US Clinical Trial Begins to Evaluate Monkeypox Antiviral Properties

news release

Friday, September 9, 2022

An NIH trial to collect data on tecovirimat (TPOXX).

A Phase 3 clinical trial evaluating the antiviral drug tecovarimat, also known as TPOXX, is currently enrolling adults and children with monkeypox in the United States. The investigator aims to enroll more than 500 of her from clinical research sites across the country.Interested volunteers can visit ACTG website (clinical study A5418) for more information. The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. funded by NIAID AIDS Clinical Trials Group (ACTG) is leading this research, which may later be expanded to international sites.of Eunice Kennedy Shriver NIH’s National Institute of Child Health and Human Development (NICHD) supports several sites, including through the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT).

Manufactured by New York City pharmaceutical company SIGA Technologies, Inc., Tecovirimat is approved by the U.S. Food and Drug Administration for the treatment of smallpox. By targeting proteins found in both the variola and monkeypox viruses that cause smallpox, the drug prevents virus particles from exiting human cells and prevents the virus from spreading in the body. Clinicians are currently Expanded Access or “Considerate Use”” request process.

“Monkeypox can be a very painful infection that can last for weeks,” said Anthony S. Fauci, M.D., director of the NIAID. This clinical trial was designed to answer these important questions. “

The global outbreak of human monkeypox virus, first identified in May 2022, led to the declaration of a public health emergency by both the World Health Organization (WHO) and the U.S. Department of Health and Human Services this summer. rice field. The majority of confirmed cases so far have been men who have had sex with men, but other populations, including women and children, can be infected.January 1, 2022 to September 7, 2022 To date, WHO has reported 52,996 cases and 18 deaths in 102 countries, territories and territories. The Centers for Disease Control and Prevention has reported 21,504 cases in the United States.

Before pandemics, monkeypox cases and epidemics were mostly confined to countries in Central and West Africa, where the virus is endemic. Monkeypox can cause flu-like symptoms and painful skin lesions. In rare cases, monkeypox virus can cause serious complications such as dehydration, bacterial infections, pneumonia, brain inflammation, sepsis, eye infections, and death. The virus can be spread from person to person through direct contact, especially sexual contact, with skin lesions, body fluids, and respiratory droplets, and through indirect contact with items such as contaminated clothing and bedding. It can be contagious. Preliminary analysis indicates that sexual transmission may play a role in the current outbreak.

Clinical trials of tecovirimato in the United States are being led by Timothy Wilkin, M.D., Ph.D., professor of medicine at Weill Cornell Medicine in New York City. Adults and children of all ages with monkeypox are eligible to enroll in the study. Adults with severe monkeypox virus infection or those at increased risk for serious illness, including individuals with underlying immunocompromised, pre-existing or active inflammatory skin disease, pregnant persons, and children All, all participants will be enrolled in an open-label arm receiving tecovirimato. Other adult participants (530 total) will be randomly assigned in a 2:1 ratio to receive tecovirimat or placebo tablets. Tecovirimat capsules were taken orally for her 14 days and the dosage was based on the participant’s weight. This part of the trial is double-blind. That is, neither participants nor researchers know who is receiving placebo or tecovirimato.

The investigator will collect data to determine whether participants receiving tecovalimat heal faster than those receiving placebo (all lesions crusted). or peel off). They will also examine the impact of tecovalimat on pain scores, rates of progression to critical disease, clearance of monkeypox virus from various samples, and its safety, among other data. This study also provides important data on the optimal dosage and safety of tecovirimato in children and pregnant persons.

Participants will be followed for at least 8 weeks, asked to complete a symptom diary, perform daily skin checks at home, and attend virtual and in-person clinic appointments. You will be asked to provide blood and other bodily fluid samples, including swab fluid.

Data on the safety and efficacy of tecovirimat will be submitted to the FDA. An independent Data and Safety Monitoring Board (DSMB) will monitor participant safety for the duration of the study. The trial timeline depends on the pace of enrollment. This work is supported through his NIAID grants: UM1AI068636, UM1AI106701, UM1AI068634, and NICHD contract number HHSN275201800001I.

NIAID is also working with the National Institute of Biomedical Research (INRB) in the Democratic Republic of the Congo to initiate another clinical trial of tecovirimato in adults and children with monkeypox in the country. More information about this study will be available in an upcoming announcement.

NIAID conducts research at the NIH, throughout the United States, and around the world to study the causes of infectious and immune-mediated diseases and to develop better tools to prevent, diagnose, and treat these diseases. and support. News releases, fact sheets, and other NIAID-related materials are available at NIAID website.

About the National Institutes of Health (NIH):NIH, the United States medical research agency, has 27 laboratories and centers and is part of the US Department of Health and Human Services. NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research investigating the causes, treatments, and cures for both common and rare diseases. . For more information about NIH and its programs, visit www.nih.gov.

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