Evidence map›Paper›PMID 34225789›Full record

ArticleTrials2021

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.

Nicholas G Nickols, Matthew B Goetz, Christopher J Graber, Debika Bhattacharya, Guy Soo Hoo, Matthew Might, David B Goldstein, Xinchen Wang, Rachel Ramoni, Kenute Myrie and 24 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04397718 (Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04397718 phase2completednot on this map

Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH): A Multicenter, Phase 2 Randomized Controlled Trial of Best Supportive Care (BSC) vs BSC Plus Degarelix

TypeinterventionalSponsorVA Office of Research and DevelopmentRan2020 to 2021Enrolled96ConditionsCOVID-19ArmsDegarelix, Saline
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors at 10 institutions in 1 country.

Nicholas G NickolsRadiation Oncology Service, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Matthew B GoetzInfectious Diseases Section, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Christopher J GraberInfectious Diseases Section, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Debika BhattacharyaInfectious Diseases Section, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Guy Soo HooDivision of Pulmonary and Critical Care, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Matthew MightHugh Kaul Precision Medicine Institute, University of Alabama at Birmingham, Birmingham, USA.
David B GoldsteinInstitute of Genomic Medicine, Columbia University Irving Medical Center, New York, USA.
Xinchen WangInstitute of Genomic Medicine, Columbia University Irving Medical Center, New York, USA.
Rachel RamoniOffice of Research and Development, Veterans Health Administration, Washington, D.C., USA.
Kenute MyrieOffice of Research and Development, Veterans Health Administration, Washington, D.C., USA.
Samantha TranDivision of Hematology-Oncology, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Leila GhayouriDivision of Hematology-Oncology, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Sonny TsaiDivision of Hematology-Oncology, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Michelle GeelhoedDivision of Hematology-Oncology, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA.
Danil MakarovDivision of Hematology-Oncology, VA New York Harbor Healthcare System, New York, USA.
Daniel J BeckerDivision of Hematology-Oncology, VA New York Harbor Healthcare System, New York, USA.
Jun-Chieh TsayDivision of Pulmonary and Critical Care, VA New York Harbor Healthcare System, New York, USA.
Melissa DiamondDivision of Hematology-Oncology, VA New York Harbor Healthcare System, New York, USA.
Asha GeorgeDivision of Hematology-Oncology, VA New York Harbor Healthcare System, New York, USA.
Mohammad Al-AjamDivision of Pulmonary and Critical Care, VA New York Harbor Healthcare System, New York, USA.
Pooja BelligundDivision of Pulmonary and Critical Care, VA New York Harbor Healthcare System, New York, USA.
R Bruce MontgomeryDivision of Hematology-Oncology, VA Puget Sound Healthcare System, Seattle, USA.
Elahe A MostaghelGeriatric Research Education and Clinical Care (GRECC), VA Puget Sound Health Care System, Seattle, USA.
Carlie SulpizioDivision of Hematology-Oncology, VA Puget Sound Healthcare System, Seattle, USA.
Zhibao MiVA Cooperative Studies Program Coordinating Center, Point, Perry, MD, USA.
Ellen DemattVA Cooperative Studies Program Coordinating Center, Point, Perry, MD, USA.
Joseph TadalanVA Cooperative Studies Program Coordinating Center, Point, Perry, MD, USA.
Leslie E NormanVA Cooperative Studies Program Coordinating Center, Point, Perry, MD, USA.
Daniel BrionesVA Cooperative Studies Program Coordinating Center, Point, Perry, MD, USA.
Christina E CliseVA Cooperative Studies Program Coordinating Center, Point, Perry, MD, USA.
Zachary W TaylorVA Cooperative Research Pharmacy Coordinating Center, Albuquerque, NM, USA.
Jeffrey R HuminikVA Cooperative Research Pharmacy Coordinating Center, Albuquerque, NM, USA.
Kousick BiswasVA Cooperative Studies Program Coordinating Center, Point, Perry, MD, USA.
Matthew B RettigDivision of Hematology-Oncology, VA Greater Los Angeles Healthcare System, Los Angeles, CA, 90073, USA. matthew.rettig@va.gov.
VA Greater Los Angeles Healthcare System · USVA NY Harbor Healthcare System · USProgram Support Center · USCenter Point · USColumbia University Irving Medical Center · USVA Office of Research and Development · USVA Puget Sound Health Care System · USGeriatric Research Education and Clinical Center · USNew York University · USUniversity of Alabama at Birmingham · US

Funding

va office of research and development COVID19-8900-15
6 · The paper itself

Abstract

backgroundTherapeutic targeting of host-cell factors required for SARS-CoV-2 entry is an alternative strategy to ameliorate COVID-19 severity. SARS-CoV-2 entry into lung epithelium requires the TMPRSS2 cell surface protease. Pre-clinical and correlative data in humans suggest that anti-androgenic therapies can reduce the expression of TMPRSS2 on lung epithelium. Accordingly, we hypothesize that therapeutic targeting of androgen receptor signaling via degarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, will suppress COVID-19 infection and ameliorate symptom severity.

methodsThis is a randomized phase 2, placebo-controlled, double-blind clinical trial in 198 patients to compare efficacy of degarelix plus best supportive care versus placebo plus best supportive care on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19. Enrolled patients must have documented infection with SARS-CoV-2 based on a positive reverse transcriptase polymerase chain reaction result performed on a nasopharyngeal swab and have a severity of illness of level 3-5 (hospitalized but not requiring invasive mechanical ventilation). Patients stratified by age, history of hypertension, and severity are centrally randomized 2:1 (degarelix: placebo). The composite primary endpoint is mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at 15 after randomization. Important secondary endpoints include time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a normal temperature, and the maximum severity of COVID-19 illness. Exploratory analyses aim to assess the association of cytokines, viral load, and various comorbidities with outcome. In addition, TMPRSS2 expression in target tissue and development of anti-viral antibodies will also be investigated. DISCUSSION: In this trial, we repurpose the FDA approved LHRH antagonist degarelix, commonly used for prostate cancer, to suppress TMPRSS2, a host cell surface protease required for SARS-CoV-2 cell entry. The objective is to determine if temporary androgen suppression with a single dose of degarelix improves the clinical outcomes of patients hospitalized due to COVID-19.

trial registrationClinicalTrials.gov NCT04397718. Registered on May 21, 2020.

Indexed as

COVID-19VeteransClinical Trials, Phase II as TopicHospitalizationHumansMaleMulticenter Studies as TopicOligopeptidesRandomized Controlled Trials as TopicSARS-CoV-2Treatment Outcomeacetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamideOligopeptidesAndrogen receptorAndrogen suppressionAnti-androgenCoronavirusCOVID-19Hormone therapySARS-CoV-2TMPRSS2

Identifiers

PMID34225789
PMCPMC8256647
OpenAlexW3178750627

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.