Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug899 | Convalescent plasma Wiki | 0.50 |
drug119 | AV-COVID-19 Wiki | 0.41 |
drug4004 | placebo Wiki | 0.41 |
Name (Synonyms) | Correlation | |
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D007239 | Infection NIH | 0.34 |
D003141 | Communicable Diseases NIH | 0.29 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.14 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 2 clinical trials
This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.
Description: Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.
Measure: Frequency of solicited local and systemic reactogenicity adverse events (AEs) Time: until follow up day 7Description: Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Measure: Safety Laboratory Values (Serum Chemistry) Time: until follow up day 7Description: Safety laboratory values (Hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Measure: Safety Laboratory Values (Hematology) Time: until follow up day 7Description: Percentage of participants with serious undesirable effect associated with the use of a medical product in a patient, which consist of death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), dan other serious important medical events
Measure: Frequency of any serious adverse events (SAEs) Time: until follow up day 365Description: NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination
Measure: Frequency of any new-onset chronic medical conditions (NOCMCs) Time: until follow up day 365Description: Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 365 by MedDRA classification, severity score, and relatedness.
Measure: Frequency of medically attended adverse events (MAAEs) Time: until follow up day 365Description: Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) or AESIs (potential immune-mediated medical conditions or AEs relevant to COVID-19) through the first 90 days by MedDRA classification, severity score, and relatedness.
Measure: Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs) Time: until follow up day 90Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 28.
Measure: Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) Time: until follow up day 28Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs through Day 28.
Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) Time: until follow up day 28Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 28. SCR is the proportion of participants with ≥4-fold rises in ELISA units.
Measure: Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) Time: until follow up day 28Description: Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 28.
Measure: Neutralizing Antibody Activity Expressed as GMTs Time: until follow up day 28Description: Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 28.
Measure: Neutralizing Antibody Activity Expressed as GMFRs Time: until follow up day 28Description: Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 28.
Measure: Neutralizing Antibody Activity Expressed as SCRs Time: until follow up day 28Description: Cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro peripheral blood mononuclear cell (PBMC) stimulation (eg, enzyme-linked immunospot [ELISpot], cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
Measure: Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways Time: until follow up day 28Description: Measurement of IgG in subject blood after one month
Measure: Optimal dose of SARS-CoV2 antigen and GM-CSF Time: until follow up month oneDescription: Measurement of IgG and neutralizing antibody in subject blood after 12 months
Measure: Duration of detection IgG and neutralizing antibody againts SARS-CoV-2in blood after vaccination Time: until follow up month 12This 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 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