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Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-19

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: NCT04456049
Recruitment Status : Not yet recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
Oncology Institute of Southern Switzerland
Institute of Oncology Research
Institute for Research in Biomedicine
Information provided by (Responsible Party):
Ricardo Pereira Mestre, Ente Ospedaliero Cantonale, Bellinzona

Brief Summary:

High risk outpatient adult males with a confirmed SARS-CoV-2 infection will be included in the study.

Patients will be randomized to receive Enzalutamide with standard of care (SOC) or SOC alone. Enzalutamide will be administered daily p.o. from Day 1 to Day 28 or until confirmed negativization of Nasopharyngeal swap (NPS) Polymerase chain reaction (PCR) (2 consecutive negative samples), whichever occurs first.


Condition or disease Intervention/treatment Phase
COVID-19 Infection Drug: Enzalutamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COVID_ENZA Trial: Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enzalutamide (Xtandi®)
Interventional treatment
Drug: Enzalutamide
40 mg oral tablets once daily for a maximum of 28 days.
Other Name: XTANDI

Active Comparator: Standard of care (SOC)
Supportive treatment
Drug: Enzalutamide
40 mg oral tablets once daily for a maximum of 28 days.
Other Name: XTANDI




Primary Outcome Measures :
  1. Efficacy of Enzalutamide [ Time Frame: 28 days ]
    efficacy of Enzalutamide in decreasing the nasopharyngeal swap SARS-CoV-2 viral load until negativization


Secondary Outcome Measures :
  1. Disease progression [ Time Frame: 28 days ]
    Efficacy of Enzalutamide in controlling disease progression of SARS-CoV-2 viral load

  2. Tollerability of Enzalutamide [ Time Frame: 28 days ]
    Evaluation of Enzalutamide tolerability in terms of incidence and severity grade of side effects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented COVID-19 infection (confirmed by NPS positive PCR for SARS-CoV-2) with mild symptoms not requiring hospitalization
  • First NPS ≤4 days (96 hours) since onset of symptoms
  • Randomization ≤72 hours since first NPS
  • Adult Males aged ≥ 50 years
  • Indication for outpatient treatment but at high risk for complications, at least 1 risk factor (age ≥ 65 years, hypertension, diabetes, cardiovascular disease, active malignancy, COPD)
  • WHO performance status 0-1
  • Adequate hematologic values: haemoglobin ≥ 100 g/L, neutrophils ≥ 1.0 x 10(9)/L, platelets ≥ 150 x 10(9)/L.
  • Adequate hepatic function: ALT and AST ≤ 2.5 x ULN, bilirubin ≤ 1.5 x ULN (exception if Gilbert's syndrome ≤ 2.5 x ULN)
  • Adequate renal function: calculated creatinine clearance ≥ 50 mL/min according to the formula of Cockcroft-Gault
  • Patient is able to swallow the trial drugs and to comply with trial requirements
  • Patient agrees not to father a child during participation in the trial and for 3 months thereafter

Exclusion Criteria:

  • Female sex
  • Moderate to severe COVID-19 symptoms requiring hospitalization
  • Patients requiring inpatient treatment
  • Concurrent antiviral drugs or ongoing interventional clinical trial or any off label drug for COVID-19
  • Patients with ongoing prostate cancer treatment
  • Clinically significant cardiovascular disease including:

    • Myocardial infarction within 6 months prior to registration,
    • Uncontrolled angina within 3 months prior to registration,
    • Congestive heart failure NYHA class III or VI
    • QTc interval > 480 ms
    • History of clinically significant ventricular arrhythmias (e.g. ventricular tachycardia, ventricular fibrillation, torsades de pointes)
    • History of Mobitz II second or third degree heart block without a permanent pacemaker in place
    • Uncontrolled hypertension as indicated by systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg
    • Deep venous thrombosis or pulmonary embolism within 6 months
    • History of cerebrovascular disease
  • Severe concurrent disease, infection or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrolment.
  • Known history of HIV, hepatitis B, hepatitis C
  • Known history of seizures or any conditions that may predispose to seizure. History of loss of consciousness or ischemic cerebrovascular attack within 12 months prior to registration
  • Concurrent anticoagulation with rivaroxaban or warfarin. Concomitant and continuous use of systemic corticosteroids exceeding 10 mg/day of prednisone or a dose equivalent corticosteroid within 14 days before registration.
  • Known hypersensitivity to Enzalutamide or hypersensitivity to any of its components
  • Any concomitant drugs contraindicated for use with Enzalutamide according to the Swissmedic approved product information
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up.

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): NCT04456049


Contacts
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Contact: Ricardo Pereira Mestre, MD +41 (0)91 811 8446 ricardo.pereiramestre@eoc.ch

Locations
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Switzerland
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500
Contact: Ricardo Pereira Mestre, MD    +41 (0)91 811 8446    ricardo.pereiramestre@eoc.ch   
Sponsors and Collaborators
Ricardo Pereira Mestre
Oncology Institute of Southern Switzerland
Institute of Oncology Research
Institute for Research in Biomedicine
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Responsible Party: Ricardo Pereira Mestre, MD, Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT04456049    
Other Study ID Numbers: COVID_ENZA
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No