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

  • STATUS
    Recruiting
  • days left to enroll
    11
  • participants needed
    198
  • sponsor
    VA Office of Research and Development
Updated on 1 November 2020
diabetes
cancer
COPD
covid-19
SARS
nasopharyngeal swab

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.

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.

Details
Treatment Saline, Degarelix
Clinical Study IdentifierNCT04397718
SponsorVA Office of Research and Development
Last Modified on1 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Are you male?
Do you have any of these conditions: Covid-19 or COVID19 or *COVID-19?
Male Veterans admitted to a VA hospital
Age 18 and 85; patients > 85 can be enrolled if there is no history of chronic obstructive pulmonary disease (COPD), asthma, cardiovascular disease, hypertension, diabetes mellitus or active malignancy
Hospitalized on an acute care ward due to COVID-19
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
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
Active use of anti-viral therapies directed at SARS-CoV-2, except for remdesivir at the discretion of the treating physician. Antibiotics not directed at SARS-CoV-2 are allowed
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
Any concurrent use of systemic glucocorticoids within 30 days of Day 1 (day of study drug administration). Except with used in the treatment of COVID-19 eg Dexamethasone
Use of hydroxychloroquine, chloroquine or azithromycin within 30 days of Day 1
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
Use of any drug known to prolong QT interval within 30 days of Day 1
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
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