A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease: Study of Tecovirimat for Human Monkeypox Virus (STOMP). A Multicenter Trial of the AIDS Clinical Trials Group (ACTG)
Study of Tecovirimat for Human Monkeypox Virus (STOMP)
Sponsor: NIH
Enrolling: Male and Female Patients
IRB Number: AAAU1606
U.S. Govt. ID: NCT01946139
Contact: Nora Howell: 917-841-4125 / hpcresearch@cumc.columbia.edu
Additional Study Information: We are looking for adult volunteers with presumed or confirmed monkeypox infections to help us see if tecovirimat (TPOXX) is a safe and effective treatment for monkeypox. Human Monkeypox Virus is currently the cause of an outbreak in the US and throughout the world, leading the World Health Organization to declare it a public health emergency of international concern. Tecovirimat, an oral medication that is FDA-approved to treat smallpox, is thought to have activity against monkeypox, based on small studies in animals and humans. This study will assess the safety and effectiveness of tecovirimat in treating monkeypox infections in adults with presumed or confirmed monkeypox infections. The study will include a placebo arm; approximately 530 participants will be randomly assigned in a 2:1 ratio to receive tecovirimat pills (Arm A of the study) or matching placebo pills (Arm B) for 14 days. An additional approximately 250 individuals who meet specific study criteria (including study-defined severe disease or severe immunosuppression) will be given open-label tecovirimat (Arm C). Participants in Arms A and B who have severe pain after 5 days of treatment, or who progress to the study-defined severe disease will be offered open-label tecovirimat. Participants will have weekly follow-up visits for the first four weeks, and then one final study visit at day 57. Individuals who join the study will be compensated for their time for in-person study visits. If you have suspected or confirmed monkeypox, you may be eligible to participate. Not sure if you are eligible? Take the first step and request to be contacted by our study team.
Sharon Mannheimer, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Do you currently have symptoms of monkey pox infection? (Such as fever and pustular skin lesions) Yes No
Did your symptoms start more than 14 days ago? Yes No
Have you taken any tecovirimat (TPOXX) pills - (a prescribed experimental medication for monkeypox)? Yes No
You may be eligible for this study

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For more information, please contact:
Nora Howell