Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease

"The experimental intervention is tecovirimat, available as immediate-release capsules containing tecovirimat monohydrate, equivalent to 200 mg of tecovirimat. The route of administration of tecovirimat is oral. Tecovirimat treatment will be initiated as soon as possible after diagnosis.~The international recommended doses will be followed:~* 25 kg to less than 40 kg: 400 mg (two tecovirimat 200 mg capsules) every 12 hours for 14 consecutive days.~* 40 kg and above: 600 mg (three tecovirimat 200 mg capsules) every 12 hours for 14 consecutive days."

The control intervention is a placebo and its route of administration will be identical to the experimental intervention administration to allow treatment arm blinding.