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

NCT04456049 | Terminated Phase 2

• 1 other identifier: COVID_ENZA
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 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.

Conditions

COVID-19 Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tollerability of Enzalutamide by identifying Adverse Events

  28 days

• Disease progression by unresolved SARS-CoV-2 viral expression after treatment

  28 days

Study Arms (2)

Enzalutamide (Xtandi®)

EXPERIMENTAL

Interventional treatment

Drug: Enzalutamide

Standard of care (SOC)

ACTIVE COMPARATOR

Supportive treatment

Drug: Enzalutamide

Interventions

Enzalutamide DRUG

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

Also known as: XTANDI

Enzalutamide (Xtandi®); Standard of care (SOC)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ricardo Pereira Mestre: lead
• Oncology Institute of Southern Switzerland: collaborator
• Institute of Oncology Research: collaborator
• Institute for Research in Biomedicine: collaborator

Study Sites (1)

Oncology Institute of Southern Switzerland (IOSI)

Bellinzona, 6500, Switzerland

Location

MeSH Terms

Conditions

COVID-19

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 2, 2020
• Study Start: August 24, 2020
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

CH (1)