Trial to Promote Recovery From COVID-19 With Endocrine Therapy

• Status: Withdrawn
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Bicalutamide; Ivermectin

Criteria

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.