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临床试验/NCT04362124
NCT04362124撤回3 期

Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection in Medellín, Colombia, 2020

Universidad de Antioquia2 个研究点 分布在 1 个国家开始时间: 2020年8月最近更新:
适应症

试验速览

阶段
3 期
状态
撤回
试验地点
2
主要终点
Primary outcome

研究概览

简要总结

Until the first half of April, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases. Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view.

Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question may be that there are differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe. This finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses.

Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations, and currently there are no vaccines or proven preventive interventions available to protect them.

For this reason, this research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death.

In the future, and if these results are as expected, they may be the basis for undertaking a population vaccination campaign that improves clinical outcomes in the general population.

详细描述

Problem Statement

To date, Colombia has more than 2,800 infected cases and a hundred deaths as a result of COVID-19, with Antioquia being the third department with the highest number of cases (1). Official records indicate that, in Colombia, the first case was diagnosed on March 6, 2020, corresponding to a patient from Italy. However, in conversations with several infectologists and intensivists from Medellín, it was agreed that clinical cases similar to the clinical presentation that is now recognized as COVID-19 had arisen since the end of 2019 when it was still unknown to everyone. The previous suggests that the virus was already circulating in the country since before March 6, 2020. But at that moment, there were no tools to make a clinical identification, nor to diagnose it from the laboratory's point of view. This theory has been gathering momentum in other latitudes, demonstrating how the asymptomatic infected individuals are responsible for spreading the infection .

Considering as real the hypothesis that the infection has been circulating in the country since before the first official diagnosis, the question arises: Why does not the country still has the same healthcare and humanitarian chaos that countries such as Italy and Spain are suffering at this time? To answer this question, an extensive literature search of factors that differentiate Europeans from Latin Americans was carried out. Finding, in addition to genetic factors specific to race, differences in the number of ACEI receptors (binding site of the coronavirus to the alveolus), and differences in vaccination rates with BCG (Bacille Calmette-Guérin or tuberculosis vaccine), which is significantly higher in Latin America compared to those in Europe (3). This last finding could explain to some extent the situation in the country, since previous studies have shown the influence that this vaccine can have on the immune response against various other pathogens, including viruses (4,5).

Among the population at risk of infection, health-care workers due to their permanent contact with patients are the population group with the highest risk of contracting SARS-Cov-2 and developing COVID-19 in any of its clinical manifestations.

Currently, there are no vaccines or proven preventive interventions available to protect health-care workers. However, researchers from Germany, the Netherlands, Australia, and France are working on a clinical trial with an unorthodox approach to combat this new virus. This research study aims to demonstrate whether the centennial vaccine against tuberculosis (BCG), a bacterial disease, can activate the human immune system in a broad way, allowing it to better combat the coronavirus that causes COVID-19 and, perhaps, prevents the complications that lead the patient to the intensive care unit and death. Initially, studies in these four countries will be carried out on doctors and nurses, since they are the ones with a higher risk of becoming infected compared to the general population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Double-blind trial. The blinding of the investigational vaccine will be maintained using an opaque label for the two products (vaccine and placebo).

The subjects, who collect the data (e.g., investigator and coordinator) and who evaluate the data (e.g., statistician) will be blinded. One or more pharmacists/vaccine administrators designated from the facility will not be blinded. These designated unblinded individuals will maintain the blindness of the investigational vaccine and will not be involved in evaluating the safety of the subjects.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Primary outcome

时间窗: From date of randomization to 360 day of the study

Incidence of COVID-19 cases confirmed or probable in the study population

次要结局

  • Secondary outcome(At baseline evaluation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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