Study of Tecovirimat for Human Monkeypox Virus (STOMP)
Research Question:
Is the drug, tecovirimat (TPOXX), effective for treating human monkey pox virus disease?
Basic Study Information
Purpose:
Tecorvirimat is an oral medication used to treat monkeypox. Participants are eligible
if they have a laboratory confirmed Monkeypox infection within 7 days of enrollment.
Participants will take either Tecorvirimat or placebo for 14 days. Participants with
severe disease, significant skin conditions, or 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.
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 at
day 57 to assess for possible recrudescence of infection (i.e., new lesions occurring
after initial resolution of disease.
Location: ACTG Research office, ID Clinic, URMC AC-3
Study Web URL: https://www.stomptpoxx.org/main https://www.stomptpoxx.org/main
Study Reference #: 00007578
Lead Researcher (Principal Investigator)
Lead Researcher:
Sonal Munsiff
Study Contact Information
Study Coordinator: Susan Hulse
Phone: (585) 273-5636
Email: susan_hulse@urmc.rochester.edu
Additional Study Details
Study Details:
Those with severe disease or disease progression will be put into the open label arm
of the study rather than taking/continuing possible placebo
Number of Visits:
6 to 10
Parking:
Free
Transportation Coverage:
Reimbursement:
Yes
Learn More About These Conditions
More information about Monkeypox
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