Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3440 | SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 2 Wiki | 1.00 |
| drug3439 | SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 Wiki | 1.00 |
| drug2625 | Normal saline solution (NSS), Placebo, Day 21 - Phase 1 Wiki | 1.00 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3438 | SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 Wiki | 1.00 |
| drug2624 | Normal saline solution (NSS), Placebo, Day 189 - Phase 2 Wiki | 1.00 |
| drug2626 | Normal saline solution (NSS), Placebo, Day 21 - Phase 2 Wiki | 1.00 |
| drug2623 | Normal saline solution (NSS), Placebo - Phase 2 Wiki | 1.00 |
| drug3435 | SARS-CoV-2 rS - Phase 1 Wiki | 1.00 |
| drug3437 | SARS-CoV-2 rS/Matrix-M Adjuvant - Day 189 - Phase 2 Wiki | 1.00 |
| drug3441 | SARS-CoV-2 rS/Matrix-M Adjuvant, Days 0 and 21 - Phase 2 Wiki | 1.00 |
| drug4168 | Usual Care Wiki | 0.33 |
| drug963 | Colchicine Wiki | 0.29 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D018352 | Coronavirus Infections NIH | 0.04 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial. Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2. Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at up to 40 sites across Australia and/or the United States.
Description: Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 21) by severity score, duration, and peak intensity.
Measure: Participants with Solicited Adverse Events (AEs) - Phase 1 Time: 28 daysDescription: Safety laboratory values (serum chemistry, hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
Measure: Safety Laboratory Values (Serum Chemistry, Hematology) - Phase 1 Time: 28 daysDescription: 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 35.
Measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) - Phase 1 Time: 35 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 35.
Measure: Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) - Phase 1 Time: 35 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 35. SCR is the proportion of participants with ≥4-fold rises in ELISA units.
Measure: Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) - Phase 1 Time: 35 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
Measure: Serum IgG Antibody Levels Expressed as GMTs - Phase 2 Time: Day 35Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
Measure: Serum IgG Antibody Levels Expressed as GMFRs - Phase 2 Time: Day 35Description: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥4-fold rises) for the two-dose regimens by dose at Day 35 regardless of baseline immune status and stratified by baseline immune status.
Measure: Serum IgG Antibody Levels Expressed as SCRs - Phase 2 Time: Day 35Description: Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0 and 21) by severity score, duration, and peak intensity. Unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all medically attended adverse events [MAAEs]) through the 35 days by Medical Dictionary for Regulatory Activities (MedDRA) classification, severity score, and relatedness.
Measure: Participants with Solicited Adverse Events (AEs) - Phase 2 Time: 28 daysDescription: Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all medically attended adverse events [MAAEs]) through the 35 days by Medical Dictionary of Regulatory Activities (MedDRA) classification, severity score, and relatedness.
Measure: Participants with Unsolicited AEs - Phase 2 Time: 35 daysDescription: Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) through the first 49 days by MedDRA classification, severity score, and relatedness.
Measure: Participants with Unsolicited AEs - Phase 1 Time: 49 daysDescription: Percentage of participants with vital sign abnormalities on the day of vaccination by severity scoring immediately following vaccination.
Measure: Participants with Abnormal Vital Signs - Phase 1 Time: 21 daysDescription: Mean changes from baseline in body temperature by treatment group and visit.
Measure: Changes from Baseline in Body Temperature - Phase 1 Time: 189 daysDescription: Mean changes from baseline in blood pressure by treatment group and visit.
Measure: Changes from Baseline in Blood Pressure - Phase 1 Time: 189 daysDescription: Mean changes from baseline in pulse rate by treatment group and visit.
Measure: Changes from Baseline in Pulse Rate - Phase 1 Time: 189 daysDescription: Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 105 by MedDRA classification, severity score, and relatedness.
