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    SARS (Severe Acute Respiratory Syndrome)

    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
    drug623 COVID-19 convalescent plasma Wiki 1.00
    drug385 BNT162b2 Wiki 0.50
    drug2490 Placebo Wiki 0.13

    Correlated MeSH Terms (1)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.16

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study

    This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant will last for approximately 13 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM) separated by 21 days.

    NCT04649021
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: BNT162b2
    2. Other: Placebo

    Primary Outcomes

    Description: SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)

    Time: 1 Month after Dose 2

    Measure: The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2

    Time: 1 Month after Dose 2

    Secondary Outcomes

    Description: Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - SCR

    Time: 1 Week, 6 and 12 Months after Dose 2

    Description: GMT of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing titers - GMT

    Time: 1 Week, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: GMT of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 IgG antibody level - GMT

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, the GMFR of SARS-CoV-2 serum neutralizing antibody titers at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR)

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: Compared with baseline before Vaccination 1, GMFR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measure: SARS-CoV-2 anti-S1 IgG antibody level - GMFR

    Time: 1 Week, 1, 6 and 12 Months after Dose 2

    Description: Pain at the injection site, redness, and swelling as self-reported on diary cards.

    Measure: Percentage of participants reporting local reactions

    Time: Within 7 Days and 14 Days after each vaccination

    Description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on diary cards.

    Measure: Percentage of participants reporting systemic events

    Time: Within 7 Days and 14 Days after each vaccination

    Description: Percentage of participants with abnormal hematology laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.

    Measure: Hematology laboratory assessments

    Time: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2

    Description: Percentage of participants with abnormal chemistry laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.

    Measure: Chemistry laboratory assessments

    Time: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2

    Description: Percentage of participants with grading shifts in hematology laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.

    Measure: Hematology laboratory assessments

    Time: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2

    Description: Percentage of participants with grading shifts in chemistry laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.

    Measure: Chemistry laboratory assessments

    Time: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2

    Description: AEs from dose 1 to 1 month after the last dose.

    Measure: Adverse events (AEs)

    Time: From Dose 1 through 1 Month after the last Dose

    Description: SAEs from dose 1 to 6 months after the last dose.

    Measure: Serious AEs (SAEs)

    Time: From Dose 1 through 6 Months after the last Dose

    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