Status:
TERMINATED
Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
Lead Sponsor:
Ricardo Pereira Mestre
Collaborating Sponsors:
Oncology Institute of Southern Switzerland
Institute of Oncology Research
Conditions:
COVID-19 Infection
Eligibility:
MALE
50+ years
Phase:
PHASE2
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. Enz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04456049
Start Date
August 24 2020
End Date
June 9 2021
Last Update
August 10 2022
Active Locations (1)
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1
Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland, 6500