NCT04903184已完成2 期
A Exploratory Phase II Clinical Trial, Double-blind, Randomized Placebo-controlled to Evaluate the Efficacy of RUTI® Against SARS-COV-2 Infection (COVID-19) in Healthcare Workers
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 6
- 主要终点
- Documented cumulative incidence of SARS-CoV-2 infection
研究概览
简要总结
The aim of this study is to explore potential for reduction of incidence and/or morbidity of SARS-CoV-2 infection in healthcare personnel. The study will include a comparison between placebo and RUTI® vaccine in a 2:1 design.
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.
- •Population:
- •Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-2
- •People between 18 years and 59 years
- •Willingness to meet the requirements of the protocol.
- •Negative Rapid Serological Test of SARS-CoV-2
- •The participant must agree to use effective contraceptive methods during the study period, in case of childbearing age.
排除标准
- •Previous SARS-CoV-2 infection
- •Pregnancy. Pregnancy test will be performed in case of doubt.
- •Breastfeeding.
- •Suspected of active viral or bacterial infection.
- •Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
- •Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza 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
- •Malignancy, or active solid or non-solid lymphoma from the previous two years.
- •Soy allergy.
- •Direct involvement in the design or execution of the RUTICOVID19 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.
- •Do not have a smartphone.
- •Detection by the researcher 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 researcher, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of the vaccine.
研究组 & 干预措施
Group Placebo
Placebo Comparator
Participants will receive two dose of physiological serum will be administered subcutaneously in the deltoid region at the baseline visit and after 2 weeks +/- 3 days.
干预措施: Placebo (Biological)
Group RUTI
Experimental
Participants will receive two dose of RUTI® vaccine at the baseline visit and after 2 weeks +/- 3 days, which will be administered subcutaneously in the deltoid region at a dose of 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli in an injection volume of 0.3 mL.
干预措施: RUTI® vaccine (Biological)
结局指标
主要结局
Documented cumulative incidence of SARS-CoV-2 infection
时间窗: 6 months
Percent of positive serology at the end of the study or positive PCR test in the course of routine clinical practice
次要结局
- Days of hospitalization(6 months)
- Incidence of SARS-CoV-2 antibodies(Study completion, an average of 1 year)
- Levels of SARS-CoV-2 antibodies(Study completion, an average of 1 year)
- Fever(6 months)
- Incidence of death from SARS-CoV-2 infection(6 months)
- Incidence of mechanical ventilation(6 months)
- Incidence of hospital admissions(6 months)
- Sick leave for SARS-CoV-2(6 months)
- Days off work due to the quarantine(6 months)
- Quarantine imposed by close contact outside the center with SARS-CoV-2 positive(6 months)
- Incidence of self-reported acute respiratory symptoms(6 months)
- Days in ICU(6 months)
- Types of antibodies detected(Study completion, an average of 1 year)
- Days of self-reported acute respiratory symptoms(6 months)
- Incidence of pneumonia(6 months)
- Incidence of admissions to Intensive Care Unit (ICU)(6 months)
研究者
研究点 (6)
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