NCT04366180Unknown不适用
Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19
Biosearch S.A.2 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2020年4月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Incidence of SARS CoV-2 infection in healthcare workers
研究概览
简要总结
The aim of the present study is to evaluate the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of Covid-19 in health workers exposed to the virus. This is a preventive study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons over 20 years of age.
- •Active healthcare personnel, who attend patients with COVID-19 disease, including all professional categories, medicine, nursing and warders.
- •Ability to complete surveys.
- •Signature of informed consent
排除标准
- •Person with positive test of COVID-19 confirmed by PCR test or serology
- •Person with concomitant pathology HIV, transplant, active oncology or other type of active immunosuppression
- •Pregnant women or women with intention to become pregnant in the next 2 months.
结局指标
主要结局
Incidence of SARS CoV-2 infection in healthcare workers
时间窗: 8 weeks
The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test
次要结局
- Medical treatment(8 weeks)
- Days with body's temperature > 37.5 ºC(8 weeks)
- Days with fatigue(8 weeks)
- Incidence of hospital admissions caused by SARS-CoV-2 infection(8 weeks)
- Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection(8 weeks)
- Incidence of ICU admissions caused by SARS-CoV-2 infection(8 weeks)
- Incidence of pneumonia caused by SARS-CoV-2 infection(8 weeks)
- Incidence of oxygen support requirement caused by SARS-CoV-2 infection(8 weeks)
- Days with cough(8 weeks)
研究者
研究点 (2)
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