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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374279
Recruitment Status : Withdrawn (Limited resources.)
First Posted : May 5, 2020
Last Update Posted : March 5, 2021
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Drug: Bicalutamide 150 Mg Oral Tablet Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

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Arms and Interventions
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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 Name: Casodex
No Intervention: Standard of care only
Randomized participants receive standard of care only.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants who have clinical improvement at day 7 after randomization [ Time Frame: up to 7 days ]
    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 :
  1. All-cause mortality [ Time Frame: 28 days ]
    Number of participants deceased for any cause

  2. Duration of hospitalization [ Time Frame: up to 60 days ]
    Number of calendar days in the hospital

  3. Percentage of patients needing upgrade to the intermediate care unit (IMC) [ Time Frame: up to 60 days ]
  4. Duration of IMC stay [ Time Frame: up to 60 days ]
    Number of calendar days in IMC

  5. Percentage of patients needing upgrade to the intensive care unit (ICU) [ Time Frame: up to 60 days ]
  6. Duration of ICU stay [ Time Frame: up to 60 days ]
    Number of calendar days in ICU

  7. Number of participants requiring mechanical ventilation [ Time Frame: up to 60 days ]
  8. Duration of mechanical ventilation [ Time Frame: up to 60 days ]
    Number of calendar days requiring mechanical ventilation

  9. Number of participants experiencing adverse events [ Time Frame: up to 60 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04374279


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Catherine H Marshall, MD/MPH Johns Hopkins University
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04374279    
Other Study ID Numbers: COV2003
IRB00249425 ( Other Identifier: JHM IRB )
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
COVID-19
Coronavirus
COVID
SARS-COV-2
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents