A clinical trial has begun in the Democratic Republic of the Congo (DRC) to evaluate the effectiveness of the antiviral drug tecovirimat (also known as TPOXX) in adults and children with monkeypox. The trial will assess the safety of the drug and its ability to reduce monkeypox symptoms and prevent serious consequences, including death. Under the PALM intergovernmental partnership, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the National Institute for Biomedical Research (INRB) of the Democratic Republic of the Congo are co-leading the study. . Collaborating agencies include the US Centers for Disease Control and Prevention (CDC), the Antwerp Institute of Tropical Medicine, the International Alliance of Health Organizations (ALIMA), and the World Health Organization (WHO).
Produced by pharmaceutical company SIGA Technologies, Inc. (New York), TPOXX is FDA approved for smallpox. The drug stops the spread of the virus in the body, preventing the release of viral particles from the cells of the body. The drug targets a protein found in both the smallpox virus and the monkeypox virus.
“Monkeypox causes a significant burden of illness and death among children and adults in the Democratic Republic of the Congo, and improved treatment options are urgently needed,” said NIAID Director Anthony S. Fauci, MD. The effectiveness of the treatment of monkeypox. I would like to thank our scientific partners from the DRC and the Congolese for their continued collaboration in advancing this important clinical research. ”
Monkeypox virus has caused sporadic cases and outbreaks since the 1970s, mostly in the rainforest regions of Central and West Africa. Since May 2022, multicontinental outbreaks of monkeypox have continued in areas where the disease is not yet endemic, including Europe and the United States, with the majority of cases occurring in men who have sex with men. The outbreak prompted the World Health Organization and the US Department of Health and Human Services to recently declare a public health emergency. From January 1, 2022 to October 5, 2022, WHO reported 68,900 confirmed cases and 25 deaths in 106 countries, territories and territories.
According to the World Health Organization, the cases identified as part of an ongoing global outbreak are mainly caused by the Clade IIb monkeypox virus. Clade I is estimated to cause more severe disease and higher mortality, especially in children, than clade IIa and clade IIb, and is the cause of infection in the Democratic Republic of the Congo. From January 1, 2022 to September 21, 2022, the African Centers for Disease Control and Prevention (Africa CDC) reported 3,326 cases of monkeypox (165 confirmed; 3,161 suspected) and 120 deaths.
Humans can contract monkeypox through contact with infected animals such as rodents, non-human primates, or humans. The virus can be transmitted between people through direct contact with skin lesions, bodily fluids and airborne droplets, including close and sexual contact, as well as indirect contact with contaminated clothing or bedding. Monkeypox can cause flu-like symptoms and painful skin lesions. Complications can include dehydration, bacterial infection, pneumonia, inflammation of the brain, sepsis, eye infection, and death.
The trial will involve up to 450 adults and children with laboratory-confirmed monkeypox infection weighing at least 3 kg. Pregnant women are also eligible. Volunteer participants will be randomly assigned to take tecovirimat or placebo capsules orally twice daily for 14 days at a dose that depends on the weight of the participant. The study was double-blind, so participants and researchers did not know who would receive tecovirimat or placebo.
All participants will remain in the hospital for at least 14 days where they will receive supportive care. Investigator physicians will regularly monitor participants’ clinical condition throughout the study and will ask participants to provide blood samples, throat swabs, and skin lesions for laboratory evaluation. The main aim of the study was to compare the mean time to healing of skin lesions in patients treated with tecovirimat versus placebo. The researchers will also collect data on a number of secondary goals, including comparing how quickly participants tested negative for monkeypox virus in their blood, the overall severity and duration of the illness, and mortality between groups.
The participants were discharged from the hospital after all of the lesions had crusted or peeled off and had tested negative for monkeypox virus in their blood for two consecutive days. They will be observed for at least 28 days and will be asked to return in 58 days for an optional exploratory visit for additional clinical and laboratory tests. An independent data and safety monitoring committee will monitor the safety of participants throughout the study period.
The study was led by co-principal investigator Jean-Jacques Muyembe-Tamfum, Director General of INRB and Professor of Microbiology, Faculty of Medicine, University of Kinshasa, Gombe, Kinshasa; Placid Mbala, MD, PALM Program Manager, Head of the INRB Epidemiology Division and the Pathogen Genomics Laboratory.
“I am glad that monkeypox is no longer a neglected disease and that soon, thanks to this study, we will be able to demonstrate that there is an effective treatment for this disease,” said Dr. Muyembe-Tamfum.
For more information, visit Clinicaltrials.gov and search for ID NCT05559099. The test schedule will depend on the registration rate. The NIAID-supported TPOXX trial is underway in the United States. For information about US trials, visit the AIDS Clinical Trials Group (ACTG) website and search for TPOXX or study A5418.
PALM is an acronym for “Pamoja Tulinde Maisha”, a Swahili phrase that means “saving lives together”. NIAID established a PALM clinical research partnership with the DRC Ministry of Health in response to the 2018 Ebola outbreak in eastern DRC. The collaboration continues as a multilateral clinical research program consisting of NIAID, DRC Health Department, INRB and INRB partners. The first PALM study was a randomized controlled trial of multiple treatments for Ebola virus disease that supported regulatory approval of NIAID-developed mAb114 (Ebanga) and REGN-EB3 (Inmazeb, developed by Regeneron).
NIAID conducts and supports research at NIH, the United States, and around the world to understand the causes of infectious and immune-mediated diseases and develop better ways to prevent, diagnose, and treat these diseases. Press releases, newsletters, and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): The National Institutes of Health (NIH) is a United States medical research institution of 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, investigating the causes, treatments, and treatments for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
Post time: Oct-14-2022
