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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3672 | Sofusa DoseConnect Wiki | 0.50 |
| drug687 | CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc Wiki | 0.50 |
| drug1381 | Enbrel Wiki | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000856 | Anorexia Nervosa NIH | 0.50 |
| D000855 | Anorexia NIH | 0.50 |
| D009369 | Neoplasms, NIH | 0.17 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002039 | Anorexia HPO | 0.50 |
| HP:0002664 | Neoplasm HPO | 0.17 |
| HP:0001370 | Rheumatoid arthritis HPO | 0.13 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001369 | Arthritis HPO | 0.11 |
Navigate: Correlations HPO
There are 4 clinical trials
This phase II trial studies the effect of baricitinib in combination with antiviral therapy for the treatment of patients with moderate or severe coronavirus disease-2019 (COVID-19). Treatment with antiviral medications such as hydroxychloroquine, lopinavir/ritonavir, and/or remdesivir may act against infection caused by the virus responsible for COVID-19. Baricitinib may reduce lung inflammation. Giving baricitinib in combination with antiviral therapy may reduce the risk of the disease from getting worse and may help prevent the need for being placed on a ventilator should the disease worsen compared to antiviral therapy alone.
Description: Descriptive statistics, including means, standard deviations, and ranges for continuous variables, as well as percentages and frequencies for categorical variables, will be provided to describe all the clinical findings in a cohort of symptomatic coronavirus disease 2019 (COVID-19)-infected subjects. The collected data will also be graphically presented in boxplots, histograms, and scatter plots. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity, will be made. Group comparisons will be made using either the parametric tests such as t-test and analysis of variance (ANOVA), or the non-parametric statistical method such as Wilcoxon and Kruskal-Wallis tests for continuous variable and Chi-square test for categorical variables. Point estimates, along with the corresponding p-values and 95% confidence intervals will be reported.
Measure: Proportion of patients requiring invasive mechanical ventilation or dying Time: Up to 14 daysDescription: Body temperature will be measured in degrees Fahrenheit using an automated thermometer.
Measure: Identification of clinical features (vitals signs - body temperature) Time: Up to 28 daysDescription: Respiratory rate in times/minute
Measure: Identification of clinical features (vital signs - respiratory rate) Time: Up to 28 daysDescription: Heart rate in beats/minute
Measure: Identification of clinical features (vital signs - heart rate) Time: Up to 28 daysDescription: Blood pressure in mmHg
Measure: Identification of clinical features (vital signs - blood pressure) Time: Up to 28 daysDescription: Chest X-ray or pulmonary computed tomography (CT) will be performed
Measure: Identification of clinical features (Imaging) Time: Up to 28 daysDescription: Assessment via standard blood chemistry and metabolic panel
Measure: Identification of clinical features (Lab - White Blood Count) Time: Up to 28 daysDescription: Assessment via standard blood chemistry and metabolic panel
Measure: Identification of clinical features (Lab - Absolute Lymphocyte Count) Time: Up to 28 daysDescription: Assessment via standard blood chemistry and metabolic panel
Measure: Identification of clinical features (Lab - Hemoglobin) Time: Up to 28 daysDescription: Assessment via standard blood chemistry and metabolic panel
Measure: Identification of clinical features (Lab - Creatinine) Time: Up to 28 daysDescription: CRP is assessed by routinely used determination of CRP.
Measure: Identification of biomarkers (C-reactive protein) Time: Up to 14 daysDescription: IL-6 levels will be assessed using commercial ELISA method
Measure: Identification of biomarkers (Interleukin-6) Time: Up to 14 daysDescription: Tumor Necrosis Factor-alpha as measured in hospital laboratory
Measure: Identification of biomarkers (Tumor Necrosis Factor-alpha) Time: Up to 14 daysDescription: Descriptive statistics, including means, standard deviations, and ranges for continuous variables, as well as percentages and frequencies for categorical variables, will be provided to describe all the clinical findings in a cohort of symptomatic COVID-19-infected subjects. The collected data will also be graphically presented in boxplots, histograms, and scatter plots. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity, will be made. Group comparisons will be made using either the parametric tests such as t-test and ANOVA, or the non-parametric statistical method such as Wilcoxon and Kruskal-Wallis tests for continuous variable and Chi-square test for categorical variables. Point estimates, along with the corresponding p-values and 95% confidence intervals will be reported.
Measure: Identification of adverse events Time: Up to 14 daysThis phase II trial studies how well lopinavir/ritonavir works in treating COVID-19 positive patients with cancer and a weakened immune system (immune-suppression) in the last year and have mild or moderate symptoms caused by COVID-19. Lopinavir/ritonavir may help to lessen or prevent COVID-19 symptoms from getting worse in cancer patients.
