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    SARS

    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 (11)


    Name (Synonyms) Correlation
    drug677 CVnCoV 6 μg Wiki 0.58
    drug3562 V-SARS Wiki 0.58
    drug676 CVnCoV 12μg Wiki 0.58
    Name (Synonyms) Correlation
    drug2593 Pneumococcal vaccine Wiki 0.58
    drug1443 Hepatitis A vaccine Wiki 0.58
    drug675 CVnCoV 12 μg Wiki 0.58
    drug928 Covax-19™ Wiki 0.58
    drug678 CVnCoV Vaccine Wiki 0.41
    drug370 BCG-Denmark Wiki 0.33
    drug2985 Saline Wiki 0.26
    drug2490 Placebo Wiki 0.07

    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 Clinical Trial of COVID-19 Therapeutic Vaccine Formulated as an Oral Pill

    Safety and immunogenicity one-month study in healthy individuals administered once-daily pill of therapeutic vaccine made from heat-inactivated plasma from donors with COVID-19. Healthy, at least 20, volunteers will be monitored for signs of adverse events. Their PBMC will be collected at baseline and one month later to analyze which type of immune response vaccine has induced.

    NCT04380532
    Conditions
    1. Covid19
    Interventions
    1. Biological: V-SARS

    Primary Outcomes

    Description: Routine laboratory complete blood cell count at pre- and post-treatment periods by automated CBC counter Routine laboratory complete blood count Routine clinical laboratory CBC parameters at pre- and post-treatment periods

    Measure: Effect on CBC as per CTCAE v4.0

    Time: 15 Days

    Description: Routine clinical laboratory blood biochemistry parameters at pre- and post-treatment periods by automated biochemistry analyzer

    Measure: Effect on biochemistry parameters as per CTCAE v4.0

    Time: 15 Days

    Secondary Outcomes

    Description: Clinical well-being assessed by CTCAE v4.0

    Measure: Lack of adverse events as per CTCAE v4.0

    Time: 15 days
    2 A Phase 3, Randomized, Observer-Blinded, Placebo-Controlled Clinical Study Evaluating the Safety and Immunogenicity of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adult Health Care Workers in Mainz (Germany)

    This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of participants.

    NCT04674189
    Conditions
    1. Coronavirus
    2. Covid19
    3. SARS-CoV-2
    4. Severe Acute Respiratory Syndrome
    Interventions
    1. Biological: CVnCoV Vaccine
    2. Drug: Placebo
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Number of Participants with Medically-attended Adverse Events

    Time: Day 29 to Day 211

    Measure: Intensity of Medically-attended Adverse Events per Investigator's Assessment

    Time: Day 29 to Day 211

    Measure: Number of Participants with Medically-attended Adverse Events Considered Related to Trial Vaccine

    Time: Day 29 to Day 211

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs)

    Time: Day 29 to Day 393

    Measure: Intensity of Serious Adverse Events (SAEs) per Investigator's Assessment

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

    Time: Day 29 to Day 393

    Measure: Intensity of Adverse Events of Special Interest (AESIs) per Investigator's Assessment

    Time: Day 29 to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

    Time: Day 29 to Day 393

    Measure: Number of Participants with Death due to a Serious Adverse Event (SAE)

    Time: Day 29 to Day 393

    Measure: Number of Participants with Adverse Events (AEs) Leading to Vaccine Withdrawal or Study Disctontinuation

    Time: Day 29 to Day 393

    Measure: Number of Participants with Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events

    Time: 28 days after vaccination

    Measure: Intensity of Unsolicited Adverse Events per the Investigator's Assessment

    Time: 28 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

    Time: 28 days after vaccination

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike (S) Protein-Specific Antibody Levels in Serum

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA). Seroconversion is defined as detectable SARS-CoV-2 RBD of S protein antibodies in the serum of participants who tested seronegative on prior to vaccination on Day 1.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike (S) Protein Antibodies

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Secondary Outcomes

    Measure: Number of Participants that Contract COVID-19 of Any Severity

    Time: Day 1 to Day 393

    Measure: Number of Participants that Contract Mild, Moderate, Severe and Moderate to Severe COVID-19

    Time: Day 1 to Day 393

    Description: Seroconversion is defined as detectable SARS-CoV-2 N protein antibodies in the serum of subjects on Day 211 and/or Day 393 of the trial, who tested seronegative at prior to vaccination on Day 1 and Day 43.

    Measure: Number of Participants Seroconverting to the Nucleocapsid (N) Protein of SARS-SoV-2

    Time: Day 1, 43, 211 and 393

    Measure: Burden of Disease (BoD) Score Based on First Episodes of Virologically-confirmed Cases of COVID-19

    Time: Day 1 to Day 393

    Description: Measured by a virus neutralizing assay in a subset of participants.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: Measured by a virus neutralizing assay in a subset of participants.

    Measure: Number of Participants Seroconverting to SARS-CoV-2

    Time: Days 1, 29, 43, 57, 120, 211 and 393

    Description: Measured by a virus neutralizing assay in a subset of participants.

    Measure: Individual Serum Antibodies to Spike (S) Protein of SARS-CoV-2

    Time: Days 43, 57, 120, 211 and 393
    3 COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age

    This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.

    NCT04515147
    Conditions
    1. Coronavirus
    2. Covid19
    3. SARS-CoV-2
    4. Severe Acute Respiratory Syndrome
    Interventions
    1. Biological: CVnCoV 6 μg
    2. Biological: CVnCoV 12 μg
    3. Biological: Hepatitis A vaccine
    4. Biological: Pneumococcal vaccine
    5. Biological: CVnCoV 12μg
    MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

    Primary Outcomes

    Measure: Number of Participants with Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Local Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale

    Time: 7 days after vaccination

    Measure: Duration of Solicited Systemic Adverse Events

    Time: 7 days after vaccination

    Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine

    Time: 7 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events

    Time: 28 days after vaccination

    Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale

    Time: 28 days after vaccination

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine

    Time: 28 days after vaccination

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Serious Adverse Events (SAEs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs)

    Time: Baseline to Day 393

    Measure: Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine

    Time: Baseline to Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Day 43

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: Day 43

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: Day 29

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Day 43

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: Day 29

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: Day 43

    Secondary Outcomes

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Solicited Local Adverse Events Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Duration of Solicited Local Adverse Events Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Solicited Systemic Adverse Events Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Duration of Solicited Systemic Adverse Events Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine

    Time: 7 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Unsolicited Adverse Events Following the Booster Vaccine

    Time: 28 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Intensity of Unsolicited Adverse Events per the FDA Toxicity Grading Scale Following the Booster Vaccine

    Time: 28 days after booster vaccination

    Description: During Part 1, booster vaccinations will be administered to participants in Group 3 and a sub-group of participants in Group 4.

    Measure: Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine Following the Booster Vaccine

    Time: 28 days after booster vaccination

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Spike Protein Antibodies

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Individual SARS-CoV-2 Spike Protein-Specific Antibody Levels in Serum

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using Enzyme-Linked Immunosorbent Assay (ELISA).

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Spike Protein Antibodies

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using an activity assay.

    Measure: Number of Participants Seroconverting for SARS-CoV-2 Neutralizing Antibodies

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using an activity assay.

    Measure: Individual SARS-CoV-2 Neutralizing Antibody Levels in Serum

    Time: Day 57, Day 85, Day 180, Day 208 and Day 393

    Description: Measured using an activity assay.

    Measure: Geometric Mean Titers (GMTs) of Serum SARS-CoV-2 Neutralizing Antibodies

    Time: Day 57, Day 85, Day 180, Day 208 and 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

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