Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Degarelix; Saline
Intervention description: Degarelix is an FDA-approved drug for prostate cancer; 09% Saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: Male
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

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:

               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.