Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Withdrawn before enrolling · Phase 2
Conditions studied: COVID-19, SARS-CoV 2
In brief
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.
Key facts
- Study ID
- NCT04374279
- Run by
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- People needed
- 0
- Starts
- 2021-04-01
- Expected to finish
- 2022-01-01
- Last updated by the study team
- 2021-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥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
You may not qualify if…
- 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.
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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