Clinical Safety Office supports patient safety monitoring for mpox clinical trial in Africa

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A new clinical study in Africa is testing an antiviral treatment for patients with mpox (previously known as monkeypox). This is the latest project for the Frederick National Laboratory for Cancer Research’s Clinical Monitoring Research Program, which specializes in supporting clinical trials in domestic and international settings.   

The Clinical Safety Office, under the leadership of physician Marc Teitelbaum, within the Clinical Monitoring Research Program supports its safety counterparts on the ground in the Democratic Republic of the Congo (DRC) for the study co-sponsored by the DRC’s National Institute for Biomedical Research and the National Institute of Allergy and Infectious Diseases.   

It is familiar territory for Teitelbaum and team, as they served the same role with the same Congolese colleagues in the 2018-2019 PALM001 trial, also conducted in the DRC, that led to two FDA-approved treatments for Ebola virus disease. PALM is the acronym for “Pamoja Tulinde Maisha,” which means “together save lives” in Swahili. Their experience with Congolese safety officials on the original PALM trial paved the way for a rapid set-up of the mpox trial, known as PALM 007. FNL CMRP physician Adam Schechner co-leads with his DRC counterpart the clinical safety program team for PALM 007.  

As they did for the Ebola clinical trial, the FNL team supports its DRC counterparts in monitoring and reporting to help ensure safety of the participants. They review the protocol for regulatory purposes, monitor safety events, and help the DRC safety team address any issues that occur. The team acts in collaboration with the NIAID Data and Safety Monitoring Board, ensuring the safety data being gathered is of sufficient quality and detail so it can potentially support eventual approval of the treatment.   

“In the PALM001 trial, our colleagues in the DRC developed a robust safety and pharmacovigilance program. With PALM007, they are improving and refining it,” Teitelbaum said.     

For the mpox study, the FNL CMRPD safety team continues to mentor and advise their long-time Congolese colleagues on regulatory reporting requirements and compliance. “Having that prior relationship and structure already in place really helped to speed things along,” Schechner said.  

Addressing the mpox outbreak  

Mpox is often present, or endemic, in several African countries, where the disease is mainly thought to be spread through close personal contact. Outside of Africa, the worldwide outbreak in 2022 was primarily among men who have sex with men, Schechner said.  

People with mpox develop a skin rash or mucosal lesions which can last two to four weeks accompanied by fever, headache, muscle aches, back pain, low energy, and swollen lymph nodes.    

With a mortality rate of 5 to 10 percent in the DRC, mpox is not nearly as contagious nor as deadly as Ebola, which according to the U.S. Centers for Disease Control, is lethal to upwards of 50 percent of people infected. The study seeks to enroll 450 people at sites in the DRC cities of Tunda and Kole. Study treatment is a 14-day course of either an oral antiviral drug called tecovirimat or a placebo. 

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Helping with logistics to facilitate remote clinical study 

Tunda and Kole are in remote locations with poor transportation access. It can take study participants hours or days to travel to the study sites. Heavy precipitation during the rainy season of November to March can also wash out bridges and roads,thus reducing access to this region.     

An existing health center was renovated to add an inpatient treatment facility for the trial. Colleagues including Kevin Newell, clinical project manager within the Clinical Research Monitoring Program, also arranged for workers on the ground to install satellite communications for data transmission and extra batteries to provide backup to the spotty power supply.  

All study participants must have a laboratory-confirmed positive test for mpox and respond to study inclusion criteria to be enrolled. They stay in the hospital for at least 14 days.