Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3841 | SyB V-1901 Wiki | 0.45 |
| drug3966 | Text message Wiki | 0.45 |
| drug2137 | Lifestyle intervention Wiki | 0.45 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002908 | Chronic Disease NIH | 0.36 |
| D063766 | Pediatric Obesity NIH | 0.18 |
| D051436 | Renal Insufficiency, Chronic NIH | 0.15 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012622 | Chronic kidney disease HPO | 0.15 |
| HP:0000077 | Abnormality of the kidney HPO | 0.12 |
| HP:0005978 | Type II diabetes mellitus HPO | 0.11 |
Navigate: Correlations HPO
There are 5 clinical trials
The study hypothesis is that cyclosporine, added to standard treatment of hospitalized patients with COVID19 infection may improve their prognosis.
Description: efficacy of the association of CsA with standard treatment in reducing the severity of COVID19 infection in hospitalized patients.
Measure: Severity Category Time: 12 daysDescription: efficacy of CsA in combination with standard treatment in reducing mortality
Measure: Mortality Rate Time: through study completion, an average of 6 weeksDescription: efficacy of CsA in combination with standard treatment in reducing days in hospital
Measure: Number of Days in hospital Time: through study completion, an average of 6 weeksDescription: efficacy of CsA in combination with standard treatment in reducing days in ICU beds
Measure: Number of days in ICU beds Time: through study completion, an average of 6 weeksDescription: efficacy of CsA in combination with standard treatment in reducing FiO2 needs.
Measure: Fio2 Needs Time: through study completion, an average of 6 weeksDescription: safety and tolerability of cyclosporine vs standard treatment administration
Measure: Adverse events rate Time: through study completion, an average of 6 weeksDescription: change from baseline in C reactive protein levels
Measure: Change in CRP Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)Description: change from baseline in ferritin levels
Measure: Change in ferritin Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)Description: change from baseline in LDH levels
Measure: Change in LDH Time: every 48h during hospitalization and end of study visit (14 days after discharge or 14 days after end of study treatment)Description: change from baseline in Creatin phosphokinase levels
Measure: Change in CPK Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)Description: change from baseline in D Dimer levels
Measure: Change in D Dimer Time: every 48 hours from randomization until patient discharge, and at the end of study visit (14 days after discharge or 14 days after end of study treatment, depending of what applies)Description: change from baseline in IL-6 levels
Measure: Change in IL-6 Time: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)Description: change from baseline in KL-6 levels
Measure: Change in KL-6 Time: Days 1, 8, 15 and end of study visit (14 days after discharge or 14 days after end of study treatment)Description: COVID19 Viral load determination
Measure: Change in Viral Load Time: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)Description: Specific IgG and IgM determination
Measure: Change specific antibodies Time: Days 1,8,15 and end of study visit (14 days after discharge or 14 days after end of study treatment)Phase 1 safety study to determine the tolerability, clinical effects, and changes in laboratory parameters of short course oral or IV cyclosporine (CSA) administration in patients with COVID-19 disease requiring oxygen supplementation but not requiring ventilator support.
Description: Safety will be measured: By assessing the proportion of participants requiring increase in oxygen requirements, transfer to intensive care unit, and/or mechanical ventilation
Measure: Safety-oxygen, ICU transfer and ventilation Time: 3 monthsDescription: Safety will be assessed: By monitoring changes in absolute lymphocyte counts
Measure: Safety-changes in absolute lymphocyte count Time: 3 monthsDescription: Safety will be assessed: By monitoring changes in creatinine clearance. Creatinine clearance will be estimated using the Cockcroft-Gault formula.
Measure: Safety-changes in creatinine clearance Time: 3 monthsDescription: Safety will be assessed: By monitoring the incidence of secondary bacterial infections complicating COVID-19 hospitalization
Measure: Safety-secondary bacterial infections Time: 3 monthsDescription: To measure time to SARS-CoV-2 clearance (PCR negativity) at Days 7 and 14 by deep nasal swab
Measure: Laboratory measurements of safety and antiviral efficacy related to COVID-19-SARS-CoV-2 by measuring the clearance of SARS-CoV-2 from respiratory secretions Time: 3 monthsDescription: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: D-dimer levels
Measure: Laboratory measurements-D-dimer levels Time: 3 monthsDescription: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: ferritin levels
Measure: Laboratory measurements-ferritin Time: 3 monthsDescription: To measure the laboratory correlatives of CRS/ Hemophagocytic lymphohistiocytosis (HLH) by measuring: IL-6 levels
Measure: Laboratory measurements- IL-6 Time: 3 monthsPhase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no CSA + SOC. The primary endpoint is disease severity based on the World Health Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include safety and changes in serum inflammatory markers.
