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

NCT ID: NCT04456049

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-24
• Study Completion Date: 2021-06-09

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.

Conditions

COVID-19 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enzalutamide (Xtandi®)

Interventional treatment

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

40 mg oral tablets once daily for a maximum of 28 days.

Standard of care (SOC)

Supportive treatment

Group Type: ACTIVE_COMPARATOR

Enzalutamide

Intervention Type: DRUG

40 mg oral tablets once daily for a maximum of 28 days.

Interventions

Enzalutamide

40 mg oral tablets once daily for a maximum of 28 days.

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Oncology Institute of Southern Switzerland

OTHER

Sponsor Role: collaborator

Institute of Oncology Research

UNKNOWN

Sponsor Role: collaborator

Institute for Research in Biomedicine

UNKNOWN

Sponsor Role: collaborator

Ricardo Pereira Mestre

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Pereira Mestre

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, , Switzerland

Countries

Switzerland

Other Identifiers

COVID_ENZA

Identifier Type: -

Identifier Source: org_study_id