Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1599 | GLS-1200 Wiki | 0.50 |
| drug1887 | IgG test Wiki | 0.50 |
| drug657 | Bromhexine Hydrochloride Wiki | 0.50 |
Navigate: Correlations HPO
There are 4 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 0,28Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 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