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.
Drug: Bicalutamide 150 Mg Oral Tablet
Bicalutamide 150 mg by mouth daily for 7 days
Other Name: Casodex
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.
Johns Hopkins Hospital
Baltimore, Maryland, United States
Catherine H Marshall, MD/MPH, Principal Investigator
Johns Hopkins University