Trial to Promote Recovery From COVID-19 With Endocrine Therapy

A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy

Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.

Inclusion Criteria:

• ≥18 years of age
• COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=3 days from enrollment
• Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms
• Able to provide informed consent

Exclusion Criteria:

• Unable to take oral medication
• Pregnant or breastfeeding
• On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
• Requiring ≥6L oxygen or respiratory rate ≥30
• Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry
• Known hypersensitivity to bicalutamide or its components.
• A past medical history of cirrhosis or AST/ALT/Alk phos/bilirubin > 3x the upper limit of normal
• Patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction < 40%
• Patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.