European Phase 4 Study Testing Tecovirimat for Treating Monkeypox Infection with Oral Capsules

What this Trial Is About

Researchers are evaluating the drug tecovirimat in adults with mpox infection, also known as monkeypox, in this randomized controlled double-blind clinical trial. The study aims to determine if tecovirimat is effective and safe for treating mpox. Participants must have confirmed mpox infection with active skin or mucosal lesions to join the trial. Participants will be randomly assigned to receive either oral tecovirimat capsules or a matching placebo. The tecovirimat group will take 600 mg twice daily three 200 mg capsules each dose for 14 days, totaling 28 doses. The placebo group will follow the same schedule with identical capsules but without the active drug. During the study, researchers will closely monitor participants mpox lesions, symptoms, and overall condition. They will assess the time it takes for lesions to fully heal within 28 days, symptom resolution up to 90 days, and any side effects or complications. Other outcomes include quality of life changes, virus clearance from skin or mucosal swabs, and hospital admissions. Safety will be evaluated throughout the trial, which lasts up to 90 days after treatment starts.

European Trial Into Mpox Infection