Trial to Promote Recovery From COVID-19 With Endocrine Therapy

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

COVID-19 SARS-CoV 2

Interventions

Bicalutamide 150 Mg Oral TabletDRUG

Bicalutamide 150 mg by mouth daily for 7 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: up to 7 days

Secondary Outcomes

All-cause mortality

Number of participants deceased for any cause

Time frame: 28 days

Duration of hospitalization

Number of calendar days in the hospital

Time frame: up to 60 days

Percentage of patients needing upgrade to the intermediate care unit (IMC)

Time frame: up to 60 days

Duration of IMC stay

Number of calendar days in IMC

Time frame: up to 60 days

Percentage of patients needing upgrade to the intensive care unit (ICU)

Time frame: up to 60 days

Duration of ICU stay

Number of calendar days in ICU

Time frame: up to 60 days

Data from ClinicalTrials.gov

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