A5418 Study of Tecovirimat for Human Monkeypox Virus (STOMP)Research Question:
Does the drug, tecovirimat, treat human monkeypox virus?
Basic Study Information
Purpose:Location: University of Rochester Infectious Diseases Clinic
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
Participants will be seen at day 57 to assess for possible recrudescence of infection
(i.e., new lesions occurring after initial resolution of disease.
Study Web URL: https://www.stomptpoxx.org/main
Study Reference #: STUDY00007578
Lead Researcher (Principal Investigator)
Study Contact InformationStudy Coordinator: Susan Hulse
Phone: (585) 273-5636
Additional 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
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
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
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