Measure: Participants with MAAEs - Phase 1 Time: 105 daysDescription: Percentage of participants with MAAEs assessed as related to study vaccine, SAEs, and AESIs until the end of the study (EOS) by MedDRA classification and severity score. All SAEs and AESI, defined as potential immune-mediated medical conditions or AEs relevant to COVID-19, by MedDRA classification, severity score, and relatedness.
Measure: Participants with Related MAAEs; Serious Adverse Events (SAEs); and Adverse Events of Special Interest (AESI) - Phase 1 Time: 386 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at multiple time points through Day 189.
Measure: Assessment of Serum IgG Antibody Levels Expressed as GMTs at Multiple Time Points - Phase 1 Time: 189 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at multiple time points through Day 189.
Measure: Assessment of Serum IgG Antibody Levels Expressed as GMFRs at Multiple Time Points - Phase 1 Time: 189 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (proportion of participants with ≥2-fold and ≥4-fold rises in antibody levels) at multiple time points through Day 189.
Measure: Assessment of Serum IgG Antibody Levels Expressed as SCRs at Multiple Time Points - Phase 1 Time: 189 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SRRs (proportion of participants with rises in ELISA units exceeding the 95th percentile of placebo participants) at multiple time points through Day 189.
Measure: Assessment of Serum IgG Antibody Levels Expressed by Seroresponse Rates (SRRs) at Multiple Time Points - Phase 1 Time: 189 daysDescription: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at multiple time points through Day 189.
Measure: Angiotensin-Converting Enzyme 2 (ACE2) Receptor Binding Inhibition Assay Expressed as GMTs - Phase 1 Time: 189 daysDescription: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at multiple time points through Day 189.
Measure: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs - Phase 1 Time: 189 daysDescription: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs at multiple time points through Day 189.
Measure: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs - Phase 1 Time: 189 daysDescription: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SRRs at multiple time points through Day 189.
Measure: ACE2 Receptor Binding Inhibition Assay Expressed as SRRs - Phase 1 Time: 189 daysDescription: Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 49.
Measure: Neutralizing Antibody Activity Expressed as GMTs - Phase 1 Time: 49 daysDescription: Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 49.
Measure: Neutralizing Antibody Activity Expressed as GMFRs - Phase 1 Time: 49 daysDescription: Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 49.
Measure: Neutralizing Antibody Activity Expressed as SCRs - Phase 1 Time: 49 daysDescription: Neutralizing antibody activity as detected by MN expressed as SRRs at multiple time points through Day 49.
Measure: Neutralizing Antibody Activity Expressed as SRRs - Phase 1 Time: 49 daysDescription: 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 - Phase 1 Time: 28 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
Measure: Assessment of Serum IgG Antibody Levels Expressed as GMTs - Phase 2 Time: 35 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
Measure: Assessment of Serum IgG Antibody Levels Expressed as GMFRs - Phase 2 Time: 35 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥ 4-fold change) for the single-dose regimens compared to the two-dose regimens and to placebo through Day 35 regardless of baseline immune status and stratified by baseline immune status.
Measure: Assessment of Serum IgG Antibody Levels Expressed as SCRs (≥ 4-fold change) - Phase 2 Time: 35 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
Measure: Assessment of Serum IgG Antibody Levels Expressed as GMTs at Multiple Time Points - Phase 2 Time: 217 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
Measure: Assessment of Serum IgG Antibody Levels Expressed as GMFRs at Multiple Time Points - Phase 2 Time: 217 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs (≥ 4-fold change) at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo, stratified by baseline immune response.
Measure: Assessment of Serum IgG Antibody Levels Expressed as SCRs (≥ 4-fold change) at Multiple Time Points - Phase 2 Time: 217 daysDescription: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMTs at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo.
Measure: ACE2 Receptor Binding Inhibition Assay Expressed as GMTs - Phase 2 Time: 217 daysDescription: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as GMFRs at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo.
