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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1120 | Cytochrome P450 (CYP) Substrates Wiki | 0.71 |
| drug2752 | PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test) Wiki | 0.71 |
| drug1261 | Double-Blind NT-I7 Wiki | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D014456 | Ulcer NIH | 0.21 |
| D003092 | Colitis NIH | 0.21 |
| D003093 | Colitis, Ulcerative NIH | 0.21 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002583 | Colitis HPO | 0.21 |
| HP:0100279 | Ulcerative colitis HPO | 0.21 |
| HP:0100280 | Crohn's disease HPO | 0.21 |
Navigate: Correlations HPO
There are 2 clinical trials
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study will evaluate the effect of repeated infusions of risankizumab on the pharmacokinetics of sensitive probe substrates of Cytochrome P450 (CYP) enzymes in participants with moderately to severely active UC or CD. Risankizumab is an investigational drug being developed to treat trial participants with inflammatory diseases such as UC and CD. The study is split into two periods. In Period 1, participants will receive single oral doses of CYP sensitive probes and in Period 2, participants will receive risankizumab followed by single oral doses of CYP sensitive probes. Around 20 adult participants with moderately to severely active CD or UC will be enrolled in the study across multiple sites worldwide. In Period 1, participants will receive oral doses of CYP sensitive probes on Day 1. In Period 2, participants will receive risankizumab by intravenous (IV) infusion on Days 1, 29 and 57 followed by oral CYP sensitive probes on Day 64. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects.
Description: Maximum observed plasma concentration (Cmax) of Midazolam
Measure: Maximum Observed Plasma Concentration (Cmax) of Midazolam Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Midazolam
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Midazolam Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Midazolam Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Midazolam Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Midazolam
Measure: Terminal Phase Elimination Rate Constant (β) of Midazolam Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Midazolam
Measure: Terminal Phase Elimination Half-Life (t1/2) of Midazolam Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Caffeine
Measure: Maximum Observed Plasma Concentration (Cmax) of Caffeine Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Caffeine
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Caffeine Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Caffeine Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Caffeine Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Caffeine
Measure: Terminal Phase Elimination Rate Constant (β) of Caffeine Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Caffeine
Measure: Terminal Phase Elimination Half-Life (t1/2) of Caffeine Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Warfarin
Measure: Maximum Observed Plasma Concentration (Cmax) of Warfarin Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Warfarin
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Warfarin Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Warfarin Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Warfarin Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Warfarin
Measure: Terminal Phase Elimination Rate Constant (β) of Warfarin Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Warfarin
Measure: Terminal Phase Elimination Half-Life (t1/2) of Warfarin Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Omeprazole
Measure: Maximum Observed Plasma Concentration (Cmax) of Omeprazole Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Omeprazole
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Omeprazole Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Omeprazole Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Omeprazole Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Omeprazole
Measure: Terminal Phase Elimination Rate Constant (β) of Omeprazole Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Omeprazole
Measure: Terminal Phase Elimination Half-Life (t1/2) of Omeprazole Time: Up to 71 DaysDescription: Maximum observed plasma concentration (Cmax) of Metoprolol
Measure: Maximum Observed Plasma Concentration (Cmax) of Metoprolol Time: Up to 71 DaysDescription: Time to maximum plasma concentration (Tmax) of Metoprolol
Measure: Time to Maximum Observed Plasma Concentration (Tmax) of Metoprolol Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to time of the last measurable concentration
Measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) of Metoprolol Time: Up to 71 DaysDescription: Area Under the Plasma Concentration-time Curve (AUC) from time 0 to infinity
Measure: AUC From Time 0 to Infinity (AUCinf) of Metoprolol Time: Up to 71 DaysDescription: Terminal phase elimination rate constant (β) for Metoprolol
Measure: Terminal Phase Elimination Rate Constant (β) of Metoprolol Time: Up to 71 DaysDescription: Terminal phase elimination half-life (t1/2) of Metoprolol
Measure: Terminal Phase Elimination Half-Life (t1/2) of Metoprolol Time: Up to 71 DaysThis is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with COVID-19. BET is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 40 sites throughout the US. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention. The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses. One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 100 subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once. The BET-A stage will evaluate the combination of remdesivir with risankizumab vs remdesivir with a risankizumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.
Description: Clinical status assessed using ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Measure: Clinical efficacy in adults hospitalized with COVID-19 according to clinical status on an 8-point ordinal scale. Time: Day 8Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Change in National Early Warning Score (NEWS) from baseline Time: Day 1 through Day 29Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
Measure: Clinical efficacy, as assessed by time to recovery Time: Day 1 through Day 29Description: For any reason.
Measure: Discontinuation or temporary suspension of study product administration Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of hospitalization Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new mechanical ventilation or extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new non-invasive ventilation or high flow oxygen use during the study Time: Day 1 through Day 29Description: Measured in days; supplemental oxygen concentration or flow rate will be measured.
Measure: Duration of new oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of non-invasive ventilation/high flow oxygen use Time: Day 1 through Day 29Description: Supplemental oxygen concentration or flow rate will be measured.
Measure: Incidence of new oxygen use Time: Day 1 through Day 29Description: Clinical outcome assessed using ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Measure: Mean change in the ordinal scale Time: Day 1 through Day 29Description: Measured in days; supplemental oxygen concentration or flow rate will be measured.
Measure: Oxygenation use Time: Day 1 through Day 29Description: A subject who is "alive and without respiratory failure" is defined as meeting any one of the following five categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3)Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen.
Measure: Proportion of subjects alive and without respiratory failure Time: Day 1 to Day 29Description: Date and cause of death (if applicable).
Measure: Subject 14-day mortality Time: Day 1 through Day 15Description: Date and cause of death (if applicable).
Measure: Subject 29-day mortality Time: Day 1 through Day 29Description: Clinical outcome assessed using ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Measure: Time to an improvement of one category using an ordinal scale Time: Day 1 through Day 29Description: Clinical outcome assessed using ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death.
Measure: Time to an improvement of two categories using an ordinal scale Time: Day 1 through Day 29Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Time to discharge or to a National Early Warning Score (NEWS) of < / = 2 and maintained for 24 hours, whichever occurs first Time: Day 1 through Day 29Description: Measured in days.
Measure: Ventilator/ extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29Alphabetical 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