Back to resultsHormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization (HITCH)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Degarelix
Saline
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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:
- Androgen receptor antagonists or agonists within 4 weeks,
- Ketoconazole or abiraterone acetate within 2 weeks,
- Estrogens or progestins within 2 weeks,
- 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.
Sites / Locations
- Phoenix VA Health Care System, Phoenix, AZ
- Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
- VA Long Beach Healthcare System, Long Beach, CA
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
- Miami VA Healthcare System, Miami, FL
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO
- Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY
- Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
- Philadelphia MultiService Center, Philadelphia, PA
- Ralph H. Johnson VA Medical Center, Charleston, SC
- Memphis VA Medical Center, Memphis, TN
- VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
- Michael E. DeBakey VA Medical Center, Houston, TX
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo + BSC
Degarelix + BSC
Arm Description
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Outcomes
Primary Outcome Measures
Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.
Secondary Outcome Measures
Time to Clinical Improvement
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.
Inpatient Mortality
Number of patients who died during their hospital stay
Duration of Hospitalization
Length of hospital stay (randomization to discharge)
Duration of Intubation
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.
Time to Normalization of Temperature.
Length of time for temperature to be less than < 37.5 degree Celsius for 48 hours
Maximum Severity of COVID19 Illness.
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.
Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 30.
Full Information
NCT ID
NCT04397718
First Posted
May 14, 2020
Last Updated
June 2, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04397718
Brief Title
Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization
Acronym
HITCH
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
June 8, 2021 (Actual)
Study Completion Date
June 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo + BSC
Arm Type
Placebo Comparator
Arm Description
No active, only placebo (2 - prefilled syringes containing 3 ml of 0.9% saline) plus best supportive care.
Arm Title
Degarelix + BSC
Arm Type
Experimental
Arm Description
Active Degarelix (2 - prefilled syringes containing 3 ml of reconstituted Degarelix concentrated to 40mg/ml) plus best supportive care.
Intervention Type
Drug
Intervention Name(s)
Degarelix
Intervention Description
Degarelix is an FDA-approved drug for prostate cancer
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
09% Saline
Primary Outcome Measure Information:
Title
Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 15
Description
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 15.
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Time to Clinical Improvement
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.
Time Frame
Through discharge (an average of 8 days with a maximum of 2.5 months)
Title
Inpatient Mortality
Description
Number of patients who died during their hospital stay
Time Frame
Through discharge (an average of 8 days with a maximum of 2.5 months)
Title
Duration of Hospitalization
Description
Length of hospital stay (randomization to discharge)
Time Frame
Through discharge (an average of 8 days with a maximum of 2.5 months)
Title
Duration of Intubation
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.
Time Frame
Through discharge (an average of 8 days with a maximum of 2.5 months)
Title
Time to Normalization of Temperature.
Description
Length of time for temperature to be less than < 37.5 degree Celsius for 48 hours
Time Frame
Through discharge (an average of 8 days with a maximum of 2.5 months)
Title
Maximum Severity of COVID19 Illness.
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.
Time Frame
Through discharge (an average of 8 days with a maximum of 2.5 months)
Title
Composite of Mortality, Ongoing Need for Hospitalization, or Mechanical Ventilation at Day 30
Description
Number of Patients who died, had a ongoing need for hospitalization, or was placed on mechanical ventilation at Day 30.
Time Frame
30 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Androgen receptor antagonists or agonists within 4 weeks,
Ketoconazole or abiraterone acetate within 2 weeks,
Estrogens or progestins within 2 weeks,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew B. Rettig, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System, Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-5484
Country
United States
Facility Name
VA Long Beach Healthcare System, Long Beach, CA
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Facility Name
Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11209
Country
United States
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Philadelphia MultiService Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
Memphis VA Medical Center, Memphis, TN
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35438754
Citation
Nickols NG, Mi Z, DeMatt E, Biswas K, Clise CE, Huggins JT, Maraka S, Ambrogini E, Mirsaeidi MS, Levin ER, Becker DJ, Makarov DV, 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. Effect of Androgen Suppression on Clinical Outcomes in Hospitalized Men With COVID-19: The HITCH Randomized Clinical Trial. JAMA Netw Open. 2022 Apr 1;5(4):e227852. doi: 10.1001/jamanetworkopen.2022.7852.
Results Reference
result
PubMed Identifier
34225789
Citation
Nickols NG, Goetz MB, Graber CJ, Bhattacharya D, Soo Hoo G, Might M, Goldstein DB, Wang X, Ramoni R, Myrie K, Tran S, Ghayouri L, Tsai S, Geelhoed M, Makarov D, Becker DJ, Tsay JC, Diamond M, George A, Al-Ajam M, Belligund P, Montgomery RB, Mostaghel EA, Sulpizio C, Mi Z, Dematt E, Tadalan J, Norman LE, Briones D, Clise CE, Taylor ZW, Huminik JR, Biswas K, Rettig MB. 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. Trials. 2021 Jul 5;22(1):431. doi: 10.1186/s13063-021-05389-0.
Results Reference
derived
Learn more about this trial
Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization
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