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

Completed · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04397718

Run by

VA Office of Research and Development

People needed

96

Starts

2020-07-06

Expected to finish

2021-06-08

Last updated by the study team

2022-06-06

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Phoenix VA Health Care System, Phoenix, AZ — Phoenix, Arizona, United States
• Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR — Little Rock, Arkansas, United States
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach, California, United States
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — Los Angeles, California, United States
• Miami VA Healthcare System, Miami, FL — Miami, Florida, United States
• St. Louis VA Medical Center John Cochran Division, St. Louis, MO — St Louis, Missouri, United States
• Brooklyn Campus of the VA NY Harbor Healthcare System, Brooklyn, NY — Brooklyn, New York, United States
• Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY — New York, New York, United States
• Philadelphia MultiService Center, Philadelphia, PA — Philadelphia, Pennsylvania, United States
• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States
• Memphis VA Medical Center, Memphis, TN — Memphis, Tennessee, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
• VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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