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    BCG vaccine

    This report considers only clinical trials that are associated with COVID-19 vaccines.

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO

    Correlated Drug Terms (5)

    Name (Synonyms) Correlation
    drug369 BCG-10 vaccine Wiki 0.71
    drug16 0.9% saline Wiki 0.71
    drug367 BCG vaccine Wiki 0.35
    Name (Synonyms) Correlation
    drug128 AZD1222 Wiki 0.32
    drug2490 Placebo Wiki 0.09

    Correlated MeSH Terms (4)

    Name (Synonyms) Correlation
    D003141 Communicable Diseases NIH 0.29
    D045169 Severe Acute Respiratory Syndrome NIH 0.29
    D018352 Coronavirus Infections NIH 0.23
    Name (Synonyms) Correlation
    D007239 Infection NIH 0.17

    Correlated HPO Terms (0)

    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 2 clinical trials

    1 Use of BCG Vaccine as a Preventive Measure for COVID-19 in Health Care Workers

    The disease promoted by coronavirus (COVID-19) is caused by Severe Acute Respiratory Syndrome (SARS) caused by Coronavirus type 2 (CoV2), being the first cases identified in December 2019 in China after exposure to the animal market in Wuhan city, China. From the first case to the present day, the COVID-19 epidemic has been identified in 185 countries, with the notification of 2,666,154 cases and 186,144 deaths. In Brazil, more than 45,757 cases and 2,906 confirmed deaths by COVID-19 have been confirmed (Visualized on Apr 23 2020). In our country, to date, testing for COVID-19 occurs only in severe cases and few centers offer the service to health care workers, a population at high risk of infection. BCG is a vaccine produced from a live attenuated strain derived from a Mycobacterium bovis isolate and is widely used worldwide as a tuberculosis (TB) vaccine, but there are studies demonstrating non-specific immunotherapeutic mechanisms of this vaccine that signal a possible relationship with the lowest morbidity and mortality associated with COVID-19 infections worldwide. The present study aims to analyze the role of BCG in the prevention of SARS-CoV-2 infection and also in the occurrence of severe forms of COVID-19 in addition to evaluating the immune response mediated by this vaccine in voluntary health care workers.

    1. COVID 19 Vaccine
    1. Biological: BCG vaccine

    Primary Outcomes

    Description: It is estimated that it will take 500 individuals in each of the comparison groups to ensure a statistical power of 85% for the detection of a risk difference of 5%, considering that the control group will have an accumulated incidence of SARS-CoV-2 infection of 10% after 6 months of follow-up, for a type I error of 5%.

    Measure: Compare the cumulative incidence of SARS-CoV-2 infection

    Time: 12 months

    Description: With 500 individuals in each of the comparison groups the study will have a statistical power of approximately 75% for the detection of a risk difference of 2%, considering that the control group will have an accumulated incidence of more severe forms of COVID-19 of 2.5% after 6 months of follow-up, for a type I error of 5%.

    Measure: Compare the cumulative incidence of severe forms of COVID-19

    Time: 12 months

    Description: SARS-CoV2 infection is estimated to occur in approximately 10% of BCG-vaccinated healthcare professionals (experimental group) and in 30% of non-BCG-vaccinated healthcare professionals (placebo group) In this scenario, with the bearing of 500 health professionals in each arm, SARS-CoV2 infection is expected to be detected in 50 BCG-vaccinated professionals and 150 professionals not vaccinated with BCG. For each subgroup (vaccinated and not vaccinated with BCG) it will be possible to identify the predictive biomarkers of infection by comparing infected professionals with those who were not infected with SARS-CoV2.

    Measure: Assess the BCG vaccine-mediated immune response in health care workers

    Time: 12 months
    2 A Multi-centre, Randomised, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland

    Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes. The aim of the study is to answer the following questions: 1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)? 2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects? 3. Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result? A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking*. Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19. * to measure the level of cytokines involved in cell-mediated immunity process

    1. Covid19
    2. BCG Vaccination Reaction
    3. SARS-CoV Infection
    1. Drug: BCG-10 vaccine
    2. Drug: 0.9% saline
    MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Description: shock - when catecholamines are required despite initial fluid resuscitation severe respiratory failure - the need for non-invasive or invasive ventilation severe renal failure - the need for renal replacement therapy (for undialysed individuals, i.e. with end-stage renal failure (ESRD)

    Measure: death and life- or health-threatening condition (cardiac arrest with effective resuscitation, shock, severe respiratory failure, severe renal failure, stroke/transient cerebral ischaemia)

    Time: throughout the period of 18 months from inclusion

    Secondary Outcomes

    Description: Present symptoms (determined in the Telephone Contact Card) appear to indicate a possible SARS-CovV-2 infection

    Measure: Onset of clinical symptoms of COVID-19

    Time: 12 weeks from the date of the third visit - V3

    Description: based on anti SARS-CoV-2 IgG serological tests

    Measure: asymptomatic SARS-CovV-2 infection

    Time: 12 weeks from the date of the third visit - V3

    Description: the need for hospitalisation and its duration

    Measure: Hospitalisation

    Time: 12 weeks from the date of the third visit - V3

    Description: the need for hospitalisation in the ICU and its duration

    Measure: ICU Hospitalisation

    Time: 12 weeks from the date of the third visit - V3

    Description: requiring passive oxygen therapy to eliminate the symptom or maintain saturation >92%

    Measure: Dyspnoea

    Time: 12 weeks from the date of the third visit - V3

    No related HPO nodes (Using clinical trials)


    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials

    No related HPO nodes (Using clinical trials)


    Data processed on January 01, 2021.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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