Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19
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.
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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%).
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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.
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hospitalization time, 20.0% higher, relative time 1.20, p = 0.94, treatment 62, control 34.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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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).
Abstract: Original Investigation | Infectious Diseases
Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men
With COVID-19
The HITCH Randomized Clinical Trial
Nicholas G. Nickols, MD, PhD; Zhibao Mi, PhD; Ellen DeMatt, MA; Kousick Biswas, PhD; Christina E. Clise, PharmD; John T. Huggins, MD; Spyridoula Maraka, MD;
Elena Ambrogini, MD, PhD; Mehdi S. Mirsaeidi, MD, MPH; Ellis R. Levin, MD; Daniel J. Becker, MD, MPH; Danil V. Makarov, MD; 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, MD, 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, MD; Guy Soo Hoo, MD; Greg Orshansky, MD; Leslie E. Norman, MSW; Samantha Tran, BS; Leila Ghayouri, BA; Sonny Tsai, AA;
Michelle Geelhoed, MPAS; Mathew B. Rettig, MD
Abstract
Key Points
IMPORTANCE SARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen
therapies reduce expression of TMPRSS2.
Question Does androgen suppression
improve clinical outcomes in
hospitalized men with COVID-19?
OBJECTIVE To determine if temporary androgen suppression induced by degarelix improves clinical
Findings In this randomized clinical trial
outcomes of inpatients hospitalized with COVID-19.
including 96 men, androgen
suppression with the addition of
DESIGN, SETTING, AND PARTICIPANTS The Hormonal Intervention for the Treatment in Veterans
degarelix vs placebo plus standard care
With COVID-19 Requiring Hospitalization (HITCH) phase 2, placebo-controlled, double-blind,
did not show reduction of the composite
randomized clinical trial compared efficacy of degarelix plus standard care vs placebo plus standard
end point of mortality, ongoing
care on clinical outcomes in men hospitalized with COVID-19 but not requiring invasive mechanical
hospitalization, or requirement for
ventilation. Inpatients were enrolled at 14 Department of Veterans Affairs hospitals from July 22,
mechanical ventilation at day 15 after
2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021.
randomization.
Meaning This randomized clinical trial
INTERVENTIONS Patients stratified by age, history of hypertension, and disease severity were
centrally randomized 2:1 to degarelix, (1-time subcutaneous dose of 240 mg) or a saline placebo.
Standard care included but was not limited to supplemental oxygen, antibiotics, vasopressor
found that androgen suppression did
not improve outcomes in men
hospitalized for COVID-19.
support, peritoneal dialysis or hemodialysis, intravenous fluids, remdesivir, convalescent plasma, and
dexamethasone.
MAIN OUTCOMES AND MEASURES The composite primary end point was mortality, ongoing need
for hospitalization, or requirement for mechanical ventilation at day 15 after randomization.
+ Visual Abstract
+ Supplemental content
Author affiliations and article information are
listed at the end of this article.
Secondary end points were time to clinical improvement, inpatient mortality, length of
hospitalization, duration of mechanical ventilation, time to achieve a temperature within reference
range, maximum severity of COVID-19, and the composite end point at 30 days.
RESULTS The trial was stopped for futility after the planned interim analysis, at which time there
were 96 evaluable patients, including 62 patients randomized to the degarelix..
Late treatment
is less effective
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