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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard of care and bicalutamide 		Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care
  • Drug: Bicalutamide 150 Mg Oral Tablet
    Bicalutamide 150 mg by mouth daily for 7 days
    Other names:
    • Casodex
No Intervention
Standard of care only 		Randomized participants receive standard of care only.

Recruiting Locations

More Details

NCT ID
NCT04374279
Status
Withdrawn
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.