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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04397718
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
CoVID19 Drug: Degarelix Other: Saline Phase 2

Detailed Description:

A novel coronavirus, now termed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), arose late in 2019. The first confirmed cases occurred in December in Wuhan, Hubei province, China. It now infects people on six continents, spreading person to person. The World Health Organization (WHO) classified it as a global pandemic on March 11, 2020. As of April 6, 2020, there are more than 1.2 million confirmed cases and more than 70,000 deaths attributed to this virus. Every person on Earth, as well as every United States Veteran, is at risk. This is the emergent public health threat of our time.

SARS-CoV-2 is a singled stranded RNA virus related to severe acute respiratory syndrome-related coronavirus (SARS-CoV-1). SARS-CoV-2 is thought to be transmissible largely by respiratory droplets or direct contact, but might also be transmitted through aerosolization. SARS-CoV-2 disease severity ranges from no to minimal symptoms, mildly symptomatic with cough and dyspnea, to severe respiratory distress with multi-organ failure requiring admission to an intensive care unit and emergent ventilator support. Although data are evolving, the severity of illness varies with age, co-existing comorbidities, and biological sex, with older age, people with pre-existing cardiovascular disease, and males manifesting greater disease severity.

A worldwide effort is in place to contain and suppress human-to-human transmission. These public-health strategies aim to slow the rate of spread and reduce the burden on critical care infrastructure. However, there is also a need effective therapeutics. Vaccine trials are underway but potential approvals are at least a year away. Development of new drugs de novo to treat SARS2-CoV-2 will likely take even longer. Thus, the most expedient therapeutic strategy to confront this pandemic will repurpose existing FDA-approved therapeutics. One potential strategy targets viral components directly, using existing antivirals and anti-infectives currently used for other diseases. Such efforts include trials of hydroxychloroquine, remdesivir, and ribavirin. Another strategy involves targeting the human proteins, rather than viral proteins, required for SARS CoV-2 entry and replication.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 6, 2020
Estimated Primary Completion Date : December 6, 2020
Estimated Study Completion Date : December 6, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Degarelix

Arm Intervention/treatment
Placebo Comparator: Placebo + BSC
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Other: Saline
09% Saline

Experimental: Degarelix + BSC
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Drug: Degarelix
Degarelix is an FDA-approved drug for prostate cancer




Primary Outcome Measures :
  1. A composite endpoint of mortality, ongoing need for hospitalization, or requirement for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) at Day 15 after randomization. [ Time Frame: 15 days ]
    Determine if degarelix + best supportive care (BSC) as compared to placebo + BSC reduces the composite endpoint of mortality, ongoing need for hospitalization, or requirement for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) at Day 15 after randomization.


Secondary Outcome Measures :
  1. Time to clinical improvement [ Time Frame: Through study completion/discharge (an average of 30 days with a maximum of 4 months) ]
    Determine if degarelix + BSC as compared to placebo + BSC reduces time to clinical improvement as defined by a decline of 2 categories or more from the baseline on the modified 7-category ordinal scale of clinical status of hospitalized influenza patients or hospital discharge whichever comes first.

  2. Inpatient mortality [ Time Frame: Through study completion/discharge (an average of 30 days with a maximum of 4 months) ]
    Determine if degarelix + BSC as compared to placebo + BSC reduces inpatient mortality.

  3. Duration of hospitalization [ Time Frame: Through study completion/discharge (an average of 30 days with a maximum of 4 months) ]
    Determine if degarelix + BSC as compared to placebo + BSC shortens the duration of hospitalization.

  4. Duration of intubation for mechanical ventilation. [ Time Frame: Through study completion/discharge (an average of 30 days with a maximum of 4 months) ]
    Determine if degarelix + BSC as compared to placebo + BSC shortens the duration of intubation for mechanical ventilation.

  5. Time to normalization of temperature. [ Time Frame: Through study completion/discharge (an average of 30 days with a maximum of 4 months) ]
    Determine if degarelix + BSC as compared to placebo + BSC reduces the time to normalization of temperature (T < 37.5 for 48 hours)

  6. Maximum severity of COVID19 illness. [ Time Frame: Through study completion/discharge (an average of 30 days with a maximum of 4 months) ]
    Determine if degarelix + BSC as compared to placebo + BSC reduces the maximum severity of COVID-19 illness based on the modified 7-category ordinal scale of clinical status of hospitalized influenza patients. Score range 1-7, higher scores equals worse outcome.

  7. A composite endpoint of mortality, ongoing need for hospitalization, or requirement for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) at Day 30 after randomization. [ Time Frame: 30 days ]
    Determine if degarelix + best supportive care (BSC) as compared to placebo + BSC reduces the composite endpoint of mortality, ongoing need for hospitalization, or requirement for mechanical ventilation/extracorporeal membrane oxygenation (ECMO) at Day 30 after randomization.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male Veterans admitted to a VA hospital.
  • Age 18 and 85; patients > 85 can be enrolled if there is no history of chronic obstructive pulmonary disease (COPD), asthma, cardiovascular disease, hypertension, diabetes mellitus or active malignancy.
  • Hospitalized on an acute care ward due to COVID-19.
  • 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.
  • Active use of anti-viral therapies directed at SARS-CoV-2, except for remdesivir at the discretion of the treating physician. Antibiotics not directed at SARS-CoV-2 are allowed.
  • 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.
  • Any concurrent use of systemic glucocorticoids within 30 days of Day 1 (day of study drug administration). Except with used in the treatment of COVID-19 eg Dexamethasone.
  • Use of hydroxychloroquine, chloroquine or azithromycin within 30 days of Day 1.
  • 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.�
  • Use of any drug known to prolong QT interval within 30 days of Day 1.�
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397718


Contacts
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Contact: Matthew B Rettig, MD (310) 478-3711 matthew.rettig@va.gov
Contact: Nicholas G Nickols, MD PhD (310) 478-3711 nicholas.nickols@va.gov

Locations
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United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA Recruiting
Los Angeles, California, United States, 90073
Contact: Matthew B Rettig, MD    310-478-3711    matthew.rettig@va.gov   
Contact: Nicholas G Nickols, MD PhD    (310) 478-3711    nicholas.nickols@va.gov   
Principal Investigator: Matthew B. Rettig, MD         
United States, New York
Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY Not yet recruiting
Brooklyn, New York, United States, 11209
Contact: Daniel Becker, MD    212-686-7500 ext 3303    Daniel.Becker2@va.gov   
Contact: Mohammad Al-Jam, MD    7186303722    Mohammad.AlJam@va.gov   
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY Not yet recruiting
New York, New York, United States, 10010
Contact: Daniel Becker, MD    212-686-7500 ext 3303    Daniel.Becker2@va.gov   
Contact: Tsay Jun-Chieh    2126867500    Jun-Chieh@va.gov   
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA Recruiting
Seattle, Washington, United States, 98108
Contact: Bruce Montgomery, MD    206-598-0860    Bruce.Montgomery@va.gov   
Contact: Elahe Mostaghel, MD    2022771657    Elahe.Mostaghel@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Matthew B. Rettig, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04397718    
Other Study ID Numbers: COVID19-8900-15
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes