Trial to Promote Recovery From COVID-19 With Endocrine Therapy
- Registration Number
- NCT04374279
- 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 determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- ≥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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care and bicalutamide Bicalutamide 150 Mg Oral Tablet Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care
- Primary Outcome Measures
Name Time Method Percentage of participants who have clinical improvement at day 7 after randomization up to 7 days Percentage of participants who are discharged from the hospital or if they have had at least a 2-point improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. The WHO clinical improvement scale has a score range of 0-8 where, 0= uninfected, 1= ambulatory with no limitation of activities; 2= ambulatory with limitations to activities; 3= hospitalized, mild disease, with no oxygen therapy; 4= hospitalized, mild disease, with oxygen by mask or nasal prongs; 5= hospitalized, severe disease, with non-invasive ventilation or high-flow oxygen; 6= hospitalized, severe disease, with intubation and mechanical ventilation; 7= hospitalized, severe disease, with ventilation and additional organ support (pressors, dialysis, ECMO); 8= death
- Secondary Outcome Measures
Name Time Method Percentage of patients needing upgrade to the intermediate care unit (IMC) up to 60 days Duration of mechanical ventilation up to 60 days Number of calendar days requiring mechanical ventilation
Percentage of patients needing upgrade to the intensive care unit (ICU) up to 60 days All-cause mortality 28 days Number of participants deceased for any cause
Duration of IMC stay up to 60 days Number of calendar days in IMC
Duration of hospitalization up to 60 days Number of calendar days in the hospital
Number of participants experiencing adverse events up to 60 days Number of participants who are COVID-19 positive, experiencing adverse events as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Duration of ICU stay up to 60 days Number of calendar days in ICU
Number of participants requiring mechanical ventilation up to 60 days
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States