Measure: ACE2 Receptor Binding Inhibition Assay Expressed as GMFRs - Phase 2 Time: 217 daysDescription: Epitope-specific immune responses to the SARS-CoV-2 rS protein receptor binding as detected by ACE2 receptor binding inhibition assay expressed as SCRs (≥ 4-fold change) at multiple time points through Day 217 for the single-dose regimens compared to the two-dose regimens and to placebo.
Measure: ACE2 Receptor Binding Inhibition Assay Expressed as SCRs - Phase 2 Time: 217 daysDescription: Neutralizing antibody activity as detected by MN expressed as GMTs at Days 35 and 217 relative to baseline in a subset of subjects by absolute titers and change from baseline.
Measure: Neutralizing Antibody Activity Expressed as GMTs - Phase 2 Time: 217 daysDescription: Neutralizing antibody activity as detected by MN expressed as GMFRs at Days 35 and 217 relative to baseline in a subset of subjects by absolute titers and change from baseline.
Measure: Neutralizing Antibody Activity Expressed as GMFRs - Phase 2 Time: 217 daysDescription: Neutralizing antibody activity as detected by MN expressed as SCRs (≥ 4-fold change) at Days 35 and 217 relative to baseline in a subset of subjects by absolute titers and change from baseline.
Measure: Neutralizing Antibody Activity Expressed as SCRs (≥ 4-fold change) - Phase 2 Time: 217 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMTs at Days 189 and 217 for boosting assessment with either placebo or active boost.
Measure: Assessment of Serum IgG Antibody Levels Expressed as GMTs - Phase 2 Boost Time: 217 daysDescription: Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs at Days 189 and 217 for boosting assessment with either placebo or active boost.
Measure: Assessment of Serum IgG Antibody Levels Expressed as GMFRs - Phase 2 Boost Time: 217 daysDescription: All MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 217 by MedDRA classification, severity score, and relatedness.
Measure: Participants with MAAEs - Phase 2 Time: 217 daysDescription: Percentage of participants with MAAEs assessed as related to study vaccine, SAEs, and AESIs until the end of the study (EOS) by MedDRA classification and severity score. All SAEs and AESI, defined as potential immune-mediated medical conditions or AEs relevant to COVID-19, by MedDRA classification, severity score, and relatedness.
Measure: Participants with Related MAAEs; SAEs; and AESIs - Phase 2 Time: 357 daysDescription: Percentage of participants with vital sign abnormalities on the day of vaccination by severity scoring immediately following vaccination. Descriptive statistics (mean, standard deviation, change from baseline) by treatment group, by visit.
Measure: Participants with Abnormal Vital Signs - Phase 2 Time: 21 daysDescription: Mean changes from baseline in body temperature by treatment group and visit.
Measure: Changes from Baseline in Body Temperature - Phase 2 Time: 189 daysDescription: Mean changes from baseline in blood pressure by treatment group and visit.
Measure: Changes from Baseline in Blood Pressure - Phase 2 Time: 189 daysDescription: Mean changes from baseline in pulse rate by treatment group and visit.
Measure: Changes from Baseline in Pulse Rate - Phase 2 Time: 189 daysDescription: Percentage of participants with SARS-CoV-2 positivity as diagnosed by qualitative polymerase chain reaction (PCR) following COVID-19 symptoms assessment from Day 28 through 6 months with severity classification, overall and by age strata (18-59, 60-84 years).
Measure: Participants with SARS-CoV-2 Positivity - Phase 2 Time: 161 daysDescription: Assessment of SARS-CoV-2 by qualitative PCR based on routine screening by self- collection (nasal mid-turbinate or saliva) from Day 28 through 6 months without symptomatology to further describe epidemiologic evolution of the pandemic and potential effect of vaccination.
Measure: Assessment of SARS-CoV-2 by Qualitative PCR - Phase 2 Time: 161 daysDescription: Assessment of cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro PBMC stimulation (eg, ELISpot, cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
Measure: Assessment of Cell-Mediated (Th1/Th2) Pathways - Phase 2 Time: 28 daysAlphabetical 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