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Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1

Primary Purpose

COVID-19 Infection

Status
Terminated
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Enzalutamide
Sponsored by
Ricardo Pereira Mestre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 Infection

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Oncology Institute of Southern Switzerland (IOSI)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enzalutamide (Xtandi®)

Standard of care (SOC)

Arm Description

Interventional treatment

Supportive treatment

Outcomes

Primary Outcome Measures

Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression
efficacy of Enzalutamide in decreasing the nasopharyngeal swap SARS-CoV-2 viral load until negativization

Secondary Outcome Measures

Tollerability of Enzalutamide by identifying Adverse Events
Evaluation of Enzalutamide tolerability in terms of incidence and severity grade of side effects
Disease progression by unresolved SARS-CoV-2 viral expression after treatment
Efficacy of Enzalutamide in controlling disease progression of SARS-CoV-2 viral load

Full Information

First Posted
July 1, 2020
Last Updated
August 7, 2022
Sponsor
Ricardo Pereira Mestre
Collaborators
Oncology Institute of Southern Switzerland, Institute of Oncology Research, Institute for Research in Biomedicine
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1. Study Identification

Unique Protocol Identification Number
NCT04456049
Brief Title
Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
June 9, 2021 (Actual)
Study Completion Date
June 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ricardo Pereira Mestre
Collaborators
Oncology Institute of Southern Switzerland, Institute of Oncology Research, Institute for Research in Biomedicine

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide (Xtandi®)
Arm Type
Experimental
Arm Description
Interventional treatment
Arm Title
Standard of care (SOC)
Arm Type
Active Comparator
Arm Description
Supportive treatment
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
XTANDI
Intervention Description
40 mg oral tablets once daily for a maximum of 28 days.
Primary Outcome Measure Information:
Title
Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression
Description
efficacy of Enzalutamide in decreasing the nasopharyngeal swap SARS-CoV-2 viral load until negativization
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Tollerability of Enzalutamide by identifying Adverse Events
Description
Evaluation of Enzalutamide tolerability in terms of incidence and severity grade of side effects
Time Frame
28 days
Title
Disease progression by unresolved SARS-CoV-2 viral expression after treatment
Description
Efficacy of Enzalutamide in controlling disease progression of SARS-CoV-2 viral load
Time Frame
28 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Oncology Institute of Southern Switzerland (IOSI)
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1

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