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Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial.
Nickols, Nicholas G; Mi, Zhibao; DeMatt, Ellen; Biswas, Kousick; Clise, Christina E; Huggins, John T; Maraka, Spyridoula; Ambrogini, Elena; Mirsaeidi, Mehdi S; Levin, Ellis R; Becker, Daniel J; Makarov, Danil V; Adorno Febles, Victor; Belligund, Pooja M; Al-Ajam, Mohammad; Muthiah, Muthiah P; Montgomery, Robert B; Robinson, Kyle W; Wong, Yu-Ning; Bedimo, Roger J; Villareal, Reina C; Aguayo, Samuel M; Schoen, Martin W; Goetz, Matthew B; Graber, Christopher J; Bhattacharya, Debika; Soo Hoo, Guy; Orshansky, Greg; Norman, Leslie E; Tran, Samantha; Ghayouri, Leila; Tsai, Sonny; Geelhoed, Michelle; Rettig, Mathew B.
  • Nickols NG; Radiation Oncology Service, VA Greater Los Angeles Healthcare System, Los Angeles, California.
  • Mi Z; Department of Radiation Oncology, University of California, Los Angeles.
  • DeMatt E; Department of Urology, University of California, Los Angeles.
  • Biswas K; VA Cooperative Studies Program Coordinating Center, Perry Point, Maryland.
  • Clise CE; VA Cooperative Studies Program Coordinating Center, Perry Point, Maryland.
  • Huggins JT; VA Cooperative Studies Program Coordinating Center, Perry Point, Maryland.
  • Maraka S; VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico.
  • Ambrogini E; Pulmonary and Critical Care Medicine, Ralph H. Johnson VA Medical Center, Charleston, South Carolina.
  • Mirsaeidi MS; Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Medical University of South Carolina, Charleston.
  • Levin ER; Medicine Service, Central Arkansas Veterans Healthcare System, Little Rock.
  • Becker DJ; Division of Endocrinology and Metabolism, University of Arkansas for Medical Sciences, Little Rock.
  • Makarov DV; Medicine Service, Central Arkansas Veterans Healthcare System, Little Rock.
  • Adorno Febles V; Division of Endocrinology and Metabolism, University of Arkansas for Medical Sciences, Little Rock.
  • Belligund PM; Division of Pulmonary, Critical Care and Sleep, College of Medicine-Jacksonville, University of Florida, Jacksonville.
  • Al-Ajam M; Division of Endocrinology, Long Beach VA Medical Center, Long Beach, California.
  • Muthiah MP; Division of Endocrinology, Department of Medicine, University of California, Irvine.
  • Montgomery RB; Division of Hematology and Oncology VA New York Harbor Healthcare System, Manhattan Campus, New York.
  • Robinson KW; Perlmutter Cancer Center, NYU Langone Medical Center, New York, New York.
  • Wong YN; VA New York Harbor Healthcare System, Manhattan Campus, New York.
  • Bedimo RJ; NYU Grossman School of Medicine, New York, New York.
  • Villareal RC; VA New York Harbor Healthcare System, Manhattan Campus, New York.
  • Aguayo SM; NYU Grossman School of Medicine, New York, New York.
  • Schoen MW; VA New York Harbor Healthcare System, Brooklyn Campus, Brooklyn.
  • Goetz MB; VA New York Harbor Healthcare System, Brooklyn Campus, Brooklyn.
  • Graber CJ; Veterans Affairs Medical Center, Memphis, Tennessee.
  • Bhattacharya D; University of Tennessee Health Science Center, Memphis.
  • Soo Hoo G; Division of Hematology and Oncology, VA Puget Sound Health Care System, Seattle, Washington.
  • Orshansky G; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle.
  • Norman LE; Department of Hematology and Oncology, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.
  • Tran S; Division of Hematology-Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
  • Ghayouri L; Department of Hematology and Oncology, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.
  • Tsai S; Division of Hematology-Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
  • Geelhoed M; VA North Texas Health Care System, Dallas.
  • Rettig MB; UT Southwestern Medical Center, School of Medicine, Dallas, Texas.
JAMA Netw Open ; 5(4): e227852, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1798065
ABSTRACT
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, 2020, to April 8, 2021. Data were analyzed from August 9 to October 15, 2021.

Interventions:

Patients stratified by age, history of hypertension, and disease severity were centrally randomized 21 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

Measures:

The 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.

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 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 Relevance In 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 Registration ClinicalTrials.gov Identifier NCT04397718.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / COVID-19 Drug Treatment / Hypertension Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Aged / Humans / Male Country/Region as subject: North America Language: English Journal: JAMA Netw Open Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / COVID-19 Drug Treatment / Hypertension Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Aged / Humans / Male Country/Region as subject: North America Language: English Journal: JAMA Netw Open Year: 2022 Document Type: Article