Randomized Trial of Bicalutamide to Block TMPRSS2 in Males With COVID-19 Infection
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Proportion x 100 = percent of patients with improved COVID-19 symptoms
研究概览
简要总结
COVID-19 outcomes are worse in male patients. Androgen signaling, therefore, is a target for clinical exploration. TMPRSS2 is a membrane protease required for COVID pathogenesis that is regulated by androgens. Blocking TMPRSS2 with bicalutamide may reduce viral replication and improve the clinical outcome. Therefore, the study proposes to test bicalutamide at 150 mg oral daily dosing in a double-blind placebo-controlled randomized trial in male patients with early symptomatic COVID-19 disease.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be eligible for study participation:
- •Men ≥ 36 years old diagnosed with at least one temperature elevation ≥ 100.4 F., OR new cough, OR new dyspnea AND documented COVID-19 positive by approved standard local laboratory assay
- •Men ≥ 18 years but < 36 years old must exhibit EITHER new cough, OR new dyspnea AND documented COVID-19 positive by approved standard local laboratory assay.
- •Access to working telephone or other form of communication such as email.
- •Randomization within 7 days of COVID-positive study result. All subjects will undergo repeat COVID-19 assay on day 0 enrollment and a positive test is required to stay on study
- •Written informed consent obtained from the subject and the subject agrees to comply with all study-related procedures
排除标准
- •Subjects with any of the following will not be eligible for study participation:
- •Randomization greater than 7 days from a positive COVID test result. All subjects will undergo repeat COVID-19 assay on day 0 enrollment and a negative test will result in a screen-fail and removal from study
- •Admission to hospital at time of screening
- •Inclusion in another randomized trial for COVID therapy
- •Diagnosis of prostate cancer and/or treatment with anti-androgen in the past 3 months
- •Current treatment with any androgen replacement products
- •Prior allergic reaction or intolerance to Bicalutamide or other Androgen receptor Inhibitors
- •Requirement for coumarin product or warfarin products due to potential displacement by bicalutamide
- •Subject unable to take oral bicalutamide
- •Known Hepatitis B or C
- •Liver Cirrhosis
- •AST/ALT greater than or equal to 3 X institutional ULN
研究组 & 干预措施
Standard of care and Experimental treatment of Bicalutamide
Each subject will be administered bicalutamide 150 mg daily at 1:1 randomization for up to 4 weeks.
干预措施: Bicalutamide 150 Mg Oral Tablet (Drug)
Standard of Care and Placebo
Each subject will be administered placebo as formulated at 1:1 randomization for up to 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion x 100 = percent of patients with improved COVID-19 symptoms
时间窗: Day 28
COVID-19 symptom relief at day 28, and % of COVID-19 symptom relief and its 95% confidence interval (CI) will be calculated using the exact binomial distribution and compared using Fisher's exact test.
次要结局
未报告次要终点