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    Coronavirus infection

    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 (14)


    Name (Synonyms) Correlation
    drug840 Comparable Placebo of drug Wiki 0.58
    drug454 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Wiki 0.58
    drug2108 NA-831 Wiki 0.58
    Name (Synonyms) Correlation
    drug386 BNT162b3 Wiki 0.58
    drug452 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki 0.58
    drug453 Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki 0.58
    drug829 Combination of oral polio vaccine and NA-831 Wiki 0.58
    drug458 Biological: oral polio vaccine Wiki 0.58
    drug839 Comparable Placebo of Oral Polio Vaccine and Placebo of drug Wiki 0.58
    drug838 Comparable Placebo Wiki 0.58
    drug623 COVID-19 convalescent plasma Wiki 0.58
    drug384 BNT162b1 Wiki 0.33
    drug385 BNT162b2 Wiki 0.29
    drug2490 Placebo Wiki 0.15

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D018352 Coronavirus Infections NIH 0.28
    D045169 Severe Acute Respiratory Syndrome NIH 0.12

    Correlated HPO Terms (0)


    Name (Synonyms) Correlation

    Clinical Trials

    Navigate: Correlations   HPO

    There are 3 clinical trials


    1 A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy Adults

    This trial has two parts. Part A, a dose finding part, with three dose escalation cohorts, one dose de-escalation cohort, three dose refinement cohorts, and up to three optional cohorts in older subjects. Part B, a part with expansion cohorts with dose levels which are selected using data generated in Part A. The vaccine BNT162b3 will be administered using a Prime/Boost (P/B) regimen.

    NCT04537949
    Conditions
    1. Covid-19
    2. Protection Against COVID-19
    Interventions
    1. Biological: BNT162b3

    Primary Outcomes

    Measure: Solicited local reactions at the injection site (pain/tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.

    Time: up to 7 days following each dose administration

    Measure: The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE) occurring up to 21±2 days after the prime immunization.

    Time: 21 days following dose administration

    Measure: The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the boost immunization.

    Time: 28 days following dose administration

    Secondary Outcomes

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Functional antibody responses.

    Time: up to 365 days following dose administration

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Fold increase in functional antibody titers.

    Time: up to 365 days following dose administration

    Description: At 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, 162±7 days, and 365±14 days after the boost immunization.

    Measure: Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline.

    Time: up to 365 days following dose administration
    2 Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study

    This is a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy population. After randomization, the trial for each subject will last for approximately 12 months. Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and each dose of either SARS-CoV-2 vaccine (BNT162b1) or placebo will be given intramuscularly (IM).

    NCT04523571
    Conditions
    1. SARS-CoV-2
    Interventions
    1. Biological: BNT162b1
    2. Other: Placebo

    Primary Outcomes

    Measure: Occurrence of solicited local reactions in the subjects (e.g., vaccination sites: pain/tenderness, erythema/redness, induration/swelling) during the 14-days after each dose of BNT162b1 or placebo.

    Time: 14 days following each dose administration

    Measure: Occurrence of solicited systematic reactions (e.g., nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) during 14-day after each dose of BNT162b1 or placebo.

    Time: 14 days following each dose administration

    Measure: Occurrence of adverse event (AE) associated with vaccination in subjects during the 21-day period after prime vaccination of BNT162b1 or placebo.

    Time: 21-day period after prime vaccination

    Measure: Occurrence of AE associated with vaccination in subjects during the 28-day period after boost dose of BNT162b1 or placebo.

    Time: 28-day period after boost dose

    Secondary Outcomes

    Measure: The proportion of subjects experiencing serious adverse events (SAEs), occurring up to Day 21 after prime vaccination and Day 28 after boost vaccination, up to Month 3, 6 and 12.

    Time: Day 21 after prime vaccination, Day 28 after boost vaccination, and Month 3, 6 and 12

    Measure: The proportion of subjects experiencing AE associated with BNT162b1, occurring up to Month 3, 6 and 12.

    Time: up to Month 3, 6 and 12

    Measure: The proportion of subjects experiencing abnormal markers of hematology, blood chemistry and urine analysis, occurring at Hour 24 and Day 7 after prime vaccination and Day 7 period after boost dose of BNT162b1 or placebo.

    Time: Hour 24 and Day 7 after prime vaccination and Day 7 after boost dose

    Measure: Geometric mean titer (GMT) of anti-S1 IgG antibody at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: GMT of anti-receptor binding domain (RBD) immunoglobulin G (IgG) antibody at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: GMT of SARS-CoV-2 neutralizing antibody (including true virus-based SARS-CoV-2 neutralizing test) at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: Fold increase in antibody anti-S1 IgG antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: Fold increase in antibody anti-RBD IgG antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: Fold increase in SARS-CoV-2 neutralizing antibody titers (virus neutralizing test), as compared to baseline, at Day 7, Day 21 after prime vaccination, at Day 7, Day 21 after boost vaccination, and at Month 3, 6 and 12.

    Time: Day 7, Day 21 after prime vaccination, Day 7, Day 21 after boost vaccination, and Month 3, 6 and 12

    Measure: Seroconversion rates (SCR) defined as a minimum of 4-fold increase of antibody titers, as compared to baseline, at Day 7, Day 21 after prime vaccination, and at Day 7, Day 21 after boost vaccination.

    Time: Day 7, Day 21 after prime vaccination, and Day 7, Day 21 after boost vaccination
    3 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

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    Python example via Google Colab Notebook