Pharmacokinetics, tolerability and safety of favipiravir compared to ribavirin for the treatment of Lassa Fever: A randomized controlled open label phase II clinical trial
- Conditions
- Lassa Fever
- Registration Number
- PACTR202010817169062
- Lead Sponsor
- Bernhard Nocht Institute for Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Age = 18 years
Lassa fever confirmed by PCR
Written informed consent
Inability to give consent (e.g. unconscious patients/ cognitively impaired patients)
Women who plan to get pregnant within the upcoming 6 months
Severe malnutrition (BMI<16)
Pregnancy/lactation (evidenced by negative urine pregnancy test in women of child-bearing potential)
Known intolerance to ribavirin or favipiravir
History of hemoglobinopathies (i.e., sickle-cell anaemia or thalassemia major) and/or haemophilia
Organ failure as evidenced by:
oCreatinine = 3x ULN
oALT/ AST > 150 IU/l
oACVPU score = V or P or U (corresponds to GCS = 12)
oSevere central nervous system features (e.g. seizures, restlessness, confusion or coma)
oO2 Saturation < 90%
oHematocrit <30 %
oSevere anaemia requiring blood transfusion
Inability to take oral drug (e.g. encephalopathy, severe vomiting)
Patients who already received ribavirin or favipiravir within the preceding 7 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method