Efficacy and Safety of Ivermectin Against Dengue Infection

A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection

This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Ivermectin in Children and Adult patients with Dengue Infection.

Patients with confirmed dengue infection who meet all inclusion and exclusion criteria will be enrolled in the study and admitted in the hospital. Patients will be randomly assigned in a pre-specified ratio of 1:1:1 to one of the following study groups: ivermectin 200-400 µg/kg single daily dose for 2 days, ivermectin 200-400 µg/kg single daily dose for 3 days, or placebo. Tablets of ivermectin or placebo will be administered for 3 days. Clinical exam will be performed daily during hospitalization and blood samples will be collected for hematology, clinical chemistry, serology, viral load and quantitative nonstructural 1 (NS1) antigen. Safety assessment will be conducted during admission. Patients will be discharged one day after fever subsidence and will be asked to return 2 weeks after first dose of study medication for safety assessment and blood sampling.

Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.

Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.

Inclusion Criteria: Adults ages of 15 or greater. History or presence of fever (temperature > 38°C) of ≤ 72 hr duration. Clinical suspicion of dengue infection such as high fever without an evidence or suspected focus of infection on clinical examination. Positive NS 1 strip assay Exclusion Criteria: Clinically significant abnormal laboratory results which are deemed to be unassociated with dengue infection Clinical evidence or a history of significant respiratory, metabolic, renal, hepatic, hematologic or chronic diseases History of autoimmune, immune dysfunction disorder or taking warfarin Clinical suspicion of any bacterial infection Pregnancy and lactating women

Division of Dengue Hemorrhagic Fever Research Department of Research and Development, Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok 10700, THAILAND

Ooi EE. Repurposing Ivermectin as an Anti-dengue Drug. Clin Infect Dis. 2021 May 18;72(10):e594-e595. doi: 10.1093/cid/ciaa1341. No abstract available.