Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Name (Synonyms) | Correlation | |
---|---|---|
drug101 | ACT-541478 high or low dose (or placebo) Wiki | 0.50 |
drug96 | ACT-541478 100 mg Wiki | 0.50 |
drug98 | ACT-541478 30 mg Wiki | 0.50 |
Name (Synonyms) | Correlation | |
---|---|---|
drug2429 | Monodose RS01 Wiki | 0.50 |
drug99 | ACT-541478 300 mg Wiki | 0.50 |
drug100 | ACT-541478 dose E1 Wiki | 0.50 |
drug97 | ACT-541478 1000 mg Wiki | 0.50 |
drug95 | ACT-541478 10 mg Wiki | 0.50 |
drug2227 | MAS825 Wiki | 0.50 |
drug2593 | Non interventional study Wiki | 0.50 |
drug120 | ARALAST NP Wiki | 0.50 |
drug1616 | GSK3923868 Wiki | 0.50 |
drug721 | COVI-AMG Wiki | 0.50 |
drug468 | BI 764198 Wiki | 0.29 |
drug2916 | Placebo Wiki | 0.02 |
Name (Synonyms) | Correlation | |
---|---|---|
D004646 | Emphysema NIH | 0.35 |
D019896 | Alpha 1-Antitrypsin Deficiency NIH | 0.35 |
D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.26 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0006510 | Chronic pulmonary obstruction HPO | 0.26 |
HP:0002099 | Asthma HPO | 0.14 |
HP:0006536 | Pulmonary obstruction HPO | 0.13 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0002088 | Abnormal lung morphology HPO | 0.10 |
HP:0001919 | Acute kidney injury HPO | 0.10 |
HP:0002090 | Pneumonia HPO | 0.03 |
Navigate: Correlations HPO
There are 4 clinical trials
To investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of multiple rising doses per day over 14 days and to explore the pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing. In addition, the effect of BI 764198 on the pharmacokinetics of midazolam, given as an oral microdose, will be explored after multiple oral dosing.
The study will assess the efficacy and safety of MAS825 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function
Description: The APACHE II ("Acute Physiology And Chronic Health Evaluation II") is a severity-of-disease classification system. An integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death. Worst case imputation for death will be applied.
Measure: APACHE II severity of disease score on Day 15 or on day of discharge (whichever is earlier) Time: Up to 15 daysDescription: C-reactive protein (CRP) is a blood test marker for inflammation in the body. For a standard CRP test, a normal reading is less than 10 milligram per liter (mg/L). It will be analyzed on a logscale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline CRP as a covariate.
Measure: Serum C-reactive protein (CRP levels) Time: Up to 15 daysDescription: Ferritin is a blood test marker for inflammation in the body. For a standard Ferritin test, a normal reading is less than 300 micrograms per liter (μg/L). It will be analyzed on a logscale fitting a repeated measures mixed model including treatment group, study day, the three stratification factors and log transformed baseline Ferritin as a covariate.
Measure: Ferritin levels Time: Up to 15 daysDescription: Proportion of participants without the need for invasive mechanical ventilation for survival.
Measure: Proportion of participants without the need for invasive mechanical ventilation Time: Day 15, Day 29Description: Clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). -Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (noninvasive ventilation or highflow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). - Patients who die have a score 8.
Measure: Proportion of participants with at least one level improvement in clinical status Time: Day 15, Day 29Description: Clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). -Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (noninvasive ventilation or highflow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). - Patients who die have a score 8.
Measure: Clinical status over time Time: Up to 15 daysA study in healthy subjects to investigate the safety and tolerability of ACT-541478 as well as what ACT-541478 does to the body and the way the body takes up, distributes, and gets rid of of ACT-541478
This is a first time in human (FTIH) study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of single and repeat doses of GSK3923868 inhalation powder in both healthy participants and asthmatics. This is a 3-part, randomized, double blind, placebo controlled study of GSK3923868, administered as an inhalation powder blend (GSK3923868 capsules for inhalation) via Mono-dose inhaler in healthy participants (Parts A and B) and in participants with asthma (Part C). The duration of study participation for each part A, B and C will be 11, 9 and 8 weeks, respectively.
