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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3 | (Standard of Care) SoC Wiki | 0.50 |
| drug412 | Aviptadil by intravenous infusion + standard of care Wiki | 0.50 |
| drug2618 | Normal Saline Infusion + standard of care Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.13 |
| D055371 | Acute Lung Injury NIH | 0.13 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.11 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 4 clinical trials
The aim of the study is to assess the safety, efficacy, and immunogenicity of AZD1222 for the prevention of COVID-19.
Description: A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs ≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case.
Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19 in adults ≥ 18 years of age Time: 1 yearDescription: Incidence of adverse events. Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.
Measure: The safety and tolerability of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age Time: a: 28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730.Description: Incidence of local and systemic solicited adverse events.
Measure: The reactogenicity of 2 IM doses of AZD1222 compared to placebo in adults ≥ 18 years of age (Substudy only) Time: 7 days post each dose of study intervention.Description: The proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time.
Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of SARS-CoV-2 infection Time: 1 yearDescription: The incidence of the first case of SARS-CoV-2 RT-PCR-positive symptomatic illness for a participant occurring at or after 15 days post second dose of study intervention using criteria from the CDC.
Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of symptomatic COVID-19 using CDC criteria Time: 1 yearDescription: The incidence of the first case of SARS-CoV-2 RT-PCR positive symptomatic illness occurring ≥ 15 days post second dose of study intervention using University of Oxford defined symptom criteria.
Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of University of Oxford defined symptomatic COVID-19 Time: 1 yearDescription: The incidence of SARS-CoV-RT-PCR-positive severe or critical symptomatic illness occurring 15 days or more post second dose of study intervention.
Measure: The efficacy of 2 IM doses of AZD12222 compared to placebo for the prevention of severe or critical symptomatic COVID-19. Time: 1 yearDescription: The incidence of COVID-19-related Emergency Department visits occurring ≥ 15 days post second dose of study intervention
Measure: The efficacy of 2 IM doses of AZD1222 compared to placebo for the prevention of COVID-19-related Emergency Department visits Time: 1 yearDescription: Post-treatment GMTs and GMFRs in SARS-CoV-2 S, RBD antibodies (MSD serology assay); The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to the S, RBD antigens of AZD1222 (MSD serology assay)
Measure: Antibody responses to AZD1222 S antigen following 2 IM doses of AZD1222 or placebo (Substudy and Illness Visits only) Time: 28 days post each doseDescription: Post-treatment GMTs and GMFRs in SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay); Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) to AZD1222 as measured by SARS-CoV-2 neutralizing antibodies (wild-type assay or pseudo-neutralization assay)
Measure: Anti-SARS-CoV-2 neutralizing antibody levels in serum following 2 IM doses of AZD1222 or placebo (Sub-study and Illness Visits only) Time: 28 days post each doseThe purpose of this study is to evaluate safety and immunogenicity of AZD1222 for COVID-19 prevention in the Russian Federation
Description: Occurrence of SAEs following the first vaccination and throughout the study duration (Day 180).
Measure: Incidence of SAEs following the first vaccination and throughout the study duration (Day 180) [Safety and Tolerability]. Time: 180 daysDescription: Local and systemic solicited AEs for 7 days following each vaccination. Unsolicited AEs for 28 days following each vaccination. Occurrence of AESIs following the first vaccination and throughout the study duration (Day 180).
Measure: Incidence of Solicited AEs for 7 following each vaccination [Safety and Tolerability]. Time: 180 daysDescription: immunogenicity / serologic responses to AZD1222
Measure: SARS-CoV-2 antigen-specific antibody levels Time: 180 daysDescription: immunogenicity / serologic responses to AZD1222
Measure: The rate of participants seroconverting from negative to positive SARS-CoV-2 S antigen Time: 180 daysDescription: immunogenicity / serologic responses to AZD1222
Measure: The rate of participants seroconverting from negative to positive SARS-CoV-2 N Time: 180 daysDescription: immunogenicity / serologic responses to AZD1222
Measure: Quantity of SARS-CoV-2 neutralizing antibodies Time: 180 daysDescription: immunogenicity / serologic responses to AZD1222
Measure: Count of peripheral blood mononuclear cells (PBMCs) Time: 180 daysDescription: immunogenicity / serologic responses to AZD1222
Measure: Quantity of seasonal coronavirus antigens Time: 180 daysDescription: immunogenicity / serologic responses to AZD1222
Measure: Quantity of antibodies to the ChAdOx1vector and the persistence of these antibodies over time Time: 180 daysThe COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.
