Yellow fever
Conditions
Interventions
Regimen 1 - Intervention: 45 patients will receive Sofosbuvir 400 mg once a day per 10 days + clinical intervention at attending physician´s discretion
Regimen 2 - Control: 45 patients will receive cl
Drug
Sponsors
Fundação Faculdade de Medicina
Fundação Faculdade de Medicina
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age above 18 years, admission in one of the recruiting centers, fever (axillary temperature above 37.8°C), coming from a risk region with epizootic or confirmed human cases (defined according to updated epidemiological bulletins), transaminases above 500 U/L.
Exclusion criteria
Exclusion criteria: amiodarone use in the last 72 hours, current pregnancy, women who do not accept interruption of breastfeeding, current use of sofosbuvir for hepatitis C treatment, negative RT-PCR for yellow fever, alternative diagnosis that justifies the symptoms on admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in the viral load of the yellow fever virus (blood), measured 72 hours after the randomization, tested by quantitative polymerase chain reaction. ;Time for polymerase chain reaction negativation. The polymerase chain reaction test will be collected each study visit until its negativation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Attainment of clinical criteria for intensive care: AST or ALT >3000 U/L, RNI > 1.5, Platelets 1.2 mg/dL ou 50% increase in baseline creatinin), homorragy, encefalopathy over grade 1 or seizures. Those criteria will be assessed in the visits of the sutdy.;Liver transplantation. Assessed by the proportion of patients who were transplanted.;In-hospital mortality. Assessed by the proportion of patients who died during hospitalization.;Mortality within 60 days. Assessed by the proportion of patients who died during the first 60 studied days. | — |
Countries
Brazil
Contacts
Public ContactClaudia Mello
Instituto de Infectologia Emílio Ribas
Outcome results
None listed