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    Sputnik

    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 (3)


    Name (Synonyms) Correlation
    drug1367 Gam-COVID-Vac Lyo Wiki 1.00
    drug1366 Gam-COVID-Vac Wiki 0.38
    drug2490 Placebo Wiki 0.13

    Correlated MeSH Terms (1)


    Name (Synonyms) Correlation
    D007239 Infection NIH 0.24

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects

    Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Phase II/III Adaptive Clinical Trial to Assess the Safety and Immunogenicity of Gam-COVID-Vac Combined Vector Vaccine for SARS-Сov-2 Infection in Indian Healthy Subjects.

    NCT04640233
    Conditions
    1. COVID-19 Prevention
    Interventions
    1. Biological: Gam-COVID-Vac
    2. Other: Placebo
    MeSH:Infection

    Primary Outcomes

    Description: For Phase II study - - Incidence & severity of adverse events (AEs) after first dose of IMP/Placebo For Phase III study - - Incidence of related serious adverse events (SAEs) following vaccination during the study

    Measure: Adverse Events

    Time: For Phase II study - at Day 28; For Phase III study - till day 180 after first dose

    Description: For Phase II study - - Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group

    Measure: Immunogenicity

    Time: For Phase II study - Day 28 after first dose

    Description: For Phase III study - Geometric mean titre ratio of SARS-CoV-2 glycoprotein-specific antibodies between IMP and placebo in immunogenicity group

    Measure: Immunogenicity

    Time: For Phase III study - Day 42 after first dose

    Secondary Outcomes

    Description: Incidence and severity of adverse events after injecting the first dose of the IMP/placebo Incidence of SAE following vaccination

    Measure: Adverse Events

    Time: Baseline to Day 180

    Description: Seroconversion rate of SARS-CoV-2 glycoprotein-specific antibodies in immunogenicity group Seroconversion rate of SARS-CoV-2 virus-neutralizing antibodies in immunogenicity group

    Measure: Immunogenicity assessment

    Time: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180

    Description: Geometric mean virus-neutralizing antibodies titre in immunogenicity group

    Measure: Immunogenicity assessment

    Time: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180

    Description: Interferon gamma concentration in T-cells after restimulation with the SARS-CoV-2 glycoprotein in cell mediated immunogenicity group

    Measure: Immunogenicity assessment

    Time: Baseline, Day 28, Day 42, Day 90 and Day 180

    Description: The number of proliferating cluster of differentiation 4 (CD4) cell and cluster of differentiation 8 (CD8) cells in response to mitogen stimulation in cell mediated immunogenicity group

    Measure: Immunogenicity assessment

    Time: Baseline, Day 28, Day 42, Day 90 and Day 180

    Description: Comparing percentage of subjects developing COVID-19 disease between Gam-COVID-Vac combined vector vaccine and placebo based on severity course

    Measure: Percentage of subjects with mild, moderate, severe coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose of the vaccine/placebo

    Time: Baseline to Day 180

    Description: Comparing incidence of COVID-19 disease between Gam-COVID-Vac combined vector vaccine and placebo

    Measure: Incidence of coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose in trial subjects

    Time: Baseline to Day 180

    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