NCT04456049终止2 期
COVID_ENZA Trial: Randomized Open Label Phase II Study to Evaluate the Efficacy of Enzalutamide in High Risk Male Outpatients With COVID-1
Ricardo Pereira Mestre1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2020年8月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Enzalutamide (Xtandi®)
Experimental
Interventional treatment
干预措施: Enzalutamide (Drug)
Standard of care (SOC)
Active Comparator
Supportive treatment
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Efficacy of Enzalutamide by decreasing SARS-CoV-2 viral expression
时间窗: 28 days
efficacy of Enzalutamide in decreasing the nasopharyngeal swap SARS-CoV-2 viral load until negativization
次要结局
- Tollerability of Enzalutamide by identifying Adverse Events(28 days)
- Disease progression by unresolved SARS-CoV-2 viral expression after treatment(28 days)
研究者
Ricardo Pereira Mestre
MD
Ente Ospedaliero Cantonale, Bellinzona
研究点 (1)
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