Description: AEs and SAEs will be collected.
Measure: Part A: Number of participants with adverse events (AEs) and serious adverse events (SAEs) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: AEs and SAEs will be collected.
Measure: Part B: Number of participants with AEs and SAEs Time: From start of the treatment (Day 0) to Day 18Description: AEs and SAEs will be collected.
Measure: Part C: Number of participants with AEs and SAEs Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the assessment of hematology laboratory (lab) parameters.
Measure: Part A: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part A: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part A: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the assessment of hematology lab parameters.
Measure: Part B: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part B: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part B: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 18Description: Blood samples will be collected for the assessment of hematology lab parameters.
Measure: Part C: Number of participants with clinically significant changes in hematology lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the assessment of clinical chemistry lab parameters.
Measure: Part C: Number of participants with clinically significant changes in clinical chemistry lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Urine samples will be collected for the assessment of urinalysis lab parameters.
Measure: Part C: Number of participants with clinically significant changes in urinalysis lab parameters Time: From start of the treatment (Day 0) to Day 8Description: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part A: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part B: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 18Description: Vital signs will be measured in a semi-supine position after atleast 10 minutes rest.
Measure: Part C: Number of participants with clinically significant vital signs Time: From start of the treatment (Day 0) to Day 8Description: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT intervals (QTc). The QT interval will be corrected for heart rate by Fredericia's formula (QTcF).
Measure: Part A: Number of participants with clinically significant abnormalities in 12-Lead electrocardiogram (ECG) findings Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.
Measure: Part B: Number of participants with clinically significant abnormalities in 12-Lead ECG findings Time: From start of the treatment (Day 0) to Day 18Description: Twelve-lead electrocardiogram will be performed in a semi-supine position using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc.
Measure: Part C: Number of participants with clinically significant abnormalities in 12-Lead ECG findings Time: From start of the treatment (Day 0) to Day 8Description: Spirometry measurements including forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) will be assessed
Measure: Part A: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Spirometry measurements including FEV1 and FVC will be assessed.
Measure: Part B: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 18Description: Spirometry measurements including FEV1 and FVC will be assessed.
Measure: Part C: Number of participants with clinically significant abnormalities in spirometry measurements Time: From start of the treatment (Day 0) to Day 8Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Area under the plasma GSK3923868 concentration versus time curve from time zero to last quantifiable concentration (AUC[0-t]) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentration of GSK3923868.
Measure: Part A, Cohort 1 and 2: Area under the plasma GSK3923868 concentration versus time curve from time zero to infinity (AUC[0-inf]) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Maximum observed GSK3923868 plasma concentration (Cmax) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part A, Cohort 1 and 2: Time to maximum observed plasma drug concentration (Tmax) Time: From start of the treatment (Day 0) to Day 2 in each treatment periodDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: AUC from time 0 (predose) to time tau (AUC [0-tau]) (tau=24hours for once a day dosing regimen) of GSK3923868 on Day 1 and Day 14 Time: Day 1 and 14: Up to 24 hours post doseDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: Cmax of GSK3923868 on Day 1 and Day 14 Time: Day 1 and Day 14Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part B, Cohort 3 and 4: Tmax of GSK3923868 on Day 1 and Day 14 Time: Day 1 and Day 14Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: AUC (0-tau) (tau=24hours for once a day dosing regimen)of GSK3923868 on Day 1 and Day 7 Time: Day 1 and 7: Up to 24 hours post doseDescription: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: Cmax of GSK3923868 on Day 1 and Day 7 Time: Day 1 and Day 7Description: Blood samples will be collected for the concentrations of GSK3923868.
Measure: Part C: Tmax of GSK3923868 on Day 1 and Day 7 Time: Day 1 and Day 7Alphabetical 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