Trial to Promote Recovery From COVID-19 With Endocrine Therapy
NCT ID: NCT04374279
Last Updated: 2021-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-04-30
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of care and bicalutamide
Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care
Bicalutamide 150 Mg Oral Tablet
Bicalutamide 150 mg by mouth daily for 7 days
Standard of care only
Randomized participants receive standard of care only.
No interventions assigned to this group
Interventions
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Bicalutamide 150 Mg Oral Tablet
Bicalutamide 150 mg by mouth daily for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Catherine H Marshall, MD/MPH
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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Other Identifiers
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IRB00249425
Identifier Type: OTHER
Identifier Source: secondary_id
COV2003
Identifier Type: -
Identifier Source: org_study_id
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