A5418 Study of Tecovirimat for Human Monkeypox Virus (STOMP)

Basic Study Information

Purpose:
This study will determine if the drug, tecovirimat, helps treat people you are infected with monkeypox virus. You must be 18 years of age or older to participate. You must have a positive laboratory test for monkeypox virus within 14 days of enrolling in the study and at least one skin lesion. Participants with severe disease, significant skin conditions, participants with severe immune suppression will receive open-label tecovirimat. Participants who are pregnant or breastfeeding will receive open-label tecovirimat after discussion of the potential risks and benefits. Participants less than 18 years of age will receive open-label tecovirimat. Participants receiving a potent inducing concomitant medication will receive open-label tecovirimat. Once enrolled, study drug administration will be for 14 days. Participants will self-monitor skin and/or mucosal lesions daily through 29 days or resolution (whichever comes first), complete a daily diary of symptoms and complete a daily numerical rating scale for pain assessment. Participants will be seen weekly through day 29 for assessment of HMPXV disease, safety assessments, HMPXV sampling similar to that described for entry, and swabbing of new HMPXV lesions. Participants will be seen at day 57 to assess for possible recrudescence of infection (i.e., new lesions occurring after initial resolution of disease.

Lead Researcher (Principal Investigator)

Lead Researcher:  Sonal Munsiff

Study Contact Information

Additional Study Details

Study Details:
About the A5418 Clinical Trial (STOMP) The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring a Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, for the treatment of human monkeypox infection. The NIAID-funded AIDS Clinical Trials Group (ACTG) is leading the study, which is now enrolling adults and children with monkeypox infection in the United States. Study investigators aim to enroll more than 500 people from up to 80 clinical research sites nationwide. Adults with severe monkeypox, severe immunodeficiency, or severe inflammatory skin conditions; individuals taking certain medications that could affect tecovirimat levels; and pregnant people, people who are breastfeeding and children all will be enrolled in an open-label arm in which all participants receive tecovirimat. Other adult participants—530 total—will be randomly assigned in a 2:1 ratio to receive tecovirimat or placebo pills, which participants will take for 14 days. This part of the trial is double-blind, meaning neither participants nor investigators will know who is receiving placebo or tecovirimat. Investigators will gather data to determine if participants receiving tecovirimat heal more quickly and have less pain compared with those taking placebo. Participants will be followed for at least 57 days and will be asked to fill out a symptom diary, do daily skin checks at home and attend virtual and in-person clinic appointments. They also will undergo physical exams and will be asked to provide blood and other bodily fluid samples, including swabbing fluid from their lesions. Data on the safety and efficacy of tecovirimat will be submitted to the FDA. An independent Data and Safety Monitoring Board (DSMB) will monitor participant safety throughout the duration of the study. In addition, any participant in the randomized cohort who progresses to severe disease will be unblinded and given tecovirimat if they were randomized to placebo.

Number of Visits:  6 to 10
Parking:  Free
Reimbursement:  Yes

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