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Name (Synonyms) | Correlation | |
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drug2083 | NK Cells Wiki | 0.38 |
drug833 | Comprehensive treatment Wiki | 0.38 |
drug2728 | RT-PCR SARS-Cov2 Wiki | 0.38 |
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There are 7 clinical trials
The purpose of the study is to assess safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac ", a solution for intramuscular administration, with the participation of healthy volunteers Study objectives A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using single dose of each component (Stage 1). A safety and tolerability assessment of the drug "Gam-COVID-Vac ", solution for intramuscular administration, using prime-boost immunization according to the proposed scheme (Stage 2). Post-vaccination immunity assessment at different time points after vaccination by: - Determination of antigen-specific antibody titer in blood serum by ELISA by comparison with baseline values before the vaccine administration and at days 14, 21, 28, and 42 after vaccination (hereinafter, the countdown comes from the first time of the vaccine administration); - Determination of virus neutralizing antibody titer before and at days 14, 28, and 42 after vaccination; - Determination of antigen-specific cellular immunity (specific T-cell immunity) before the vaccine administration and at days 14 and 28 after vaccination.
Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measure: Changing ofantibody levels against the SARS-CoV-2 glycoprotein S in 42 days Time: at days 0,14, 21, 28, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: Changing of of virus neutralizing antibody titer Time: at days 0,14, 28, 42Description: Determination of antigen-specific cellular immunity (specific T-cell immunityin particular, IFN-gamma production or lymphoproliferation)
Measure: Changing of antigen-specific cellular immunity level Time: at days 0,14, 42Randomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Description: Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
Measure: percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose Time: through the whole study, an average of 180 daysDescription: Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19
Measure: the severity of the clinical course of COVID-19 Time: through the whole study, an average of 180 daysDescription: Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies
Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first doseDescription: Describe the strength of cell-mediated immune response induced by the use of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo
Measure: Changing of antigen-specific cellular immunity level Time: the drug administration day before injecting the first dose of the study drug/placebo and 28±2 days after the first doseDescription: Geometric mean virus-neutralizing antibodies titer
Measure: Changing of of virus neutralizing antibody titer Time: the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first doseDescription: Incidence of adverse events in trial subjects compared to placebo
Measure: Incidence of adverse events in trial subjects Time: through the whole study, an average of 180 daysDescription: Severity of adverse events in trial subjects compared to placebo
Measure: Severity of adverse events in trial subjects Time: through the whole study, an average of 180 daysDescription: Percentage of study subjects with antibodies to the N-protein of the SARS - CoV-2 virus that appeared after vaccination
Measure: estimation of the proportion of study subjects with antibodies to the N-protein of the virus SARS-CoV-2 Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first doseRandomized, double-blind (blinded for the trial subject and the study physician), placebo controlled, multi-center clinical trial in parallel assignment of efficacy, immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Description: Demonstrate the superiority of Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the second dose of the study drug/placebo, as confirmed with the method of polymerase chain reaction (PCR)
Measure: percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose Time: through the whole study, an average of 180 daysDescription: Assess the efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus compared to placebo, based on the severity of the clinical course of COVID-19
Measure: the severity of the clinical course of COVID-19 Time: through the whole study, an average of 180 daysDescription: Assess the immunogenicity of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection compared to placebo, based on the geometric mean titer of SARS-CoV-2 glycoprotein-specific antibodies
Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S Time: day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first doseDescription: Incidence of adverse events in trial subjects compared to placebo
Measure: Incidence of adverse events in trial subjects Time: through the whole study, an average of 180 daysDescription: Severity of adverse events in trial subjects compared to placebo
Measure: Severity of adverse events in trial subjects Time: through the whole study, an average of 180 daysThe purpose of this study: to assess the safety, tolerability and immunogenicity of the drug "Gam-COVID-Vac", a solution for intramuscular injection, at various times after vaccination in volunteers over 60 years of age
Description: Determination of antibody levels against the SARS-CoV-2 glycoprotein S measured by an ELISA vs. baseline values
Measure: Changing of antibody levels against the SARS-CoV-2 glycoprotein S in 42 days Time: at days 0, 21, 28, 42Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of virus neutralizing antibody titer
Measure: Changing of of virus neutralizing antibody titer Time: at days 0, 28, 42Description: Determination of antigen-specific cellular immunity
Measure: Changing of antigen-specific cellular immunity level Time: Time Frame: at days 0,28Randomized, 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.
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 doseDescription: 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 doseDescription: 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 doseDescription: 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 180Description: 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 180Description: Geometric mean virus-neutralizing antibodies titre in immunogenicity group
Measure: Immunogenicity assessment Time: Baseline, Day 21, Day 28, Day 42, Day 90, and Day 180Description: 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 180Description: 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 180Description: 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 180Description: 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 180Randomized, double-blind, placebo controlled clinical trial of immunogenicity, safety and efficacy of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults.
Description: Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Measure: Seroconversion rate Time: 42 day, 180 dayDescription: Incidence and severity of adverse events in trial subjects within 6 months after injecting the first dose of the study drug/placebo
Measure: Incidence and severity of adverse events Time: through the study (till day 180)Description: Geometric mean virus-neutralizing antibodies titer in 500 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 days after the first dose
Measure: Virus-neutralizing antibody levels against the SARS-CoV-2 Time: 42 dayDescription: Geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in 2,000 trial subjects on the drug administration day before injecting the first dose of the study drug/placebo and 42±2 and 180±14 days after the first dose
Measure: Antibody levels against the SARS-CoV-2 glycoprotein Time: 42 day, 180 dayDescription: Percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months, as confirmed with the method of polymerase chain reaction (PCR)
Measure: Percentage of trial subjects with coronavirus disease 2019 (COVID-19) Time: through the study (till day 180)This study is randomized, double-blind (blinded for the trial subject and the study physician), placebo-controlled trial in the parallel assignment of the immunogenicity, and safety of the Gam-COVID-Vac combined vector vaccine against the SARS-CoV-2-induced coronavirus infection in adults in the SARS-СoV-2 infection prophylactic treatment.
Description: The geometric mean titer of the SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 , 120±14 and 180±14 days after the first dose
Measure: SARS-CoV-2 glycoprotein-specific antibodies titer Time: 42±4 , 120±14 and 180±14 daysDescription: Percentage of trial subjects with fourfold or more increase in the titer of SARS-CoV-2 glycoprotein-specific antibodies in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4, 120±14 and 180±14 days after the first dose
Measure: Seroconversion rate Time: 42±4, 120±14 and 180±14 daysDescription: Interferon gamma concentration in response to S protein after re-stimulation with the SARS-CoV-2 glycoprotein in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose
Measure: IFN-gamma antigen-specific release Time: 28±4 daysDescription: The number of proliferating CD4 and CD8 cells in response to antigen stimulation in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 28±4 days after the first dose
Measure: CD4+/CD8+ proliferating cells Time: 28±4 daysDescription: Geometric mean virus-neutralizing antibodies titer in trial subjects on the drug administration day before injecting the first dose of the study vaccine/placebo and 42±4 and 120±14 days after the first dose
Measure: Virus-neutralizing antibodies titer Time: 42±4 and 120±14 daysDescription: Incidence and severity of adverse events in trial subjects within 4 & 6 months after injecting the first dose of the study vaccine/placebo.
Measure: Incidence and severity of adverse events Time: within 4 & 6 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
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