UC San Diego is participating in a national study to evaluate the potential treatment for monkeypox in humans

UC San Diego is participating in a national study to evaluate the potential treatment for monkeypox in humans

The University of California San Diego will be one of several sites evaluating the safety and effectiveness of Tecovirimat as a potential treatment for human monkeypox. Tecovirimat, marketed as TPOXX, is an antiviral drug currently approved for the treatment of human smallpox in adults and children caused by variola virus.

The Tecovirimat for Human Monkeypox Virus (STOMP) trial is a Phase III, randomized, double-blind, placebo-controlled trial funded by the National Institute of Allergy and Infectious Diseases and led by the AIDS Clinical Trial Group (ACTG), the world's largest and longest-running HIV clinical trial network. The AntiViral Research Center (AVRC) at UC San Diego School of Medicine is part of ACTG.

There is an urgent need for MPOX treatments and this study will help us determine whether tecovirimat should be one of them. People living in the San Diego area who have confirmed or probable Mpox have the opportunity to make a significant impact by participating in this study.”

Susan Little, MD, professor of medicine at UC San Diego School of Medicine and infectious disease specialist at UC San Diego Health, co-director of AVRC and principal investigator of the STOMP trial at the UC San Diego site

The current monkeypox, or MPOX, outbreak occurred in the spring of 2022 and has since spread around the world, with more than 75,000 cases in 109 countries and more than 28,000 cases in the United States. San Diego County has documented 440 cases as of October 22nd.

MPOX was first identified in 1958 and has caused increasing numbers of infections annually in endemic countries, mainly in parts of Africa. The current outbreak is primarily characterized by increased person-to-person transmission. Close contact during sexual activity is believed to play a major role in the current outbreak. While most cases have been reported in men who have sex with men, women, children and men who have sex with women have also been infected. There are currently no approved therapies to treat MPOX in humans.

TPOXX is approved by the US Food and Drug Administration to treat smallpox, but its safety and effectiveness against MPOX are unknown. The MPOX virus belongs to the same family of viruses as the Variola virus. MPOX symptoms are similar to smallpox symptoms but milder, and MPOX is rarely fatal. MPOX is not related to chickenpox.

The new study, with more than 60 sites, will enroll more than 500 adults with MPOX virus infections. The study will enroll people with severe disease and those at high risk of severe disease, including pregnant and breastfeeding people, children and people with underlying immunodeficiency and active inflammatory skin diseases, who will receive open-label tecovirimat.

Study participants with symptomatic MPOX virus infection who do not meet the criteria for the open-label cohort will be randomly assigned in a 2:1 ratio to either tecovirimat or placebo orally for 14 days.

Participants randomized to the double-blind cohort who later develop severe disease will be offered the option to switch to open-label Tecovirimat, as will participants who report persistent severe pain due to MPOX virus infection.

All STOMP participants will be followed for at least eight weeks through a combination of virtual and in-person visits and daily self-reports to determine whether patients receiving tecovirimat heal faster than those receiving placebo. STOMP will also provide important data on the optimal dosage and safety of tecovirimat in children and pregnant or breastfeeding individuals.

People with suspected or confirmed MPOX infections (positive tests within seven days) and who experience symptoms within 13 days are eligible to participate. The test is carried out through the study. Participants with suspected MPOX who have not yet been tested may enroll as long as their study-provided test is positive. Participants must also have at least one active skin lesion that has not yet scabbed over, a lesion in the mouth, or proctitis (inflammation of the lining of the rectum).

“The ACTG designed this study to give us the greatest insight possible into whether and how tecovirimat works against monkeypox, including whether the virus develops resistance to the treatment,” said ACTG Chair Judith Currier, MD, professor of medicine at the UCLA David Geffen School of Medicine.

"An important part of this design is the inclusion of children and pregnant women. The study will also evaluate markers that can tell us that the drug is working so that we can identify future promising drugs. Beyond treating the current outbreak, this study has the potential to broadly inform the treatment of people who become infected with monkeypox virus in endemic countries."

Source:

University of California – San Diego

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