Suakoko

Lassa fever is a viral hemorrhagic fever causing thousands of deaths annually in West Africa, with about 12% in-hospital mortality. It is primarily spread through contact with rodent excreta and can occasionally spread between humans, leading to hospital outbreaks. Current treatment relies on ribavirin, which has concerns regarding toxicity, effectiveness, and cost, creating an urgent need for new, safer medications. The World Health Organization has prioritized Lassa fever for urgent research, and the INTEGRATE consortium brings together international partners to address this need through clinical trials. This multinational, multi-center phase II-III trial evaluates the safety and effectiveness of three investigational drugs—Favipiravir, Dexamethasone, and ARN-75039 (in high and low doses)—compared to the standard treatment with ribavirin in hospitalized patients confirmed to have Lassa fever. The study uses an open-label, randomized design with parallel arms, assessing each investigational drug against the standard of care. The trial includes a hospitalization period of 10 days followed by a 28-day follow-up. Participants will be monitored throughout hospitalization and follow-up for outcomes including death and new organ failure events such as kidney, respiratory failure, or shock within the initial 10 days. Safety and tolerability of treatments will be assessed along with clinical, virological, and biological parameters. Pharmacokinetics and pharmacodynamics data will be collected to optimize dosing. The total study duration for each participant is 28 days, with close clinical and laboratory monitoring during and after treatment.