The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bioithas SL
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Cases with discharge to ICU.
研究概览
简要总结
A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.
详细描述
In this study, the investigators hypothesize a positive effect of probiotic on the gut microbiome that could led to produce a less severe clinical evolution of the 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
- None
盲法说明
Random numbers table. One branch placebo and other one no intervention
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
- •Patients with a confirmed diagnosis of SARS-Cov.2 infection using the PCR and that require admission to the hospitalization area.
排除标准
- •Inability or refusal to sign informed consent.
- •Allergy or intolerance to the intervention product or its components.
结局指标
主要结局
Cases with discharge to ICU.
时间窗: 30-days
Percentage of patients with discharge to ICU.
Patients with resolution of digestive symptoms
时间窗: 30 days
Percentage of patients with improvement between the initial and final visits
次要结局
- Patients with resolution of non-digestive symptoms(30 days)
- Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.(10-15 days)
- New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.(30-days)
- Mortality.(30-days)
- Treatment safety assessed by number of adverse events.(30-days)
- Patients with home discharge.(30-days)