Description: The primary immunogenicity endpoint is the proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to the Spike antigens of AZD1222 (MSD serology assay) at Day 29 (Part I) or Day 57 (Part II), and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (A, B, C, and D) and also Subcohorts B1, B2, D1, and D2 separately.
Measure: Proportion of participants who have a post treatment seroresponse Time: Day 29 or Day 57Description: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 1 to 8).
Measure: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination Time: Day 1 to 8Description: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 29 to 36).
Measure: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination Time: Day 29 to 36Description: The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 57.
Measure: The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) Time: Day 1 through Day 57Description: The change from baseline for blood chemistry measures (Creatinine in U/L ,Bilirubin in mg/dL, ALP in U/L, AST in U/L, ALT in U/L, Albumin in g/dL, Potassium in mEq/L, Calcium in mg/dL Sodium mEq/L, Creatine Kinase in U/L)
Measure: Biochemistry; change from baseline for blood chemistry measures Time: Day 8, Day 29, Day 36, and Day 57Description: The change from baseline for hematology measures (Hb in g/dL, Leukocyte in /uL, Leukocyte differential count in /uL and Platelet count in /uL)
Measure: Haematology; change from baseline for hematology/hemostasis measures Time: Day 8, Day 29, Day 36, and Day 57Description: Geometric mean titres (GMT) of immunogenicity to Spike antigen of AZD1222 (MSD serology assay) with its 95% CI will be computed at each time point in each treatment arm in each cohort (A, B, C, and D) and also in Subcohorts B1, B2, D1, and D2 separately.
Measure: Geometric mean titres Time: Day 29 or Day 57The COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. Currently, there are no licensed preventions available against COVID-19 and accelerated vaccine development is urgently needed. A safe and effective vaccine for COVID 19 prevention would have significant global public health impact.
Description: The primary immunogenicity endpoint is the proportion of participants who have a post treatment seroresponse (≥ 4-fold rise in titres from Day 1 baseline value) to the Spike antigens of AZD1222 (MSD serology assay) at Day 29 (Part I) or Day 57 (Part II), and will be calculated along with its 95% CI based on the Clopper-Pearson method in each treatment groups in each cohort (A, B, C, and D) and also Subcohorts B1, B2, D1, and D2 separately.
Measure: Proportion of participants who have a post treatment seroresponse Time: Day 29 or Day 57Description: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 1 to 8).
Measure: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination Time: Day 1 to 8Description: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination (Day 29 to 36).
Measure: The incidence of local and systemic solicited reactogenicity signs and symptoms for 7 days following throughout vaccination Time: Day 29 to 36Description: The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) collected from Day 1 through Day 57.
Measure: The incidence of AEs, serious adverse events (SAEs) and adverse events of special interest (AESIs) Time: Day 1 through Day 57Description: The change from baseline for blood chemistry measures (Creatinine in U/L ,Bilirubin in mg/dL, ALP in U/L, AST in U/L, ALT in U/L, Albumin in g/dL, Potassium in mEq/L, Calcium in mg/dL Sodium mEq/L, Creatine Kinase in U/L)
Measure: Biochemistry; change from baseline for blood chemistry measures Time: Day 8, Day 29, Day 36, and Day 57Description: The change from baseline for hematology measures (Hb in g/dL, Leukocyte in /uL, Leukocyte differential count in /uL and Platelet count in /uL)
Measure: Haematology; change from baseline for hematology/hemostasis measures Time: Day 8, Day 29, Day 36, and Day 57Description: Geometric mean titres (GMT) of immunogenicity to Spike antigen of AZD1222 (MSD serology assay) with its 95% CI will be computed at each time point in each treatment arm in each cohort (A, B, C, and D) and also in Subcohorts B1, B2, D1, and D2 separately.
Measure: Geometric mean titres Time: Day 29 or Day 57Alphabetical 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