UNMC will be among more than 60 institutions nationwide participating in STOMP (Study of Tecovirimat for Human Monkeypox Virus), a phase 3 trial evaluating the safety and efficacy of the drug tecovirimat for the treatment of human monkeypox.
“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,” said Mark Rupp, MD, chief of the UNMC Division of Infectious Diseases. “I am very pleased and proud of the work being done by the ID faculty and staff at the Nebraska Medicine Specialty Care Center to get this clinical trial up and running. It is but another example of how UNMC ID is on the forefront of treating new and emerging infections.”
STOMP, which is being led by the AIDS Clinical Trials Group (ACTG), has been designed to learn as much as possible in a broad population of people with monkeypox. See information about enrollment in the study.
“UNMC has been caring for patients with monkeypox, and we are thrilled to have been selected as a site for this trial,” said Sara Bares, MD, associate professor in the UNMC Division of Infectious Diseases. “Our expertise in treating highly infectious diseases and in conducting clinical trials will help ensure the success of this trial.”
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.
This multi-center trial will enroll more than 500 adults with monkeypox virus infection. Importantly, this trial will include people with severe disease and those at high risk of severe disease, including pregnant and breastfeeding people, children and individuals with underlying immune deficiency and active inflammatory skin conditions who will receive open-label tecovirimat.
“The ACTG has designed this study to give us the greatest possible insights into whether and how tecovirimat works against monkeypox, including whether the virus develops resistance to the treatment,” said ACTG chair Judith Currier, MD, University of California, Los Angeles. “An important part of that design is the inclusion of children and pregnant people. The study will also evaluate markers that may tell us that the drug is working so we can identify future promising drugs. 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 Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds the ACTG. A list of participating sites in the United States can be found here.
STOMP is led by Timothy Wilkin, MD, Weill Cornell Medicine, William Fischer, MD, University of North Carolina (UNC) and Jason Zucker, MD, Columbia University (vice-chairs), and is supported by Dr. Currier and Joseph J. Eron, MD, UNC (ACTG co-chair).
For more information about STOMP, please visit the ACTG website.