Status:
WITHDRAWN
Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
COVID-19
SARS-CoV 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 dete...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04374279
Start Date
April 1 2021
End Date
January 1 2022
Last Update
March 5 2021
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231