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

COVID-19 Infection Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04456049
• Other study ID #: COVID_ENZA
• Status: Terminated
• Phase: Phase 2
• Start date: August 24, 2020
• Est. completion date: June 9, 2021

Study information

• Verified date: August 2022
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 9, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection

Intervention

Drug:
• Enzalutamide
40 mg oral tablets once daily for a maximum of 28 days.

Locations

Country	Name	City	State
Switzerland	Oncology Institute of Southern Switzerland (IOSI)	Bellinzona

Sponsors (4)

Lead Sponsor	Collaborator
Ricardo Pereira Mestre	Institute for Research in Biomedicine, Institute of Oncology Research, Oncology Institute of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Secondary	Tollerability of Enzalutamide by identifying Adverse Events	Evaluation of Enzalutamide tolerability in terms of incidence and severity grade of side effects	28 days
Secondary	Disease progression by unresolved SARS-CoV-2 viral expression after treatment	Efficacy of Enzalutamide in controlling disease progression of SARS-CoV-2 viral load	28 days