COMBO Trial: Camostat With Bicalutamide for COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Participants Requiring Hospitalization
研究概览
简要总结
This will be a randomized, open-label study to determine if camostat+ bicalutamide decreases the proportion of people with COVID-19 who require hospitalization, compared to historical controls. Patients with symptomatic COVID-19, diagnosed as outpatients, will be randomized 1:1, stratified by gender, to treatment with standard of care alone (Arm 1) or with camostat and bicalutamide (Arm 2).
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 60 years of age
- •COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=5 days from enrollment done in the ambulatory setting
- •Able to provide informed consent
- •Symptom related to COVID-
- •This includes: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea or other symptom recognized by the Centers for Disease Control to be a symptom of COVID-19.
排除标准
- •Patients who undergo asymptomatic screening test that is positive and remain asymptomatic during the eligible time window
- •Patients who have had one or more positive more than 5 days prior to enrollment but within 60 days of enrollment (ex. if a patient has a positive test 10 days prior to enrollment and then a second positive test the day referred for enrollment, that patient would be excluded. If a patient had a positive test 5 months ago, and then another positive test the day he/she was referred for enrollment, that patient would be eligible)
- •Unable to take oral medication
- •Male patients with female partners of reproductive potential who are unable to maintain effective contraception during the recommended time period (during treatment and for 130 days after the final dose)
- •Symptoms requiring hospitalization or immediate referral to hospital
- •Taking bicalutamide, any systemic hormonal therapy, or camostat within one month of study entry
- •Known hypersensitivity to bicalutamide, or camostat, or its components.
- •On coumadin anticoagulation (because of drug-drug interaction with bicalutamide)
- •Self-reported past medical history of chronic liver disease or cirrhosis
- •Self-reported myocardial infarction within 6 months or past medical history of congestive heart failure with known ejection fraction < 40%
- •Taking any other investigational treatment for COVID-19 or COVID-19 prophylaxis (COVID-19 vaccines and treatments allowed under FDA Emergency Use Authorization are allowed.)
- •Women and people from all ethnic and race groups are eligible for this study.
研究组 & 干预措施
SOC plus camostat
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat for 7 days.
干预措施: Camostat Mesilate (Drug)
SOC plus camostat and bicalutamide
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
干预措施: Camostat Mesilate (Drug)
SOC plus camostat and bicalutamide
SARS-CoV-2 positive participants will receive SOC therapy as well as camostat and bicalutamide for 7 days.
干预措施: Bicalutamide 150 mg (Drug)
结局指标
主要结局
Number of Participants Requiring Hospitalization
时间窗: up to 28 days
Number of outpatient participants diagnosed with COVID-19 who require hospitalization by day 28
次要结局
- All-cause Mortality(up to 60 days)
- Number of Drug-related Adverse Events(up to 60 days)
- Number of Participants Experiencing Symptoms(up to 21 days)
- Number of Drug-related Serious Adverse Events(up to 60 days)