettig
JAMA Network Open, doi:10.1001/jamanetworkopen.2022.7852
IMPORTANCE SARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen therapies reduce expression of TMPRSS2. OBJECTIVE To determine if temporary androgen suppression induced by degarelix improves clinical outcomes of inpatients hospitalized with COVID-19. DESIGN, SETTING, AND PARTICIPANTS The Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH) phase 2, placebo-controlled, double-blind, randomized clinical trial compared efficacy of degarelix plus standard care vs placebo plus standard care on clinical outcomes in men hospitalized with COVID-19 but not requiring invasive mechanical ventilation. Inpatients were enrolled at 14 Department of Veterans Affairs hospitals from July 22,
Conflict of Interest Disclosures: Dr Nickols reported receiving grants from Lantheus, Bayer, and Janssen and personal fees from Oncolinea outside the submitted work. Dr Wong reported receiving grants from the Prostate Cancer Foundation during the conduct of the study. Dr Bedimo reported receiving grants from Merck and ViiV Healthcare and personal fees from Merck, ViiV Healthcare, Janssen, Gilead Sciences, and Theratechnologies outside the submitted work. Dr Rettig reported receiving grants from Johnson & Johnson, Bayer, and Pfizer and
Acquisition, Nickols, Mi, Dematt, Clise et al., Critical revision of the manuscript for important intellectual content
Administrative, Nickols, Mi, Biswas, Clise et al., Supervision: Nickols
Cadegiani, Mccoy, Wambier, Proxalutamide significantly accelerates viral clearance and reduces time to clinical remission in patients with mild to moderate COVID-19: results from a randomized, doubleblinded, placebo-controlled trial, Cureus, doi:10.7759/cureus.13492
Caffo, Zagonel, Baldessari, On the relationship between androgen-deprivation therapy for prostate cancer and risk of infection by SARS-CoV-2, Ann Oncol, doi:10.1016/j.annonc.2020.06.005
Cochran, Affairs Medical Center
Contributions, Nickols, Mi, Biswas, Clise et al., Drs Rettig and Nickols had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis
Davey, Grossmann, Androgen receptor structure, function and biology: from bench to bedside, Clin Biochem Rev
Deng, Rasool, Russell, Natesan, Asangani, Targeting androgen regulation of TMPRSS2 and ACE2 as a therapeutic strategy to combat COVID-19, iScience, doi:10.1016/j.isci.2021.102254
Hoffmann, Kleine-Weber, Schroeder, SARS-CoV-2 cell entry depends on ACE2 and TMPRSS2 and is blocked by a clinically proven protease inhibitor, Cell, doi:10.1016/j.cell.2020.02.052
Klein, Li, Milinovich, Androgen deprivation therapy in men with prostate cancer does not affect risk of infection with SARS-CoV-2, J Urol, doi:10.1097/JU.0000000000001338
Klotz, Boccon-Gibod, Shore, The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer, BJU Int, doi:10.1111/j.1464-410X.2008.08183.x
Mccoy, Goren, Cadegiani, Proxalutamide reduces the rate of hospitalization for covid-19 male outpatients: a randomized double-blinded placebo-controlled trial, Front Med, doi:10.3389/fmed.2021.668698
Michael, Debakey, Va, None
Montopoli, Zumerle, Vettor, Androgen-deprivation therapies for prostate cancer and risk of infection by SARS-CoV-2: a population-based study (N = 4532), Ann Oncol, doi:10.1016/j.annonc.2020.04.479
Nickols, Goetz, Graber, 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, doi:10.1186/s13063-021-05389-0
O'brien, Fleming, A multiple testing procedure for clinical trials, Biometrics, doi:10.2307/2530245
Patel, Zhong, Liaw, Does androgen deprivation therapy protect against severe complications from COVID-19?, Ann Oncol, doi:10.1016/j.annonc.2020.06.023
Qiao, Wang, Mannan, Targeting transcriptional regulation of SARS-CoV-2 entry factors ACE2 and TMPRSS2, Proc Natl Acad Sci, doi:10.1073/pnas.2021450118
Rick, Block, Schally, An update on the use of degarelix in the treatment of advanced hormonedependent prostate cancer, Onco Targets Ther, doi:10.2147/OTT.S32426
Schmidt, Tucker, Bakouny, Association between androgen deprivation therapy and mortality among patients with prostate cancer and COVID-19, JAMA Netw Open, doi:
Welén, Rosendal, Gisslén, A phase 2 trial of the effect of antiandrogen therapy on COVID-19 outcome: no evidence of benefit, supported by epidemiology and in vitro data, Eur Urol, doi:10.1016/j.eururo.2021.12.013
Late treatment
is less effective
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