Trial to Promote Recovery From COVID-19 With Endocrine Therapy (RECOVER)

Johns Hopkins Medicine

Status and phase

Withdrawn

Phase 2

Conditions

COVID-19

SARS-CoV 2

Treatments

Drug: Bicalutamide 150 Mg Oral Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT04374279

IRB00249425 (Other Identifier)

COV2003

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.