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

• Status: Completed
• Trial end date: 2021-06-08
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development

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.