Trial to Promote Recovery From COVID-19 With Endocrine Therapy (RECOVER)

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

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 Overview

• Status: Withdrawn
• Conditions: COVID-19; SARS-CoV 2
• Intervention / Treatment: Drug: Bicalutamide 150 Mg Oral Tablet

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Investigators: Principal Investigator: Catherine H Marshall, MD/MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; COVID; SARS-COV-2
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Androgen Antagonists; Bicalutamide
• Other Study ID Numbers: COV2003; IRB00249425 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No