Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial.

Nickols NG, Mi Z, DeMatt E, Biswas K, Clise CE, Huggins JT, Maraka S, Ambrogini E, Mirsaeidi MS, Levin ER, Becker DJ, Makarov DV and 22 more

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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

JAMA network open1 Apr 2022Cited by 21 (Europe PMC)

PMID35438754PMCIDPMC9020208DOI10.1001/jamanetworkopen.2022.7852PepBankPUB-35438754

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Summary

ImportanceSARS-CoV-2 entry requires the TMPRSS2 cell surface protease. Antiandrogen therapies reduce expression of TMPRSS2.ObjectiveTo determine if temporary androgen suppression induced by degarelix improves clinical outcomes of inpatients hospitalized with COVID-19.Design, setting, and participantsThe 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, 2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021.InterventionsPatients 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 support, peritoneal dialysis or hemodialysis, intravenous fluids, remdesivir, convalescent plasma, and dexamethasone.Main outcomes and measuresThe composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization. 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.ResultsThe 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 group and 34 patients in the placebo group, out of 198 initially planned. The median (range) age was 70.5 (48-85) years. Common comorbidities included chronic obstructive pulmonary disorder (15 patients [15.6%]), hypertension (75 patients [78.1%]), cardiovascular disease (27 patients [28.1%]), asthma (12 patients [12.5%]), diabetes (49 patients [51.0%]), and chronic respiratory failure requiring supplemental oxygen at baseline prior to COVID-19 (9 patients [9.4%]). 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). Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]). There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns.Conclusions and relevanceIn 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.Trial registrationClinicalTrials.gov Identifier: NCT04397718.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In hospitalized men with COVID-19, the primary composite occurred in 19 degarelix patients (30.6%) versus 9 placebo patients (26.5%), without a significant difference (P = .67).
In plain wordsIn hospitalized men with COVID-19, the primary composite outcome did not differ significantly between degarelix and placebo.
Peptide
Degarelix
Outcome
No significant changeComposite endpoint at day 15
Study
n = 96
Comparator
Saline placebo plus standard care
Analysis
Primary
Outcome group
COVID-19 Clinical Outcomes · Infection
Studied dose
240 mg once · subcutaneousAs given in this study (human).
Measurements
Primary composite end point at day 15
30.6%
Degarelix group, 19 patients
Primary composite end point at day 15
26.5%
Placebo group, 9 patients
Source sentences
Summary
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).
3 context sentences(design, population, supporting numbers)
Summary · context
The composite primary end point was mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at day 15 after randomization.
Summary · context
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.
Summary · context
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.
Show in the study text Report a problemFND-3543875401
02HumanRandomized controlled trialEfficacy outcome
In hospitalized men with COVID-19, no secondary clinical endpoint differed between degarelix and placebo.
In plain wordsIn hospitalized men with COVID-19, secondary clinical outcomes did not differ between degarelix and placebo.
Peptide
Degarelix
Outcome
No significant changeSecondary clinical endpoints
Study
n = 96
Comparator
Saline placebo plus standard care
Analysis
Secondary
Outcome group
COVID-19 Clinical Outcomes · Infection
Studied dose
240 mg once · subcutaneousAs given in this study (human).
Source sentences
Summary
Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]).
3 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
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.
Summary · context
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.
Show in the study text Report a problemFND-3543875402
03HumanRandomized controlled trialSafety outcome
In hospitalized men with COVID-19, inpatient mortality was 11 patients (17.7%) with degarelix versus 6 (17.6%) with placebo, without a reported difference.
In plain wordsIn hospitalized men with COVID-19, inpatient mortality did not differ between degarelix and placebo.
Peptide
Degarelix
Outcome
No significant changeInpatient mortality
Study
n = 96
Comparator
Saline placebo plus standard care
Analysis
Secondary
Outcome group
Mortality · Infection
Studied dose
240 mg once · subcutaneousAs given in this study (human).
Measurements
Inpatient mortality
17.7%
Degarelix group, 11 patients
Inpatient mortality
17.6%
Placebo group, 6 patients
Source sentences
Summary
Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]).
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
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.
Show in the study text Report a problemFND-3543875403
04HumanRandomized controlled trialSafety outcome
In hospitalized men with COVID-19, all-cause mortality was 11 patients (17.7%) with degarelix versus 7 (20.6%) with placebo, without a reported difference.
In plain wordsIn hospitalized men with COVID-19, all-cause mortality did not differ between degarelix and placebo.
Peptide
Degarelix
Outcome
No significant changeAll-cause mortality
Study
n = 96
Comparator
Saline placebo plus standard care
Outcome group
Mortality · Infection
Studied dose
240 mg once · subcutaneousAs given in this study (human).
Measurements
All-cause mortality
17.7%
Degarelix group, 11 patients
All-cause mortality
20.6%
Placebo group, 7 patients
Source sentences
Summary
Similarly, no differences were observed between degarelix and placebo groups in any secondary end points, including inpatient mortality (11 patients [17.7%] vs 6 patients [17.6%]) or all-cause mortality (11 patients [17.7%] vs 7 patents [20.6%]).
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
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.
Show in the study text Report a problemFND-3543875404
05HumanRandomized controlled trialSafety outcome
In hospitalized men with COVID-19, adverse events occurred in 13 degarelix patients (21.0%) versus 8 placebo patients (23.5%), without a reported difference.
In plain wordsIn hospitalized men with COVID-19, adverse event rates did not differ between degarelix and placebo.
Peptide
Degarelix
Outcome
No significant changeAdverse events
Study
n = 96
Comparator
Saline placebo plus standard care
Outcome group
Adverse events · Whole body
Studied dose
240 mg once · subcutaneousAs given in this study (human).
Measurements
Adverse events
21%
Degarelix group, 13 patients
Adverse events
23.5%
Placebo group, 8 patients
Source sentences
Summary
There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns.
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
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.
Show in the study text Report a problemFND-3543875405
06HumanRandomized controlled trialSafety outcome
In hospitalized men with COVID-19, serious adverse events occurred in 19 degarelix patients (30.6%) versus 13 placebo patients (32.4%), without a reported difference.
In plain wordsIn hospitalized men with COVID-19, serious adverse event rates did not differ between degarelix and placebo.
Peptide
Degarelix
Outcome
No significant changeSerious adverse events
Study
n = 96
Comparator
Saline placebo plus standard care
Outcome group
Adverse events · Whole body
Studied dose
240 mg once · subcutaneousAs given in this study (human).
Measurements
Serious adverse events
19 patients
degarelix; 30.6%
Serious adverse events
13 patients
placebo; 32.4%
Source sentences
Summary
There were no differences between degarelix and placebo groups in the overall rates of adverse events (13 patients [21.0%] vs 8 patients [23.5%) and serious adverse events (19 patients [30.6%] vs 13 patients [32.4%]), nor unexpected safety concerns.
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
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.
Show in the study text Report a problemFND-3543875406

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT04397718

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

VA Office of Research and Developmentn = 966 Jul 2020 to 8 Jun 2021

COVID-19

Trial page ClinicalTrials.govUpdated 6 Jun 2022

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

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