Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Cardiovascular Explanatory |
To identify the frequency of vascular leak |
through study completion, an average of 2 weeks |
|
Other |
Cardiovascular Explanatory |
To identify the frequency of cardiac function |
through study completion, an average of 2 weeks |
|
Other |
Cardiovascular Explanatory |
To identify the frequency of total peripheral resistance |
through study completion, an average of 2 weeks |
|
Other |
Cardiovascular Explanatory |
To identify the frequency of total body water |
through study completion, an average of 2 weeks |
|
Other |
Cardiovascular Explanatory |
To identify the frequency of Reactive hyperaemic index |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacokinetics Explanatory |
Age |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacokinetics Explanatory |
Gender |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacokinetics Explanatory |
Calculation of eGFR |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacokinetics Explanatory |
Calculation of Total body water |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacokinetics Explanatory |
ITPA, SLC28 gene polymorphisms |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacodynamics Explanatory |
Calculation of AUC [AUC8 and AUCLAST] |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacodynamics Explanatory |
Calculation of CMAX |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacodynamics Explanatory |
Calculation of CMIN |
through study completion, an average of 2 weeks |
|
Other |
Ribavirin Pharmacodynamics Explanatory |
ITPA, IL28B and SLC28/29 gene polymorphisms |
through study completion, an average of 2 weeks |
|
Primary |
Cardiovascular |
Mean Arterial Pressure is less than 65mmHg or Systolic Blood Pressure is less than 90mmgHg or pulse pressure < 20mmHg |
through study completion, an average of 2 weeks |
|
Primary |
Ribavirin Pharmacokinetics |
Proportion of patients with ribavirin CMIN above the IC90 at > 80% of measured CMIN during therapy |
through study completion, an average of 2 weeks |
|
Primary |
Ribavirin Pharmacodynamics |
Change in Lassa virus Viral Load from baseline to day 5 |
5 days |
|
Secondary |
Cardiovascular |
To identify the frequency of shock |
through study completion, an average of 2 weeks |
|
Secondary |
Cardiovascular |
To identify the frequency of persistent shock |
through study completion, an average of 2 weeks |
|
Secondary |
Cardiovascular |
To identify the frequency of respiratory distress |
through study completion, an average of 2 weeks |
|
Secondary |
Cardiovascular |
To identify the frequency of shock and respiratory distress |
through study completion, an average of 2 weeks |
|
Secondary |
Cardiovascular |
To identify the frequency of Death |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacokinetics |
Proportion of patients with ribavirin CMIN above the IC50 at all measured CMIN during therapy |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacokinetics |
Duration of time that ribavirin levels are above the IC90 and IC50 |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacokinetics |
Calculation of AUC [AUC8 and AUCLAST] (ribavirin, ribavirin metabolites) |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacokinetics |
Calculation of CMAX (ribavirin, ribavirin metabolites) |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacokinetics |
Calculation of CMIN (ribavirin, ribavirin metabolites) |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacokinetics |
Calculation of T1/2 (ribavirin, ribavirin metabolites) |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacokinetics |
Volume of distribution (ribavirin, ribavirin metabolites) |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacokinetics |
Calculation of Clearance (ribavirin, ribavirin metabolites) |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacodynamics |
Change in Lassa virus Viral Load from baseline to day 3 and day 10 |
10 days |
|
Secondary |
Ribavirin Pharmacodynamics |
Change in AST, ALT concentrations from baseline to day 3, 5, 10 |
10 days |
|
Secondary |
Ribavirin Pharmacodynamics |
Change in eGFR from baseline to day 3, 5, 10 |
10 days |
|
Secondary |
Ribavirin Pharmacodynamics |
Change in Haemoglobin from baseline to day 5, 10 |
10 days |
|
Secondary |
Ribavirin Pharmacodynamics |
Change in ISG expression from baseline to day 3, 5 |
5 days |
|
Secondary |
Ribavirin Pharmacodynamics |
Time to negative blood RT-PCR for Lassa virus |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacodynamics |
Requirement for blood transfusion during hospitalisation |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacodynamics |
Reaching KDIGO stage 3 during hospitalisation |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacodynamics |
Requirement for dialysis during hospitalisation |
through study completion, an average of 2 weeks |
|
Secondary |
Ribavirin Pharmacodynamics |
Duration of hospitalisation |
through study completion, an average of 2 weeks |
|