Description: Will be compared to the time of randomization. The severity of symptoms will be categorized as mild, moderate, severe, or critical according to the grading of symptoms. The proportion of participants with progression to more severe symptoms between treatments groups will be compared using a Fisher's Exact test at a 0.05 significance level.
Measure: Severity of symptoms Time: 3 monthsDescription: Will be defined as improvement on symptoms: yes or no. Will be compared between treatment groups using log-rank test. A 95% confidence interval of treatment rate difference in symptom progression will be calculated by the Wald method.
Measure: Clinical benefit rate of lopinavir/ritonavir Time: 3 monthsDescription: Will be compared between treatment groups using log-rank test.
Measure: Time to symptom progression Time: From randomization to the first documented symptoms progression, assessed up to 3 monthsDescription: Will be compared between treatment groups using log-rank test.
Measure: Time to improvement of participants Time: From randomization to first documented complete resolution of symptoms, assessed up to 3 monthsDescription: Will be compared between treatment groups using log-rank test.
Measure: Time to hospital admission for those who develop severe of critical symptoms Time: From time of randomization to the time of hospital admission, assessed up to 3 monthsDescription: Will be compared using Fisher's exact test, and point and interval estimates will be provided.
Measure: Intensive care unit (ICU) admission: yes or no Time: 3 monthsDescription: Will be compared using Fisher's exact test, and point and interval estimates will be provided.
Measure: Receiving ventilator support: yes or no Time: 3 monthsDescription: Will be compared using Fisher's exact test, and point and interval estimates will be provided.
Measure: Overall survival Time: From randomization to death due to any cause, assessed up to 3 monthsDescription: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.
Measure: Potassium level Time: 3 monthsDescription: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.
Measure: Blood oxygen level Time: 3 monthsDescription: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.
Measure: Creatinine level Time: 3 monthsDescription: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.
Measure: Blood pressure Time: 3 monthsDescription: Will evaluate on a subjective basis the ability to remotely consent, monitor and treat patients in the context of a pandemic of a contagious disease. The proportion of participants able to be remotely consented, monitored, and treated in the context of a pandemic of a contagious disease will be tabulated and compared using the chi-square test.
Measure: Ability to remotely consent, monitor, and treat patients in the context of a pandemic of a contagious disease Time: 3 monthsThis phase I/II trial investigates the best dose and side effects of leflunomide and how well it works in treating patients with COVID-19 and a past or present cancer. Leflunomide has been used since the 1990s as a treatment for rheumatoid arthritis. Experiments done with human cells that were given severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19, showed that leflunomide was able to reduce the ability of the virus to make copies of itself. The coronavirus uses ribonucleic acid (RNA), a very long molecule that contains genetic information that is like a blueprint for making more copies of itself. Leflunomide inhibits the formation of RNA. The information gained from this study may help researchers to learn whether leflunomide is safe for use in treating patients with COVID-19, and whether it is potentially effective against the disease.
Description: Observed toxicities will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study of treatment and reversibility or outcome.
Measure: Incidence of toxicity, graded according to the NCI CTCAE version 5 Time: Up to 28 days after completion of study treatmentDescription: Will be based on the assessment of dose limiting toxicity (DLT).
Measure: Maximum tolerated dose (MTD) (Phase 1) Time: During the 28-day treatment periodDescription: Defined as a >= 2-point change in clinical status from day 1 on a 7-point ordinal scale.
Measure: Clinical activity (Response)(Phase 2) Time: At day 28Description: Defined as time from start of treatment to >= 2 point change in clinical status on a 7 point ordinal scale
Measure: Time to Clinical activity (Response) Time: Up to 28 daysDescription: Defined as time from start of treatment to death from any cause
Measure: Overall Survival Time: Up to 90 daysDescription: Time from start of treatment to peripheral capillary oxygen saturation (SpO2) > 93% on room air
Measure: Oxygen Saturation improvement Time: Up to 90 daysDescription: Time from start of treatment to first negative severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) result assessed by polymerase chain reaction (PCR).
Measure: SARS-CoV-2 resolution Time: Up to 90 daysDescription: Hospitalized within first 90 days following start of treatment assessed as yes/no
Measure: Hospitalization Time: Up to 90 daysDescription: Indication as to whether or not the subject required mechanical ventilation at any time from start of treatment through 90 days post; assessed as yes/no
Measure: Mechanical Ventilation required Time: Up to 90 daysDescription: If the subject required mechanical ventilation, indicate number of days for first occurrence; measured in days.
