A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Percentage of participants who have clinical improvement at day 7 after randomization
研究概览
简要总结
Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=3 days from enrollment
- •Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms
- •Able to provide informed consent
排除标准
- •Unable to take oral medication
- •Pregnant or breastfeeding
- •On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
- •Requiring ≥6L oxygen or respiratory rate ≥30
- •Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry
- •Known hypersensitivity to bicalutamide or its components.
- •A past medical history of cirrhosis or AST/ALT/Alk phos/bilirubin > 3x the upper limit of normal
- •Patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction < 40%
- •Patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.
研究组 & 干预措施
Standard of care and bicalutamide
Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care
干预措施: Bicalutamide 150 Mg Oral Tablet (Drug)
结局指标
主要结局
Percentage of participants who have clinical improvement at day 7 after randomization
时间窗: up to 7 days
Percentage of participants who are discharged from the hospital or if they have had at least a 2-point improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. The WHO clinical improvement scale has a score range of 0-8 where, 0= uninfected, 1= ambulatory with no limitation of activities; 2= ambulatory with limitations to activities; 3= hospitalized, mild disease, with no oxygen therapy; 4= hospitalized, mild disease, with oxygen by mask or nasal prongs; 5= hospitalized, severe disease, with non-invasive ventilation or high-flow oxygen; 6= hospitalized, severe disease, with intubation and mechanical ventilation; 7= hospitalized, severe disease, with ventilation and additional organ support (pressors, dialysis, ECMO); 8= death
次要结局
- All-cause mortality(28 days)
- Duration of mechanical ventilation(up to 60 days)
- Percentage of patients needing upgrade to the intensive care unit (ICU)(up to 60 days)
- Duration of IMC stay(up to 60 days)
- Duration of hospitalization(up to 60 days)
- Number of participants experiencing adverse events(up to 60 days)
- Percentage of patients needing upgrade to the intermediate care unit (IMC)(up to 60 days)
- Duration of ICU stay(up to 60 days)
- Number of participants requiring mechanical ventilation(up to 60 days)