Closed to accrual
A5418: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Disease
Treatment Category
Study Description
A5418 (STOMP) is a study of tecovirimat (also known as TPOXX) for the treatment of human monkeypox virus (HMPXV) disease.
Study Purpose
- To see if tecovirimat is safe, and whether it helps treat monkeypox infection.
Target Participant
People with:
- Laboratory-confirmed or presumptive monkeypox infection
- Monkeypox illness of less than 14 days’ duration
- At least one active (not yet scabbed) skin lesion, mouth lesion, or proctitis (inflammation of the lining of the rectum) with or without visible ulcers
Study Details
Participants will be randomly assigned (like flipping a coin) in a 2:1 ratio to receive tecovirimat OR placebo for tecovirimat for 14 days.
People who are at higher risk for severe disease because of their age or their medical history will be assigned to receive open-label tecovirimat for 14 days.
All participants will be followed through a combination of in-person visits, specimen collection, virtual assessments, and self-reports and photographs of symptoms for about 2 months.
Treatments Or Drugs Involved With Study
Tecovirimat is a drug that may help to treat infections caused by pox viruses. Tecovirimat is approved by the Food and Drug Administration (FDA) to treat smallpox in adults and children, but its use in this study is considered investigational.
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