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

Primary Purpose

COVID-19, SARS-CoV 2

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bicalutamide 150 Mg Oral Tablet
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Coronavirus, COVID, SARS-COV-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Standard of care and bicalutamide

Standard of care only

Arm Description

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

Randomized participants receive standard of care only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause mortality
Number of participants deceased for any cause
Duration of hospitalization
Number of calendar days in the hospital
Percentage of patients needing upgrade to the intermediate care unit (IMC)
Duration of IMC stay
Number of calendar days in IMC
Percentage of patients needing upgrade to the intensive care unit (ICU)
Duration of ICU stay
Number of calendar days in ICU
Number of participants requiring mechanical ventilation
Duration of mechanical ventilation
Number of calendar days requiring mechanical ventilation
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

Full Information

First Posted
May 4, 2020
Last Updated
March 2, 2021
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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1. Study Identification

Unique Protocol Identification Number
NCT04374279
Brief Title
Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Acronym
RECOVER
Official Title
A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Limited resources.
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV 2
Keywords
COVID-19, Coronavirus, COVID, SARS-COV-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care and bicalutamide
Arm Type
Active Comparator
Arm Description
Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care
Arm Title
Standard of care only
Arm Type
No Intervention
Arm Description
Randomized participants receive standard of care only.
Intervention Type
Drug
Intervention Name(s)
Bicalutamide 150 Mg Oral Tablet
Other Intervention Name(s)
Casodex
Intervention Description
Bicalutamide 150 mg by mouth daily for 7 days
Primary Outcome Measure Information:
Title
Percentage of participants who have clinical improvement at day 7 after randomization
Description
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 Outcome Measure Information:
Title
All-cause mortality
Description
Number of participants deceased for any cause
Time Frame
28 days
Title
Duration of hospitalization
Description
Number of calendar days in the hospital
Time Frame
up to 60 days
Title
Percentage of patients needing upgrade to the intermediate care unit (IMC)
Time Frame
up to 60 days
Title
Duration of IMC stay
Description
Number of calendar days in IMC
Time Frame
up to 60 days
Title
Percentage of patients needing upgrade to the intensive care unit (ICU)
Time Frame
up to 60 days
Title
Duration of ICU stay
Description
Number of calendar days in ICU
Time Frame
up to 60 days
Title
Number of participants requiring mechanical ventilation
Time Frame
up to 60 days
Title
Duration of mechanical ventilation
Description
Number of calendar days requiring mechanical ventilation
Time Frame
up to 60 days
Title
Number of participants experiencing adverse events
Description
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
Time Frame
up to 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine H Marshall, MD/MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Trial to Promote Recovery From COVID-19 With Endocrine Therapy

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