The antiviral drug tecovirimat did not reduce the duration of mpox lesions in children and adults with clade I mpox in the Democratic Republic of Congo (DRC), according to initial research of data from a randomized, placebo-controlled trial. However, the overall mortality of 1. 7% among study participants, regardless of whether they obtained the drug, was well below the mpox mortality of 3. 6% or higher reported among all cases in the Democratic Republic of Congo. This shows that better outcomes can be achieved in other people with mpox when they are hospitalized and high-quality supportive care can be obtained. The trial is sponsored through the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) and co-led in a government-to-government partnership with the National Institute for Biomedical Research (INRB) of the Democratic Republic of the Congo. Further detailed analyses and effects will be published through clinical channels.
These effects are disappointing, however, they provide us with critical uneasiness and a desire to identify other cure seekers for mpox as we continue to investigate the use of tecovirimat in other mpox populations. We remain committed to developing safe and effective interventions, adding remedies and vaccines, that can alleviate the devastating burden of mpox in Central Africa and combat the milder form of the virus circulating around the world.
Mpox has been provided in West, Central, and East Africa for decades, with the first human case being known in 1970. There are two known types of viruses that cause mpox. Clade I, studied in this trial, is endemic to central Africa and can cause severe disease. Clade II, endemic to West Africa, tends to cause milder illnesses. A clade II virus subtype caused a global outbreak of mox in 2022. People with weakened immune systems, children, and other pregnant people are especially vulnerable to severe mpox. , regardless of the clade of the virus.
Reports of the Impox clade are spreading in Central African countries, specifically in the Democratic Republic of Congo. A recent report from the Centers for Disease Control and Prevention (CDC) indicated that 67% of suspected mpox cases in the Democratic Republic of Congo and 78% of suspected mpox deaths occurred in people aged 15 and under. Tecovirimat, also known as TPOXX, was first developed and approved through the Food and Drug Administration to treat smallpox, a virus very similar, but much more severe, to mpox; However, the protection and efficacy of the drug as a remedy for mpox have not been established. It is currently available for mpox treatment in the United States as part of an independent NIAID-sponsored trial called STOMP and through a CDC Expanded Access to Investigational New Drugs (EA-IND) application process. Tecovirimat is legal in Europe and the United Kingdom for the treatment of smallpox, mpox, and other indications.
In October 2022, NIAID and INRB initiated the PALM007 trial to learn about the protection and efficacy of tecovirimat for the treatment of mpox in adults and children. The study recruited an additional 597 people with laboratory-confirmed mpox at two sites in the Democratic Republic of Congo. Study participants were randomly assigned to receive either tecovirimat or placebo and were admitted to the hospital for at least 14 days, where they were closely monitored for protection and resolution of mpox lesions. All participants obtained supportive care, adding nutrition, hydration, and treatment of secondary infections.
Tecovirimat well tolerated with no serious drug-related adverse events. Overall, mortality decreases and injuries resolve faster than expected, regardless of whether players won tecovirimat or placebo. Study players are informed about the initial effects and presented with the opportunity to participate in an ongoing process. Extension exam that offers additional supportive medical care. Additional analyses are planned to better perceive the results observed in the exam, adding whether there were significant differences in clinical outcomes based on days of symptoms prior to enrollment, clinical disease severity, player characteristics, or genetics. Variant of mpox being treated.
“This study provided urgent evidence to evaluate the reaction to mpox in Central Africa,” said co-principal investigator Jean-Jacques Muyembe-Tamfum, M. D. , Ph. D. , director general of the INRB and professor of microbiology. at the Faculty of Medicine of the University of Kinshasa. Kinshasa, Democratic Republic of the Congo. “Although not what we expected, the results show that the doctors in the study provided exceptional supportive care to all participants, which is a testament to the wisdom and skills that Congolese doctors have acquired in managing diseases related to the mpox.
“The PALM007 study demonstrated the importance and cost of testing experimental mpox treatments through physically potent clinical trials in the endemic context of the Democratic Republic of the Congo,” said Lori Dodd, Ph. D. , PALM task manager for the NIAID for the Democratic Republic of the Congo. “We will continue to compare trials to learn whether additional studies of tecovirimat in patient subgroups are warranted. “
The PALM007 trial is led by co-principal investigators Prof. Muyembe-Tamfum and Placide Mbala, M. D. , Ph. D. , Operations Manager of the PALM Clinical Research Partnership and Head of the Department of Epidemiology and Global Health and the Pathogen Genomics Laboratory at INRB. Véronique Nussenblatt, M. D. , and Olivier Tshiani, M. D. Leidos Biomedical Research at NIAID were co-chairs of the protocol. The trial was implemented in Tunda (Maniema Province) and Kole (Sankuru Province) with Congolese staff, Mitchell Group and NIH’s Frederick National Laboratory for Cancer Research. The collaborating establishments are the US CDC, the Antwerp Institute of Tropical Medicine (MIT), the humanitarian organization Alliance for International Medical Action (ALIMA) and the World Health Organization (WHO). The U. S. Embassy of the United States in the Democratic Republic of the Congo and the U. S. CDC Staff Corps. The U. S. Department of Homeland Security founded in the Democratic Republic of Congo handled logistics and operations for shipping, travel, and regional security. SIGA Technologies, Inc. , founded in New York, provided the tecovirimat for the study.
The Pamoja Tulinde Maisha clinical trials association or “PALM” was established in reaction to the 2018 Ebola outbreak in the Democratic Republic of Congo. The collaboration continued as a multilateral clinical trials program formed by NIAID, the Ministry of Health of the Democratic Republic of the Congo, INRB, and their partners.
NIAID and INRB thank the regular team of Americans who conducted this study in remote areas of the Democratic Republic of the Congo, the members of the study’s independent Data Monitoring and Safety Committee, and most importantly, the study participants and their families. For more information on PALM007, please make a stopover in ClinicalTrials. gov using the NCT05559099 exam ID.
“Given the differences in the populations affected by the two clades of mpox, the types of clinical diseases that arise, and the continued spread of either clades, it is very important that we continue with the STOMP trial and other similar studies, so that we can scale up treatments. . who gain advantages for all other people with mpox,” Dr. Marrazzo said.
The foreign STOMP trial is examining the protection and efficacy of tecovirimat against clade II mpox. To learn more about the STOMP trial, visit ClinicalTrials. gov with the study ID NCT05534984. Another study, UNITY, sponsored by ANRS Emerging Infectious Disease, is comparing tecovirimat with a study design similar to that of STOMP in Argentina, Brazil, and Switzerland. More information about the UNITY study can also be found in ClinicalTrials. gov with ID NCT05597735. Both studies will continue to recruit participants and work largely together. .
NIH/National Institute of Allergy and Infectious Diseases
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