Trial to Promote Recovery From COVID-19 With Endocrine Therapy

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy

Conditions
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COVID-19, SARS-CoV 2

Intervention / Treatment
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* Drug: Bicalutamide 150 Mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care and bicalutamide<br>Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care | Drug: Bicalutamide 150 Mg Oral Tablet<br>* Bicalutamide 150 mg by mouth daily for 7 days<br>* Other names: Casodex;|
| No Intervention: Standard of care only<br>Randomized participants receive standard of care only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who have clinical improvement at day 7 after randomization | 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 | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Number of participants deceased for any cause | 28 days | 
| Duration of hospitalization | Number of calendar days in the hospital | up to 60 days | 
| Percentage of patients needing upgrade to the intermediate care unit (IMC) |  | up to 60 days | 
| Duration of IMC stay | Number of calendar days in IMC | up to 60 days | 
| Percentage of patients needing upgrade to the intensive care unit (ICU) |  | up to 60 days | 
| Duration of ICU stay | Number of calendar days in ICU | up to 60 days | 
| Number of participants requiring mechanical ventilation |  | up to 60 days | 
| Duration of mechanical ventilation | Number of calendar days requiring mechanical ventilation | up to 60 days | 
| Number of participants experiencing adverse events | 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 | up to 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, COVID-19, Coronavirus, SARS-COV-2