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
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.

Terminated
Covid-19 Infection

Drug: Enzalutamide

40 mg oral tablets once daily for a maximum of 28 days.
Other Name: XTANDI

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.

Eligibility Gender
Male
Eligibility Age
Minimum: 50 Years ~ Maximum: N/A
Countries
Switzerland
Locations

Oncology Institute of Southern Switzerland (IOSI)
Bellinzona, Switzerland

Ricardo Pereira Mestre
NCT Number
MeSH Terms
COVID-19