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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

Short name HITCH

NCTNCT04397718 (opens ClinicalTrials.gov in a new tab)Other idCOVID19-8900-15
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
96 participants (actual)
Sponsor
VA Office of Research and Development · Fed
Design
Randomized · Double masking
Countries
1 country

United States

Start
6 Jul 2020
Primary completion
8 Jun 2021
Completion
8 Jun 2021
First posted
21 May 2020
Last update posted
6 Jun 2022
Conditions
COVID-19

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202020212022
  1. Ph 2

    HITCH

    NCT04397718

    6 Jul 2020 to 8 Jun 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine if temporary androgen suppression improves the clinical outcomes of Veterans who are hospitalized to an acute care ward due to COVID-19.

Interventions

  • DegarelixDrug
  • SalineOther

Arms2

  • Placebo comparator

    Placebo + BSC

    No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.

  • Experimental

    Degarelix + BSC

    Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15

    Time frame · 15 days

    Registry description

    Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.

Secondary outcomes(7)

  1. Time to Clinical Improvement

    Time frame · Through discharge (an average of 8 days with a maximum of 2.5 months)

    Registry description

    Time to clinical improvement as defined by a decline of 2 categories or more from the baseline modified 7-category ordinal scale of clinical status of hospitalized influenza patients or hospital discharge, whichever comes first. Participants whose condition worsened, who died, or who withdrew from the study without clinical improvement were censored. The 7-categories were defined as: 1: Not hospitalized with resumption of normal activities; 2: Not hospitalized, but unable to resume normal activities; 3: Hospitalization, not requiring supplemental oxygen; 4: Hospitalization, requiring supplemental oxygen; 5: Hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6: Hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7: Death.

  2. Inpatient Mortality

    Time frame · Through discharge (an average of 8 days with a maximum of 2.5 months)

    Registry description

    Number of patients who died during their hospital stay

  3. Duration of Hospitalization

    Time frame · Through discharge (an average of 8 days with a maximum of 2.5 months)

    Registry description

    Length of hospital stay (randomization to discharge)

  4. Duration of Intubation

    Time frame · Through discharge (an average of 8 days with a maximum of 2.5 months)

    Registry description

    Length of time on mechanical ventilation. Length of mechanical ventilation imputed to maximum length (50 days) for patients who died on mechanical ventilation or who were on mechanical ventilation, but date removed was unknown. Length of mechanical ventilation imputed to 0 for patients never on mechanical ventilation.

  5. Time to Normalization of Temperature.

    Time frame · Through discharge (an average of 8 days with a maximum of 2.5 months)

    Registry description

    Length of time for temperature to be less than \< 37.5 degree Celsius for 48 hours

  6. Maximum Severity of COVID19 Illness.

    Time frame · Through discharge (an average of 8 days with a maximum of 2.5 months)

    Registry description

    Maximum severity score on the modified 7-category ordinal scale of clinical status of hospitalized influenza patients. The 7-categories were defined as: 1: Not hospitalized with resumption of normal activities; 2: Not hospitalized, but unable to resume normal activities; 3: Hospitalization, not requiring supplemental oxygen; 4: Hospitalization, requiring supplemental oxygen; 5: Hospitalization, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation; 6: Hospitalization, requiring extracorporeal membrane oxygenation and/or invasive mechanical ventilation; 7: Death.

  7. Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30

    Time frame · 30 days

    Registry description

    Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 30.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 15 days

Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15

GroupValue (Participants)
Placebo + BSC9
Degarelix + BSC19
Secondary and other outcome results(7)
Secondary outcomeMedian· Through discharge (an average of 8 days with a maximum of 2.5 months)

Time to Clinical Improvement

GroupValue (Days)
Placebo + BSC5.50
Degarelix + BSC7.00
Secondary outcomeCount of participants· Through discharge (an average of 8 days with a maximum of 2.5 months)

Inpatient Mortality

GroupValue (Participants)
Placebo + BSC6
Degarelix + BSC11
Secondary outcomeMedian· Through discharge (an average of 8 days with a maximum of 2.5 months)

Duration of Hospitalization

GroupValue (Days)
Placebo + BSC5.00
Degarelix + BSC6.00
Secondary outcomeMedian· Through discharge (an average of 8 days with a maximum of 2.5 months)

Duration of Intubation

GroupValue (Days)
Placebo + BSC0.00
Degarelix + BSC0.00
Secondary outcomeMedian· Through discharge (an average of 8 days with a maximum of 2.5 months)

Time to Normalization of Temperature.

GroupValue (Days)
Placebo + BSC5.00
Degarelix + BSC3.00
Secondary outcomeCount of participants· Through discharge (an average of 8 days with a maximum of 2.5 months)

Maximum Severity of COVID19 Illness.

GroupValue (Participants)
Placebo + BSC4
Degarelix + BSC8
Secondary outcomeCount of participants· 30 days

Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30

GroupValue (Participants)
Placebo + BSC7
Degarelix + BSC15

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo + BSCNo active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care. Saline: 09% Saline7 / 3411 / 348 / 34
Degarelix + BSCActive Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care. Degarelix: Degarelix is an FDA-approved drug for prostate cancer11 / 6219 / 6213 / 62

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

6 results

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

Nickols et al. 2022JAMA network opencited by 21

PMID 35438754PMC9020208DOI 10.1001/jamanetworkopen.2022.7852PUB-35438754

CC BY6 results
Download PDFSee results (6)

More studies

1 study on this page

Indexing hint: Clinical trial · 2021

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.

Nickols et al. 2021Trialscited by 7

PMID 34225789PMC8256647DOI 10.1186/s13063-021-05389-0PUB-34225789

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male Veterans admitted to a VA hospital. * Age \> 18 * Hospitalized on an acute care ward with a diagnosis of COVID-19 contributing to hospitalization. * Positive RT-PCR assay for SARS-CoV-2 on a nasopharyngeal swab sample. * Severity of illness of level 3, 4 or 5 on the influenza severity scale (see Appendix A) at the time of randomization. * The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial. Exclusion Criteria: * History of severe hypersensitivity to degarelix or any component of their respective formulation. * History of congenital long QT syndrome or known history of prolonged QT interval corrected by the Fridericia correction formula (QTcF) \> 500 msec on electrocardiogram performed at screening. * Planned discharge within 24 hours of treatment initiation. * Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment. * Ongoing usage of a Class IA or Class III antiarrhythmic agent. At least 5 half lives must elapse since any prior use of a Class IA or III antiarrhythmic agent prior to administration of study drug. --Baseline electrolyte abnormalities of Grade 3 or higher (based on CTCAE v5.0 criteria). Patients may be included if baseline electrolyte abnormalities are corrected to Grade 2 or lower prior to study drug administration. * Myocardial infarction in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease. * Enrollment in another investigational study within 30 days of Day 1. * Known psychiatric or substance abuse disorder that would interfere with the requirements of the trial. * Child-Pugh Class C liver disease. * Use of any of the following hormonal agents within Day 1 of treatment: 1. Androgen receptor antagonists or agonists within 4 weeks, 2. Ketoconazole or abiraterone acetate within 2 weeks, 3. Estrogens or progestins within 2 weeks, 4. Herbal products that contain hormonally active agents within 2 weeks. * Unwilling or unable to comply with the study protocol. * Any condition, which in the opinion of the investigator, would preclude participation in the trial.

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