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

Ricardo Pereira Mestre

Status and phase

Terminated

Phase 2

Conditions

COVID-19 Infection

Treatments

Drug: Enzalutamide

Study type

Interventional

Funder types

Other

Identifiers

NCT04456049

COVID_ENZA

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

Male

Ages

50+ years old

Volunteers

No 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.