A Prospective, Multicenter, Randomized PHASE II Clinical Trial of Enzalutamide Treatment to Decrease the Morbidity in Patients With Corona Virus Disease 2019 (COVID-19)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Time to improvement of disease
研究概览
简要总结
COVID-19 is a disease with high rate of morbidity if symptomatic. There is a great need of treatments to decrease the severity. The vast majority of patients needing intensive care are men, and this may be due to the androgens, either by regulation of TMPRSS2, necessary for virus internalization, or other mechanisms. Enzalutamide is an antiandrogen inhibiting the expression of androgen regulated proteins, such as TMPRSS2. The aim of this trial is to evaluate a possible beneficial effect of short-term enzalutamide treatment of COVID-19 patients.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Positive COVID-19 test
- •Mild to severe symptoms of COVID-19
- •Hospitalization
- •WHO performance status 0-3
- •Age above or equal to 50 years
- •Can understand all the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
- •Estimated expected survival of 1 year (excluding symptoms due to COVID-19)
排除标准
- •Severe allergy to Enzalutamide
- •Pregnant or breast-feeding women
- •Need of immediate mechanical ventilation
- •Current medication includes enzalutamide treatment
- •Stroke or Transitory Ischemic attack in medical history
- •Treatment for HIV
- •Treatment with tamoxifen
- •Treatment with immunosuppressive agents
- •Severe immunosuppressive disease
- •Treatment with warfarin or NOAC (Non-vitamin K-antagonist anticoagulants)
- •Previous seizure in medical history
- •Other serious illness or medical condition
- •Unstable cardiovascular disease
研究组 & 干预措施
Enzalutamide+Standard of Care
Up to 5 days with 4x40 mg enzalutamide tablets orally once daily
干预措施: Enzalutamide Pill (Drug)
结局指标
主要结局
Time to improvement of disease
时间窗: Up to 30 days after inclusion
Time to discharge from hospital assessed by the 7-point ordinal scale
Time to worsening of disease
时间窗: Up to 30 days after inclusion
Clinical worsening to invasive mechanical ventilation or death as assessed by the 7-point ordinal scale
次要结局
- Adverse events(Up to 6 months)
- Duration of supplemental oxygen (days)(Up to 30 days)
- Admission to ICU(Up to 30 days and up to 6 months)
- Laboratory assessment of Hemoglobin concentration day 0, 2, 4 and 6(Up to 30 days)
- Virus load assessment day 0, 2, 4 and 6(UP to 7 days)
- Hospital stay (days)(Up to30 days and 6 months)
- Re-admission to hospital due to rebound COVID-19(Evaluated for 30 days and after 6 months)
- Mortality at 6 months(up to 30 days and up to 6 months respectively)
- Laboratory assessment of CRP concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of liver function day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of creatinine concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of D-dimer concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of platelets concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of IL-6 concentration day 0, 2, 4 and 6(Up to 30 days)
- Laboratory assessment of B- and T-lyphocytes concentration day 0, 2, 4 and 6(Up to 30 days)
- Pharmacokinetic interaction of enzalutamide with steroids(Up to 30 days)
研究者
Andreas Josefsson
Assistant Professor and Consultant Urologist
Region Västerbotten