The World Health Organization (WHO) on July 2 launched a clinical trial in DR Congo to test two experimental treatments for Bundibugyo virus disease an Ebola virus strain for which no approved treatment exists. ALSO READ: New equipment to speed up Rwanda’s detection of Ebola, other high-risk infections Known as the Platform Adaptive Randomised Trial for New and Repurposed Filovirus TreatmentS (PARTNERS), the study has opened enrolment for people with confirmed infection. ALSO READ: Rwanda on alert as Ebola outbreak is declared global emergency Scientists will evaluate whether the monoclonal antibody MBP134 and the antiviral drug remdesivir can improve survival, while also determining whether using the two medicines together produces better outcomes than either one alone. WHO is sponsoring the research, which is coordinated by the Institut National de Recherche Biomédicale (INRB) in DR Congo, the Institute of Tropical Medicine in Belgium, and the University of Oxford in the United Kingdom, working alongside international research, clinical, and humanitarian partners with support from the Africa Centres for Disease Control and Prevention (Africa CDC). The initiative comes as DR Congo responds to an outbreak that has infected more than 1,400 people. According to WHO, nearly 210 have recovered, while close to 440 have died. Although therapies have been developed for some forms of Ebola virus disease, none have been approved for Bundibugyo disease, and no medicine has yet been shown to work against all Ebola virus species. WHO said MBP134 and remdesivir were selected by its Technical Advisory Group after a review of laboratory studies, safety data, and evidence gathered during previous Ebola outbreaks. Everyone enrolled will be closely monitored for at least 28 days. “Even without approved therapeutics, people are recovering from this disease, but of course, we could save many more lives with safe and effective therapeutics in our toolkit,” said WHO director general Tedros Adhanom Ghebreyesus. “The PARTNERS trial, established with national authorities and scientific partners in record time, offers hope that we can deliver concrete results for, and with, the communities at the heart of the outbreak,” he added. The platform has been designed so that additional medicines can be included if they show promise and are recommended by the WHO’s Technical Advisory Group. “We urgently need treatments that can help people affected by Bundibugyo virus disease,” said Amanda Rojek, a clinical researcher specialising in health emergencies. “One of the key lessons from recent outbreaks is that research needs to happen alongside the response, not after it.” She added that the PARTNERS trial allows evaluating potential treatments during the outbreak itself, so that the evidence generated can help inform patient care when it is needed most, in months rather than years. Jean-Jacques Muyembe-Tamfum, the Director-General of the Institut National de Recherche Biomédicale (INRB), said incorporating the study into routine patient care gives participants access to promising investigational medicines and generating evidence that could improve the management of future outbreaks. People of all ages with confirmed infection are eligible to participate. In addition to the investigational medicines, participating treatment centres will provide supportive care, including oral or intravenous fluids, electrolyte replacement, oxygen therapy, blood pressure management, and pain relief, in line with WHO treatment guidelines. Tags:
