NCT04452773Unknown不适用
Double-blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of the Manremyc® Food Supplement to Prevent SARS-CoV-2 Infection
Reig Jofre Group10 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2020年7月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 315
- 试验地点
- 10
- 主要终点
- Documented cumulative incidence of SARS-CoV-2 infection
研究概览
简要总结
The purpose of this study is to assess the efficacy of Manremyc® food supplement for reduce the incidence of SARS-CoV-2 infection in a high risk population, as healthcare workers.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sign the Informed Consent before initiating the selection procedures.
- •Health system workers working in contact with subjects potentially infected with SARS-CoV-
- •People ≥ 18 years.
- •Availability to meet the requirements of the protocol.
- •Negative Rapid Serological Test of SARS-CoV-2
排除标准
- •Previous SARS-CoV-2 infection
- •Pregnancy or breastfeeding.
- •Suspected of active viral or bacterial infection.
- •Symptoms compatible with COVID-19, despite a negative PCR test.
- •Vaccination in the last 4 weeks or planned vaccination during the study period, regardless of the type of vaccine.
- •Participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the Consent or during the study.
- •Severely immunocompromised people. This exclusion category includes:
- •Subjects with human immunodeficiency virus (HIV-1).
- •Neutropenic subjects with less than 500 neutrophils / mm
- •Subjects with solid organ transplantation.
- •Subjects with bone marrow transplantation.
- •Subjects undergoing chemotherapy.
- •Subjects with primary immunodeficiency.
- •Severe lymphopenia with less than 400 lymphocytes / mm
- •Treatment with any anti-cytokine therapy.
- •Oral treatment with steroids, defined as daily doses of 10 mg prednisone or equivalent for more than 3 months.
- •Malignancy, or active solid or non-solid lymphoma from the previous two years.
- •BCG vaccination in the last 10 years.
- •Treatment with Manremyc® for the last 6 months.
- •Chloroquine or hydroxychloroquine administration in the last two weeks.
- •Direct involvement in the design or execution of the MANRECOVID19 clinical trial.
- •Retirement, transfer, long-term leave (> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study.
- •Employee at the health center <22 hours per week.
- •Do not have a smartphone.
- •Detection by the investigator of lack of knowledge or willingness to participate and comply with all requirements of the protocol.
- •Any other findings that, at the discretion of the investigator, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of probiotic.
结局指标
主要结局
Documented cumulative incidence of SARS-CoV-2 infection
时间窗: up to 4 months
% of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
次要结局
- Cumulative incidence of self-reported acute respiratory symptoms(up to 4 months)
- Number of days of self-reported acute respiratory symptoms(up to 4 months)
- Incidence of hospital admissions(Up to 4 months)
- Levels of IgG(Up to 4 months)
- Levels of SARS-CoV-2 antibodies at the end of the study period(Up to 4 months)
- Documented sick leave for SARS-CoV-2(up to 4 months (cumulative))
- days off work due to the quarantine(up to 4 months)
- Quarantine imposed by close contact outside the center with SARS-CoV-2 positive(up to 4 months)
- Fever(Up to 4 months)
- Incidence of pneumonia(up to 4 months)
- Cumulative incidence of death from documented SARS-CoV-2 infection(Up to 4 months)
- Incidence of admission to ICU(Up to 4 months)
- Days in IUC(Up to 4 months)
- Incidence of mechanical ventilation(Up to 4 months)
- Days of hospitalization(Up to 4 months)
- Levels of IgM(Up to 4 months)
研究者
研究点 (10)
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