Washington Medical University researchers are recruiting participants for a phase 3 clinical trial of a drug to treat monkeypox virus. tecovirimat is approved by the U.S. Food and Drug Administration for the treatment of smallpox. The investigators hope this study will determine whether the drug is also safe and effective for treating monkeypox.
Treatments for monkeypox are urgently needed, and this study will help us gain important information about the safety and efficacy of tekovirimat in treating this infection. People who live in the Seattle area who have monkeypox have the opportunity to make a significant contribution by participating in this study.”
Dr. Rachel Bender Ignacio, MD, Scientist, and Assistant Professor of Allergy and Infectious Diseases at the University of Washington School of Medicine
Those wishing to register should contact UW Positive Research, formerly the AIDS Clinical Trials Unit, by email ([email protected]) or audio/text (206-773-7129).
Monkeypox has caused an increasing number of infections in endemic countries since the virus was first identified in 1958. A global outbreak emerged early this year and has since spread around the world, currently totaling more than 60,000 cases in 103 countries. , including more than 23,000 cases in the USA.
The outbreak was marked by increased person-to-person transmission, and close contact during sexual activity is thought to play an important role. Most cases have so far been reported among men who have sex with men, but women and children have also been affected. There are currently no approved treatments for human monkeypox.
This multicenter trial aims to enroll more than 500 adults with monkeypox virus infection. This trial will include people who are severely ill and those at risk of serious illness including pregnant and nursing women, children, and individuals with underlying immunodeficiency and active inflammatory skin conditions who will receive open-label tekovirimat.
Individuals who have had either a presumptive or confirmed monkeypox infection (test positive within seven days) and who have experienced symptoms within 14 days are eligible. The test will be provided by the study. Participants with presumed monkeypox virus infection who were not yet tested can enroll if the test provided by the study is positive. Participants must also have at least one active skin lesion that has not yet crusted over, a lesion in the mouth, or proctitis (inflammation of the lining of the rectum).
Study participants with symptomatic monkeypox virus infection who do not meet the criteria for an open-label group will be randomly assigned to receive either tekovirimat or an oral placebo for 14 days. Participants randomized to the double-blind study group who subsequently developed severe disease will be offered the option to switch to open-label tecovirimat, as will participants who reported persistent severe pain from monkeypox virus infection.
All participants will be followed up for at least eight weeks with a combination of virtual, in-person, and daily self-report visits to determine whether those receiving tekovirimat recover more quickly compared to those receiving placebo. The investigators hope that the trial will also provide data on optimal dosing and safety of tekovirimat in children and pregnant and breastfeeding women.
The trial, called STOMP (the Tecovirimat Study of Human Monkey Pox Virus), is being sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH). Led by the AIDS Clinical Trials Group. A list of participating sites can be found in the United States over here. Additional details about STOMP are available in file Press release from the National Institutes of Health.