A Single-center, Open, Single-arm Clinical Study on the Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infections
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Prevalence of novel coronavirus infection
研究概览
简要总结
Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers
详细描述
This is a single-center, open-ended, single-arm clinical study to evaluate the effectiveness of daily ursodeoxycholic acid plus routine protective measures for the prevention of novel coronavirus infection. The target sample size is 130 medical workers and each healthy volunteer will be followed weekly for nucleic acid/antigen testing or disease progression over an 8-week period for new crown infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 65 years old.
- •No restriction on gender.
- •Medical-related personnel (working hours >20 hours per week) serving during the COVID-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students
- •COVID-19 nucleic acid test negative within 48 hours
- •Sign the informed consent form
排除标准
- •Exhibit COVID-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste
- •Previous infection with novel coronavirus within 6 months
- •Previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs
- •Those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment
- •Pregnancy and lactation
- •Use of drugs with which ursodeoxycholic acid is contraindicated
- •Other reported health conditions that make participation in the study not in the best interest of the individual
研究组 & 干预措施
Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment
Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment
干预措施: Ursodeoxycholic acid (Drug)
结局指标
主要结局
Prevalence of novel coronavirus infection
时间窗: Receiving 4 weeks of continuous ursodeoxycholic acid
Prevalence of novel coronavirus infection in healthy volunteers receiving 4 weeks of continuous ursodeoxycholic acid plus conventional protection during the study period
次要结局
- The number of days that symptoms of a novel coronavirus infection,muscle aches persisted in the population infected with novel coronavirus(8 weeks)
- The proportion of people infected with novel coronavirus who turned severe(8 weeks)
- The rate of positive serological antibodies in the population of healthy volunteers(8 weeks)
- The incidence of adverse events(8 weeks)