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IV Ribavirin for Hemorrhagic Fever With Renal Syndrome (HFRS)
NCT04283513Phase 2
Key facts
- Status
- Suspended
- Start
- Oct 2022
- Primary completion
- Apr 2027
- Countries
- 1
- Sponsor
- U.S. Army Medical Research and Development Command
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- ribavirin
- Conditions
- hemorrhagic fever with renal syndrome (HFRS)
01
Overview
Phase 2, open-label, single-arm trial of ribavirin in hemorrhagic fever with renal syndrome (HFRS), sponsored by U.S. Army Medical Research and Development Command. Primary endpoint: Reduction in Mortality at 10 days. Started Oct 2022; status: suspended.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Efficacy of IV Ribavirin
Loading dose 33 mg/kg, then 16 mg/kg every 6h for 4 days, then 8 mg/kg every 8h for 3 days.
03
Who it enrols
DoD-affiliated personnel aged 17-65 with probable or suspected HFRS, hemoglobin >= 10 g/dL, and CrCl >= 20 mL/min. Excludes pregnant women, those with severe cardiac disease, autoimmune hepatitis, or taking didanosine/azathioprine.
04
Endpoints
Primary
Reduction in Mortality
Secondary
Adverse Events
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