|drug237||Anakinra and Zinc Wiki||1.00|
|D006506||Hepatitis A NIH||1.00|
|D006519||Hepatitis, Alcoholic NIH||1.00|
There is one clinical trial.
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Description: The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.Measure: Survival at 90 days Time: 90 days
Description: Score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101*(age, years) + 0.147*(albumin day 0, g/L) + 0.0165* (evolution in bilirubin level, µmol/L) - 0.206*(renal insufficiency) - 0.0065*(bilirubin day 0, µmol/L) - 0.0096*(PT, sec) Renal insufficiency = 1 (if Cr >1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L))Measure: Changes is Lille score Time: 7, 30, and 90 days
Description: The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.Measure: Changes in MELD score Time: 7, 30, and 90 days
Description: Increase in creatinine of 50% above baseline over a period of 7 days Increase in creatinine of 0.3 mg/dl within a period of 48 hrs Onset of renal failure requiring dialysisMeasure: Progression of the development of AKI (acute kidney injury) Time: 7, 30, and 90 days
Description: Defined as failure ≥2 organsMeasure: Progression of the development of multi-organ failure Time: 7, 30, and 90 days
Description: Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 pointsMeasure: Progression of the development of SIRS (Systemic Inflammatory Response Syndrome) Time: 7, 30, and 90 days
Description: Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalationMeasure: Number of Transfers to ICU Time: 7, 30, and 90 days
Description: New onset of ascites if not present on admission to study New onset of variceal hemorrhage New onset of hepatic encephalopathy (HE).Measure: Rate of changes in liver function Time: 7, 30, and 90 days
Description: The SOFA score will be modified and re-evaluated without platelet counts given that these are usually low in AH.Measure: Measure of changes in sequential organ failure Assessment (SOFA) scores and proportions requiring hemodynamic support for MAP < 65 mm Hg and lactate > 2 mmol/l, renal replacement therapy or mechanical ventilation. Time: 180 days
Description: Pneumonia defined as new infiltrate by CXR or Chest CT scan not explained by "fluid overload" Positive blood cultures for bacteria or fungus, not suspected as contaminant Positive urine fungal culture > 50,000 colonies/ml Positive urine bacterial culture > 100,000 colonies/ml (mixed flora is excluded) Soft tissue or bone infections including cellulitis or abscess documented by exam or scan CNS infection defined as positive culture of CSF or > 5 WBC/ml Ascitic fluid white cell count >500/ml or neutrophils>250/ml. with or without positive bacterial or fungal culturesMeasure: Measuring the types of infections Time: 180 days
Description: Life-threatening organ dysfunction caused by a dysregulated host response to infection An increase in SOFA score of 2 points of more Note: most participants with severe AH have 4 points based on bilirubin onlyMeasure: Rate of the progression of sepsis Time: 180 days
Description: Defined by a creatinine > 2 mg/dlMeasure: Rate of the progression of renal dysfunction Time: 180 days
Description: Proportion of participants requiring transfer to ICU for care, intubation for airway control, need for ventilator support or RRT.Measure: Need for care escalation Time: 180 days
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