Monkeypox virus, illustration. (Thom Leach/Science Photo Library)
OMAHA — The University of Nebraska Medical Center is among more than 60 sites nationally that has been tapped for a trial study of a monkeypox treatment.
The STOMP (Study of Tecovirimat for Human Monkeypox Virus) is a phase 3 trial evaluating the safety and effectiveness of the antiviral tecovirimat drug.
Dr. Mark Rupp, chief of UNMC’s Infectious Diseases Division, called the medical center’s role an example of being at the forefront of treating emerging infections.
“As we learned in the COVID-19 pandemic, oftentimes the best way to proceed in times of clinical ambiguity is to as quickly as possible conduct a well-designed randomized, controlled trial to assess the efficacy and safety of promising therapeutics,” Rupp said.
A global outbreak of monkeypox emerged this spring, to date including more than 21,000 cases in the U.S. Most cases have been reported among men who have sex with men, but women and children have also been infected.
No therapies are currently approved to treat human monkeypox.
Dr. Sara Bares, associate professor, noted that UNMC has been caring for patients with monkeypox, and the expertise in treating highly infectious diseases will help ensure the trial’s success.
Tecovirimat is approved by the U.S. Food and Drug Administration to treat smallpox, but it is not yet known if it can effectively or safely treat monkeypox.
More than 500 adults with the monkeypox virus are to be enrolled in the study, which also is to include pregnant and breastfeeding women, children and individuals with immune deficiency and inflammatory skin conditions.
“The study will also evaluate markers that may tell us that the drug is working so we can identify future promising drugs,” said Dr. Judith Currier of the University of California, San Diego. “Beyond addressing the current outbreak, this study has the potential to profoundly inform the treatment of individuals who acquire monkeypox virus in endemic countries.”
STOMP is sponsored by the National Institutes of Health and led by the AIDS Clinical Trials Group, founded in 1987 as the world’s first HIV research network.
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