Status:
COMPLETED
Hormonal Intervention for the Treatment in Veterans With COVID-19 Requiring Hospitalization
Lead Sponsor:
VA Office of Research and Development
Conditions:
COVID-19
Eligibility:
MALE
18-85 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04397718
Start Date
July 6 2020
End Date
June 8 2021
Last Update
June 6 2022
Active Locations (14)
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1
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
2
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
3
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
4
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Los Angeles, California, United States, 90073