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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
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drug2495 | Placebo (Normal saline solution) Wiki | 1.00 |
drug1148 | Edoxaban Tablets Wiki | 0.58 |
drug2645 | Probiotics Wiki | 0.58 |
Name (Synonyms) | Correlation | |
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D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
D018352 | Coronavirus Infections NIH | 0.04 |
D011014 | Pneumonia NIH | 0.03 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 3 clinical trials
Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.
Description: A patient will be considered a clinical failure if on Day 28 the patient is dead, intubated and/or in ICU.
Measure: Clinical failure at Day 28 Time: Day 28Description: Clinical improvement is defined as a decrease of at least two points on the WHO ordinal scale from the Day 1 visit to the Day 28 visit.
Measure: Clinical Improvement, defined as a decrease of at least 2 points on the World Health Organization (WHO) ordinal scale Time: Day 28Description: Overall survival (OS), defined as the time from randomization to the date of death due to any cause, will be analysed by means of Kaplan-Meier methodology.
Measure: Rate of overall survival (OS) at Day 28 and Day 60 Time: Day 28, Day 60Description: The incidence of AEs will be tabulated by MedDRA System Organ Class and Preferred Term. The incidence of AEs will also be summarised by System Organ Class, Preferred Term, and severity (based on NCI CTCAE v5.0 grades)
Measure: Incidence and severity of adverse events according to NCI CTCAE v5.0 Time: Day 60To explore the efficacy and confirm the safety of the concomitant administration of the standard of care and hzVSF-v13 in patients with COVID-19 infection
Description: Descriptive statistics for the changes from baseline in the clinical improvement score on an 8-point scale at Day 21 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Measure: Changes from baseline in the clinical improvement score on an 8-point scale at Day 21 Time: Day 21Description: Descriptive statistics for the changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon ranksum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Measure: Changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28 Time: Day 7, Day 14, Day 28Description: The Kaplan-Meier curves for the time to discontinuation of oxygen therapy after investigational product administration shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.
Measure: Time to discontinuation of oxygen therapy after investigational product administration Time: Day 28Description: *0 to 3 points in the clinical improvement score on an 8-point scale The Kaplan-Meier curves for the time to recovery after investigational product administration shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.
Measure: Time to recovery* after investigational product administration (days) Time: Day 28Description: Descriptive statistics for the changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Measure: Changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28 Time: Day 7, Day 14, Day 21, Day 28Description: Descriptive statistics for the changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Measure: Changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28 Time: Day 7, Day 14, Day 21, Day 28Description: The frequency and percentage for the proportion of subjects who died at Day 28 and Day 60 after investigational product administration shall be presented for each treatment group, and the Pearson's chi-squared test or the Fisher's exact test shall be performed to test differences of each study group compared to the control group.
Measure: Mortality at Day 28 and Day 60 after investigational product administration Time: Day 28, Day 60Explore the efficacy and confirm the safety of the concomitant administration of the standard of care and hzVSF-v13 in patients with COVID-19 infection
Description: The clinical failure rate is defined at Day 28 if patient reported any of Death Respiratory failure (patient is intubated) Patient is in the Intensive Care Unit (ICU)
Measure: Clinical failure rate at Day 28 Time: Day 28Description: Descriptive statistics for the changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon ranksum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Measure: Changes from baseline in the clinical improvement score on an 8-point scale at Day 7, Day 14, and Day 28 Time: Day 7, Day 14, Day 28Description: The Kaplan-Meier curves for the time to discontinuation of oxygen therapy after investigational product administration shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.
Measure: Time to discontinuation of oxygen therapy after investigational product administration Time: Day 28Description: * 0 to 3 points in the clinical improvement score on an 8-point scale The Kaplan-Meier curves for the time to recovery after investigational product administration shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.
Measure: Time to recovery* after investigational product administration (days) Time: Day 28Description: The Kaplan-Meier curves for the time to Clinical Improvement after randomization shall be presented, and the median time and 95% confidence interval will be presented by treatment group. In addition, a log-rank test shall be performed, if necessary, to test differences of each study group compared to the control group.
Measure: Time to Clinical Improvement from randomization to clinical improvement (2 points decreased from the baseline score) (days) Time: Day 28Description: Descriptive statistics for the changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Measure: Changes from baseline in PaO2/FiO2 at Day 7, Day 14, Day 21, and Day 28 Time: Day 7, Day 14, Day 21, and Day 28Description: Descriptive statistics for the changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28 shall be presented for each treatment group, and a two-sample t-test or the Wilcoxon rank-sum test shall be performed depending on whether the normality assumption is satisfied in order to test differences of each study group compared to the control group.
Measure: Changes from baseline in the NEWS 2 score at Day 7, Day 14, Day 21, and Day 28 Time: Day 7, Day 14, Day 21, Day 28Alphabetical 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