A Phase 1 dose-finding trial in Zambia and Kenya selected 3 mg/kg per infusion as the maximum tolerated dose of sevuparin for children hospitalized with severe malaria. Investigators reported dose-limiting coagulation abnormalities at higher doses (4–6 mg/kg) but none at 3 mg/kg, establishing a safer range for subsequent efficacy studies. Sevuparin, a heparin-like compound, targets microvascular pathology in severe malaria by aiming to reduce sequestration of parasite-infected red blood cells. The trial design used continual reassessment as coagulation labs accumulated, focusing on tolerability rather than survival benefit. With limited supportive-therapy evidence in severe malaria, the selected dosing range becomes a critical gating step toward larger randomized trials that can test whether adjunctive anticoagulation meaningfully improves outcomes.
Get the Daily Brief