Trial to Promote Recovery From COVID-19 With Endocrine Therapy

NCT04374279 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: COV2003IRB00249425
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV 2

Keywords

COVID-19; Coronavirus; COVID; SARS-COV-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• All-cause mortality

  28 days

• Duration of hospitalization

  up to 60 days

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

  up to 60 days

• Duration of IMC stay

  up to 60 days

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

  up to 60 days

Study Arms (2)

Standard of care and bicalutamide

ACTIVE COMPARATOR

Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care

Drug: Bicalutamide 150 Mg Oral Tablet

Standard of care only

NO INTERVENTION

Randomized participants receive standard of care only.

Interventions

Bicalutamide 150 Mg Oral Tablet DRUG

Bicalutamide 150 mg by mouth daily for 7 days

Also known as: Casodex

Standard of care and bicalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Catherine H Marshall, MD/MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 5, 2020
• Study Start: April 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)