Description: WHO COVID-19 clinical severity scale
Measure: WHO COVID-19 clinical severity scale Time: Through study completion, an average of 1 month.This Phase 1 study aims to quantify the effects of cyclosporine, a broad transporter inhibitor, and rifampicin, an OATP1B1/3 inhibitor, on verinurad pharmacokinetics (PK). The study is conducted in accordance with Food and Drug Administration guidance on Clinical Drug Interaction Studies, 2020. Verinurad will be developed as a fixed combination since it will always be administered together with allopurinol.
Description: Verinurad Cmax ratio of geometric mean of test treatment (verinurad+allopurinol with (cyclosporine or rifampicin), relative to reference treatment (verinurad+allopurinol alone) in each treatment period
Measure: Geometric mean ratio of maximum observed plasma peak concentration (Cmax) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Verinurad AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of area under plasma concentration-time curve from time zero to infinity (AUCinf) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Verinurad AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of area under the plasma concentration-time curve from zero to time of last quantifiable concentration (AUClast) for verinurad Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for verinurad metabolite: M1 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for verinurad metabolite: M8 Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Allopurinol AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for allopurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol Cmax ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of Cmax for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol AUCinf ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUCinf for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Oxypurinol AUClast ratio of geometric means of test treatment, relative to reference treatment in each treatment period
Measure: Geometric mean ratio of AUClast for oxypurinol Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Cmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Cmax Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUCinf of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: AUCinf Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUClast of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: AUClast Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: AUC(0-24) of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Area under the concentration-time curve from time zero to 24 hours post-dose [AUC(0-24)] Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: tmax of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Time to reach peak or maximum observed concentration following drug (tmax) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: t½λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: λz of verinurad, M1, M8, allopurinol and oxypurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Terminal elimination rate constant (λz) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: CL/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MRTinf of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Mean Residence Time of the unchanged drug in the systemic circulation (MRTinf) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Vss/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Volume of distribution (apparent) at steady state following extravascular administration (Vss/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Vz/F of verinurad and allopurinol when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of Cmax for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: Metabolite:Parent (MP) ratio of Cmax Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of AUCinf for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: MP ratio of AUCinf Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: MP ratio of AUClast for verinurad when verinurad+allopurinol administered alone or in combination with cyclosporine or rifampicin in each treatment period
Measure: MP ratio of AUClast Time: Days 1 to 5: 30 minutes pre-dose and up to 96 hours post-doseDescription: Observed values and change from baseline value in systolic and diastolic BP for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal blood pressure (BP) Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in pulse rate for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal pulse rate Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in temperature for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal temperature Time: For approximately 9 weeks (from screening to follow-up)Description: 12-lead resting ECG safety assessments if there are any abnormal findings for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal 12-lead electrocardiogram (ECG) Time: At screening and post-treatment follow-up visit (7-14 day after last dose of verinurad)Description: Any new or aggravated clinically relevant abnormal medical physical examination finding compared to the baseline assessment for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal physical examination Time: For approximately 9 weeks (from screening to follow-up)Description: Observed values and change from baseline value in hematology parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal hematology parameters Time: At screening, Day -1, Day 3 (Treatment Periods 1, 2 and 3) and post-treatment follow-up (7-14 days after last dose of verinurad)Description: Observed values and change from baseline value in clinical chemistry parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal clinical chemistry parameters Time: At screening, Day -1 (Treatment Periods 1 and 3), Day 1, Day 2 and Day 3 (Treament Period 1), and post-treatment follow-up (7-14 days after last dose of verinurad)Description: Observed values and change from baseline value in urinalysis parameters for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with abnormal urinalysis parameters Time: At screening, Day -1 (Treatment Periods 1 and 3), Day 1, Day 2 and Day 3 (Treament Period 1), and post-treatment follow-up (7-14 days after last dose of verinurad)Description: The number and percentage of subjects with AEs and the number of events for subjects administered with verinurad and allopurinol in combination with cyclosporine or rifampicin
Measure: Number of subjects with adverse events (AEs) and serious AEs Time: For approximately 9 weeks (from screening to follow-up)To evaluate the effect of coadministered cyclosporine on the pharmacokinetics of brincidofovir following simultaneous administration of SyB V-1901 with cyclosporine, or coadministration of cyclosporine at 2 hours after the completion of SyB V-1901 infusion in healthy adult subjects
Alphabetical 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