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    Healthy

    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 (4)


    Name (Synonyms) Correlation
    drug899 Convalescent plasma Wiki 0.71
    drug1592 INO-4800 Wiki 0.58
    drug557 CELLECTRA® 2000 Wiki 0.50
    Name (Synonyms) Correlation
    drug2490 Placebo Wiki 0.13

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D045169 Severe Acute Respiratory Syndrome NIH 0.20
    D018352 Coronavirus Infections NIH 0.16

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure

    This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent COVID-19 disease in participants at high risk of exposure to SARS-CoV-2. The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 6178 participants.

    NCT04642638
    Conditions
    1. Coronavirus Infection
    2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
    3. COVID-19 Disease
    Interventions
    1. Drug: INO-4800
    2. Device: CELLECTRA® 2000
    3. Drug: Placebo
    4. Device: CELLECTRA® 2000
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay

    Time: Baseline up to Day 393

    Measure: Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay

    Time: Baseline up to Day 393

    Measure: Phase 3: Percentage of Participants With Virologically-confirmed COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Secondary Outcomes

    Measure: Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Injection Site Reactions

    Time: From time of consent up to 28 days post-dose 2 (up to Day 56)

    Measure: Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Systemic Adverse Events (AEs)

    Time: From time of consent up to 28 days post-dose 2 (up to Day 56)

    Measure: Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs)

    Time: Baseline up to Day 393

    Measure: Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Time: Baseline up to Day 393

    Measure: Phase 3: Percentage of Participants With Death From All Causes

    Time: Baseline up to Day 393

    Measure: Phase 3: Percentage of Participants With Non-Severe COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Percentage of Participants With Severe COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Percentage of Participants With Death From COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infections

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Days to Symptom Resolution in Participants With COVID-19 Disease

    Time: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393)

    Measure: Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay

    Time: Baseline up to Day 393

    Measure: Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay

    Time: Baseline up to Day 393

    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