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    COVID 19

    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 (6)


    Name (Synonyms) Correlation
    drug457 Biological: mRNA-1273: 50 mcg Wiki 0.58
    drug1325 Flu shot Wiki 0.58
    drug456 Biological: mRNA-1273: 100 mcg Wiki 0.58
    Name (Synonyms) Correlation
    drug1923 MR or M-M-R II ® vaccine Wiki 0.58
    drug367 BCG vaccine Wiki 0.29
    drug2490 Placebo Wiki 0.22

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D045169 Severe Acute Respiratory Syndrome NIH 0.24
    D018352 Coronavirus Infections NIH 0.18

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 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.

    NCT04659941
    Conditions
    1. COVID 19 Vaccine
    Interventions
    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 Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older

    This clinical study will assess the safety, reactogenicity, and immunogenicity of 2 dose levels of mRNA-1273 SARS-COV-2 vaccine in adults 18 years of age or older.

    NCT04405076
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: Biological: mRNA-1273: 50 mcg
    2. Other: Placebo
    3. Biological: Biological: mRNA-1273: 100 mcg

    Primary Outcomes

    Measure: Solicited local and systemic adverse reactions (ARs)

    Time: 7 days post-vaccination

    Measure: Unsolicited adverse events (AEs)

    Time: 28 days post-vaccination

    Measure: Medically-attended adverse events (MAAEs)

    Time: Month 0 through Month 13

    Measure: Serious adverse events (SAEs)

    Time: Month 0 through Month 13

    Measure: Change in the measure of clinical safety laboratory values in Cohort 2 from baseline

    Time: Through 1 month after last vaccination

    Measure: The number and percentage of participants with abnormalities in blood pressure, temperature, HR or respiratory rate will be assessed.

    Time: Through 1 year after last vaccination

    Measure: The number and percentage of participants with abnormalities in physical examinations will be assessed

    Time: Through 1 year after last vaccination

    Measure: Evaluate immunogenicity of mRNA-1273 by titer of SARS-CoV-2-specific binding antibody (bAb) measured by enzyme-linked immunosorbent assay (ELISA)

    Time: Through 1 year after the final dose

    Secondary Outcomes

    Measure: Titer of SARS-CoV-2-specific neutralizing antibody (nAb)

    Time: Through 1 year post last vaccination

    Description: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer either from below the limit of detection (LOD) or lower limit of quantification (LLOQ) to equal to or above LOD or LLOQ, or a 4-times higher titer in participants with pre-existing nAb titers.

    Measure: Seroconversion as measured by an increase of SARS-CoV-2-specific neutralizing antibody (nAb) titer

    Time: Through 1 year post last vaccination
    3 An International, Multi-site, Bayesian Platform Adaptive, Randomized, Placebo-controlled Trial Assessing the Effectiveness of Candidate Agents in Mitigating COVID-19 Disease in Healthcare Workers

    The objective of CROWN CORONATION is the prevention of symptomatic COVID-19 by using combinations of approved and safe repurposed interventions, with complementary mechanisms of action.

    NCT04333732
    Conditions
    1. COVID 19
    Interventions
    1. Drug: MR or M-M-R II ® vaccine
    2. Drug: Placebo

    Primary Outcomes

    Description: To determine the incidence of the trial intervention(s) in preventing laboratory test-confirmed, symptomatic COVID19 (i.e. any of the following: cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell, nausea, vomiting, or diarrhea), in healthcare workers with repeated exposures to SARS-CoV-2 by day 60 after enrollment.

    Measure: Symptomatic COVID-19

    Time: 60 days

    Secondary Outcomes

    Description: Severity of COVID-19 will be graded on a simplified version of the ordinal World Health Organization COVID-19 severity scale (WHO COVID-19 severity scale).

    Measure: Severity of COVID-19 over the study period

    Time: 60 days

    Description: SARS-CoV-2 infection (by serology) over up to 5 months of follow-up

    Measure: Effectiveness of preventing/reducing SARS-CoV-2 infection

    Time: 5 months

    No related HPO nodes (Using clinical trials)


    HPO

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


    No related HPO nodes (Using clinical trials)


    Reports

    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.

    Drug Reports   MeSH Reports   HPO Reports  

    Interventions

    4,818 reports on interventions/drugs

    MeSH

    706 reports on MeSH terms

    HPO

    306 reports on HPO terms

    All Terms

    Alphabetical index of all Terms

    Google Colab

    Python example via Google Colab Notebook