NCT04453488Unknown3 期
Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of the RUTI® Vaccine to Prevent SARS-CoV-2 Infection
Fundació Institut Germans Trias i Pujol2 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30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 315
- 试验地点
- 2
- 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 RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers.
详细描述
The aim of this study is to assess the efficacy of RUTI® vaccine preventing SARS-CoV-2 infection (COVID-19) in healthcare workers. The study will include a comparison between placebo and RUTI® vaccine.
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.
- •Healthcare system workers working in contact with subjects potentially infected with SARS-CoV-
- •People ≥ 18 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
- •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 1year.
- •Soy allergy.
- •12 Chloroquine or hydroxychloroquine administration in the last two weeks.
- •13. Direct involvement in the design or execution of the RUTICOVID19 clinical trial.
- •14 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.
- •15. Employee at the health center <22 hours per week.
- •16. Do not have a smartphone.
- •17. Detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol.
- •18. 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
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)
RUTI® vaccine
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: Up to 4 months
% positive serology at the end of the study or positive PCR test in the course of routine clinical practice
次要结局
- Quarantine imposed by close contact outside the center with SARS-CoV-2 positive(Up to 4 months)
- Incidence of hospital admissions(Up to 4 months)
- Days of hospitalization(Up to 4 months)
- Fever(Up to 4 months)
- Professional category(Up to 4 months)
- Incidence of admissions to Intensive Care Unit (ICU)(Up to 4 months)
- Sick leave for SARS-CoV-2(Up to 4 months)
- Days off work due to the quarantine(Up to 4 months)
- Incidence of self-reported acute respiratory symptoms(Up to 4 months)
- Days of self-reported acute respiratory symptoms(Up to 4 months)
- Incidence of death from SARS-CoV-2 infection(Up to 4 months)
- Incidence of pneumonia(Up to 4 months)
- Days in ICU(Up to 4 months)
- Incidence of mechanical ventilation(Up to 4 months)
- Levels of SARS-CoV-2 antibodies(Final visit)
- Incidence of SARS-CoV-2 antibodies(Final visit)
- Types of antibodies detected(Final visit)
研究者
研究点 (2)
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