Measure: Mechanical Ventilation duration Time: Up to 90 daysDescription: Vital status will be reported as yes/no
Measure: Vital status (alive/dead) Time: Up to 90 daysDescription: If vital status is dead, cause of death will be documented.
Measure: Vital status (cause of death) Time: Up to 90 daysDescription: Measured by PCR assay of viral ribonucleic acid (RNA) from nasopharyngeal swab.
Measure: Viral load Time: from start of treatment to 90 daysThis phase I/II trial investigates the side effects and how well CD24Fc works in treating immune related adverse events in patients with solid tumors that have spread to other places in the body (advanced). CD24Fc may prevent autoimmune reactions due to the tissue damage induced by cancer treatment. CD24Fc binds to injured cell components and prevents inflammatory responses. CD24Fc also acts to turn off the immune system after it has been activated ("immune checkpoint"). Adding CD24Fc to standard treatment may shorten the recovery time and reduce the severity of side effects from immunotherapy.
Description: Will assess event of new AE of >= grade 3 that are outside the spectrum of immune related adverse events (irAEs) when CD24 extracellular domain-IgG1 Fc domain recombinant fusion protein CD24Fc (CD24Fc) is given in cancer patients who developed grade 2-3 irAEs. Toxicity is evaluated by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. The type, grade, frequency and proportion of toxicities noted during the treatment period will be reported, along with associated 95% confidence interval of proportion. All adverse events noted by the investigator will be tabulated according to the affected body system.
Measure: Incidence of new adverse event (AE) of >= grade 3 (Phase I) Time: At day 60Description: Defined by reduction of irAE by one grade. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Recovery rate (Phase II) Time: At day 42Description: Will assess time to recovery from grade 2 or 3 irAE (as defined by reduction of at least 1 grade in irAE severity) from the initiation of CD24Fc treatment. Patients who have not been documented to have event (reduction of at least 1 grade) will be censored at the date of the latest clinical assessment that documented as being free of event.
Measure: Time to recovery from grade 2 or 3 irAE (Phase II) Time: Up to 1 yearDescription: Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Time to irAE reduction by at least 1 grade from the initiation of CD24Fc treatment (Phase I) Time: Up to 1 yearDescription: Assessed by NCI CTCAE v5.0. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Time to all irAEs reduced to =< 1 from the initiation of CD24Fc treatment (Phase I) Time: Up to 1 yearDescription: Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Time to resume immune check point inhibitor (ICI) treatment from the initiation of CD24Fc treatment (Phase I) Time: Up to 1 yearDescription: The fraction of patients who experience a partial response (PR) or complete response (CR) will be determined by dividing the number of responders by the total evaluable patients. The fraction will be reported along with 95% two-sided confidence intervals. Comparisons between groups will be performed by Fisher's Exact tests. Will also characterize the proportion who remain that either respond or have stable disease, compared to those who progress.
Measure: Recovery rate (reduction of irAE by one grade) (Phase I) Time: At day 42Description: Assessed by NCI CTCAE v5.0. Kaplan-Meier plots and confidence intervals will be used to summarize outcomes. Medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox proportional hazard models will be used to explore association between covariates and outcomes.
Measure: Time to all irAEs reduced to =< 1 from the initiation of CD24Fc treatment (Phase II) Time: Up to 1 yearDescription: Descriptive statistics will be used to summarize use of steroids (drug, dose, duration) and other treatment for irAE.
Measure: Use of steroids and other drugs (drug, dose, duration) (Phase II) Time: Up to 1 yearDescription: The fraction of patients who experience a PR or CR will be determined by dividing the number of responders by the total evaluable patients. The fraction will be reported along with 95% two-sided confidence intervals. Comparisons between groups will be performed by Fisher's Exact tests. Will also characterize the proportion who remain that either respond or have stable disease, compared to those who progress.
Measure: Overall response rate after retreatment with ICI with or without CD24Fc after resolution of irAE (Phase II) Time: Up to 1 yearDescription: Kaplan-Meier plots and confidence intervals will be used to summarize PFS; medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox PH models will be used to explore association between outcomes and covariates.
Measure: Progression free survival (PFS) (Phase II) Time: From initiation of ICI to first documented evidence of disease progression or death, whichever comes first, assessed up to 1 yearDescription: Kaplan-Meier plots and confidence intervals will be used to summarize OS; medians and associated 95% confidence intervals will be calculated, and comparisons between groups will be performed by log-rank tests. Cox PH models will be used to explore association between outcomes and covariates.
Measure: Overall survival (OS) (Phase II) Time: From diagnosis to death, assessed up to 1 yearAlphabetical 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