Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores |
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk. |
6 months |
|
Primary |
Efficacy of Treatment by Time to Non-Infectivity |
Time to non-infectivity as measured by PCR testing |
10 days |
|
Secondary |
Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores |
Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk. |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores. |
Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk. |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Complete Blood Count |
Changes in blood parameters measured in a Complete Blood Count (CBC). |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Complete Blood Count |
Changes in blood parameters measured in a Complete Metabolic Panel. |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel -Albumin |
Changes in serum albumin levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin |
Changes in serum albumin levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio |
Changes in serum albumin/globulin ratio |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio |
Changes in serum albumin/globulin ratio |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase |
Changes in serum alkaline phosphatase levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase |
Changes in serum alkaline phosphatase levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - AST |
Changes in serum AST levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - AST |
Changes in serum AST levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT |
Changes in serum ALT levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel ALT |
Changes in serum ALT levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio |
Changes in serum BUN/Creatinine Ratio |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio |
Changes in serum BUN/Creatinine Ratio |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN |
Changes in serum Blood Urea Nitrogen levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - BUN |
Changes in serum Blood Urea Nitrogen levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Calcium |
Changes in serum calcium levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium |
Changes in serum calcium levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide |
Changes in serum carbon dioxide levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide |
Changes in serum carbon dioxide levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Chloride |
Changes in serum chloride levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride |
Changes in serum chloride levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine |
Changes in serum creatinine levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine |
Changes in serum creatinine levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Globulin |
Changes in serum globulin levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin |
Changes in serum globulin levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose |
Changes in blood glucose levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Glucose |
Changes in blood glucose levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Potassium |
Changes in blood potassium levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium |
Changes in blood potassium levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin |
Changes in serum total bilirubin levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin |
Changes in serum total bilirubin levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein |
Changes in serum total protein levels |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein |
Changes in serum total protein levels |
6 months |
|
Secondary |
Safety of Dual Therapy as Measured by Treatment Related SAE |
Presence or absence of treatment related serious adverse events Grade III or higher |
6 months |
|
Secondary |
Safety of Quadruple Therapy as Measured by Treatment Related SAE |
Presence or absence of treatment related serious adverse events Grade III or higher |
6 months |
|