Irrua

Lassa fever is a viral hemorrhagic fever causing significant deaths in West Africa, with a 12% in-hospital mortality rate. It spreads mainly through exposure to rodent excreta and sometimes from person to person, leading to hospital outbreaks. Current treatment with ribavirin has concerns about safety, effectiveness, and cost, highlighting the urgent need for new therapies. This multinational phase II-III trial aims to compare new or repurposed drugs against the standard care for hospitalized patients with confirmed Lassa fever. The trial evaluates multiple treatment arms including oral favipiravir at two dosing levels, intravenous ribavirin using the Irrua regimen, combination therapy of favipiravir plus ribavirin, ribavirin with dexamethasone, and two dosing regimens of ARN-75039. Treatments are administered over 10 days during hospitalization. The study uses an open-label, randomized design to compare the efficacy and safety of investigational drugs versus standard care. Participants will be hospitalized for 10 days with follow-up for 28 days. Researchers will assess death, organ failure, and other clinical outcomes such as kidney and respiratory function. Safety and tolerability will be monitored throughout treatment and follow-up. Virological and biological parameters will be measured at multiple time points, along with pharmacokinetics studies. The trial will help determine optimal dosing and compare outcomes across treatment groups over the study period.

Lassa fever is a serious and often deadly disease caused by the Lassa virus, mainly affecting people in West Africa. This research aims to evaluate the safety and side effects of adding dexamethasone, a corticosteroid that may reduce harmful inflammation, to the standard antiviral treatment ribavirin for moderate to severe cases of Lassa fever. The study is a phase II, open-label, randomized clinical trial designed to understand how dexamethasone influences disease progression and immune responses. Participants will be randomly assigned to one of two groups one receiving ribavirin alone and the other receiving ribavirin combined with dexamethasone. Dexamethasone will be given intravenously for the first 48 hours, then possibly switched to oral form for the remaining 8 days. Ribavirin treatment will be administered intravenously for 10 days according to national guidelines. The trial will last at least 10 days after enrollment for each participant. During the study, participants will be closely monitored for adverse effects and changes in their health status, including blood tests to measure liver and kidney function, immune markers, and viral load. Researchers will also study how dexamethasone is processed in the body. Follow-up assessments will continue until 10 days after enrollment to evaluate safety, disease outcomes, and biological responses. The overall goal is to better understand the potential role of dexamethasone as an additional treatment for Lassa fever.