Help Scientists Find a Safe and Effective Mpox Treatment

Summary: The STOMP trial is evaluating the antiviral drug tecovirimat (TPOXX) as a treatment for mpox. Learn how individuals, providers, and community organizations can get involved.

Since the peak of a global mpox outbreak in the summer of 2022, infections have thankfully decreased. Yet mpox remains a public health threat, and no treatment has been proven safe and effective for people experiencing mpox disease. However, scientists are on the case—and you may be able to help!

The STOMP Trial

A study titled, “A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Virus Disease,” or STOMP trial, is evaluating the antiviral drug tecovirimat (also known as TPOXX) as a treatment for mpox. TPOXX is approved by the FDA to treat smallpox, but its safety and efficacy against mpox is unknown. That’s why the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring this study—to gain insights on whether the drug works to treat mpox and help prepare for future outbreaks. STOMP is the primary method of accessing TPOXX for mpox for most people in the United States because the study setting allows healthcare providers to monitor people’s health closely and collect the data required to ultimately determine the drug’s safety and efficacy.

Here’s how the study works:

• Participants with mild to moderate mpox are randomly assigned in a 2:1 ratio to receive the drug TPOXX or a placebo for 14 days. Neither researchers nor study participants know which arm they’re enrolled in.
• People who are at higher risk for severe disease because of their age or medical history are assigned to receive open-label TPOXX for 14 days. Open label means both participants and study staff are aware the participants are receiving TPOXX.
• All participants are followed for about 2 months, through in-person and/or video appointments, questionnaires, and symptom diaries.

People who have been diagnosed with mpox or are presumed to have mpox can enroll in the STOMP trial now. The trial is all-inclusive, enrolling adults and children of all races and sexes, people with HIV, and pregnant and lactating people across more than 60 sites in the United States and other countries, with an option for remote enrollment from other U.S. locations—all with the goal of gathering enough information so that if this drug is proven to be safe and effective, researchers know it works for the entire population.

Why Is the STOMP Trial So Important?

People who get mpox deserve a treatment that works! Research studies are the only way to make sure a medicine works well, and to get government approval for its continued use and better availability. The STOMP trial is a key component of the U.S. public health response to mpox.

VIDEO: Dr. Cyrus Javan, Medical Officer in NIH's National Institute of Allergy and Infectious Diseases (NIAID), explains the importance of the STOMP trial (audio description version here).

How You Can Help

• If you’re an individual who has a positive mpox test result or think you might have mpox: Call the Mpox Study Hotline (855) 876-9997.Representatives will help you find a study site near you. A study site can be in person or 100% remote/virtual with video.

• If you’re a healthcare provider: Order/collect human mpox virus PCR testing. A positive test result is requested for continued participation following enrollment. Or, you can enroll your patient in person with a presumptive diagnosis and the research site can perform the test.Call the mpox study hotline (855) 876-9997 together with your patient or provide the number directly to your patient.

• If you’re a community organization: Spread the word about the STOMP trial. Encourage people in your community to get involved so that the participant pool is as diverse as possible. Learn more about the STOMP trial at STOMPTPOXX.org.

Stay Healthy! Get the Mpox Vaccine.

If you haven’t already been vaccinated against mpox, now is the time! CDC recommends that people with HIV and others at risk for mpox get vaccinated with both doses of the two-dose JYNNEOS vaccine. If you’ve only had one dose, get the second. Two doses provide the best protection. Talk to your provider about whether the mpox vaccine is right for you.