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Trial to Promote Recovery From COVID-19 With Ivermectin or 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04374279
Recruitment Status : Not yet recruiting
First Posted : May 5, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide or ivermectin. This will be a randomized, open-label study to determine if bicalutamide or ivermectin improves the time to clinical improvement in patients with COVID-19 over historical controls.

Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV 2 Drug: Bicalutamide 150 Mg Oral Tablet Drug: Ivermectin 3Mg Tab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized 1:1:1 to bicalutamide, ivermectin, or standard of care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Promote Recovery From COVID-19 With Ivermectin or Endocrine Therapy
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

Active Comparator: Ivermectin only
Randomized participants receive ivermectin 600ug/kg (maximum dose of 60mg daily) for 3 days (possibility of extension to 6 days if still hospitalized and approved by the Data and Safety Monitoring Board)
Drug: Ivermectin 3Mg Tab
Ivermectin 600 µg/kg (up to a maximum dose of 60mg) by mouth daily for 3 days
Other Names:
  • Soolantra
  • Sklice
  • Stromectol

No Intervention: Standard of care only
Randomized participants receive standard of care only.



Primary Outcome Measures :
  1. Number of participants who have clinical improvement at day 7 after randomization [ Time Frame: up to 7 days ]
    Number 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



Information from the National Library of Medicine

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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:

  • at least 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 or no respiratory symptoms
  • Able to provide informed consent

Exclusion Criteria:

  • Unable to take oral medication
  • Pregnant or breastfeeding
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  • On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
  • Requiring >6L oxygen or respiratory rate >30
  • Taking bicalutamide or any systemic hormonal therapy within one month of study entry
  • Known hypersensitivity to bicalutamide or ivermectin or its components.
  • Cachexia (BMI <18) or hypoalbuminemia (serum albumin ≤3 g/dL)
  • Ophthalmologic disorder (moderate to severe retina or optic nerve pathology; cataracts permitted)
  • A neurologic disorder that may compromise blood brain barrier permeability (stroke/ICH within the previous 90 days, brain tumor, multiple sclerosis, or other neuroinflammatory condition, a neurodegenerative disorder, epilepsy).
  • Concomitant use of medication with predicted drug-drug interaction (for IVM, antifungal azoles, and CYP3A4 inhibitors such as rifampicin; warfarin, while not contraindicated, requires caution due to rare reports of increased INR).

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


Contacts
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Contact: Catherine H Marshall, MD/MPH 410-955-0231 chm@jhmi.edu
Contact: Aliya Lalji, MD 410-502-5101 alalji1@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Contact: Catherine H Marshall, MD/MPH    410-955-0231    chm@jhmi.edu   
Sub-Investigator: Samuel Denmeade, MD         
Sub-Investigator: Vasan Yegnasubramanian, MD/PhD         
Sub-Investigator: Shawn Kwatra, MD         
Sub-Investigator: Lindsey Hayes, MD/PhD         
Sub-Investigator: Jeffrey Rothstein, MD/PhD         
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
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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: May 5, 2020
Last Verified: May 2020
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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Ivermectin
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Antiparasitic Agents
Anti-Infective Agents