Patient enrolment has begun in the Democratic Republic of the Congo for the PARTNERS clinical trial of treatments for Bundibugyo virus disease (BVD), an international collaboration between the Institut National de Recherche Biomédicale (INRB) Democratic Republic of the Congo, the Institute of Tropical Medicine (ITM), Antwerp, and the University of Oxford.
PARTNERS is delivered through a partnership of Ministries of Health, researchers, healthcare workers and international research and non-governmental organisations (NGOs).
Sponsored by the World Health Organization (WHO), the PARTNERS (Platform Adaptive Randomised Trial for New and Repurposed Filovirus TreatmentS) trial will evaluate potential therapies for Bundibugyo virus disease, which is causing the current outbreak.
Unlike traditional outbreak trials, the innovation behind PARTNERS is that it has been designed before outbreaks occur, allowing research to begin quickly when it is needed most. As a platform trial, it can test several treatments for the same disease at the same time and adapt as new evidence emerges. Instead of creating a new clinical trial for every outbreak, the same system can be used to evaluate different treatments across multiple outbreaks and countries.
“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 Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “The PARTNERS trial, established with national authorities and scientific partners in record time, offers real hope that we can deliver concrete results for – and with – the communities at the heart of the outbreak.”
The products being evaluated initially are the monoclonal antibody MBP134, provided by Mapp Biopharmaceutical, and remdesivir, provided by Gilead Sciences. The trial will determine whether the investigational therapies, either alone or in combination, improve survival among people diagnosed with Bundibugyo virus disease.
Professor Amanda Rojek, PARTNERS International Principal Investigator and Associate Professor of Health Emergencies at PSI, said: "We urgently need treatments that can help people affected by Bundibugyo virus disease. One of the key lessons from recent outbreaks is that research needs to happen alongside the response, not after it. The PARTNERS trial gives us an opportunity to evaluate 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."
Since the current outbreak began in the Democratic Republic of the Congo (DRC), over 1400 people have been diagnosed with BVD, nearly 210 people have recovered, and over 440 people have died of the disease in the DRC.
The trial is being delivered with the Ministry of Public Health of the Democratic Republic of the Congo. Dr Samuel Roger Kamba, Minister of Health of the DRC said: “In responding to the Bundibugyo virus disease, the Democratic Republic of the Congo is demonstrating its strong commitment to science and research. The launch of the PARTNERS clinical trial represents a significant step forward, offering renewed hope to patients, their families, and affected communities. Findings from this study could contribute to identifying more effective therapeutic options, helping to save lives during the current outbreak while strengthening global preparedness for future Ebola epidemics.”
Professor Jean-Jacques Muyembe of Institut National de Recherche Biomédicale (INRB) added “By integrating this clinical trial into clinical care, we are giving patients access to promising investigational treatments while generating the evidence needed to improve care for future outbreaks."
Professor Laurens Liesenborghs, International Principal Investigator at the Institute of Tropical Medicine (ITM), Antwerp, said: "For people and families affected by the current outbreak, the trial offers the first opportunity to determine whether treatments can improve survival for Bundibugyo virus disease. Establishing this trial during the outbreak gives us the best opportunity to generate the clinical evidence that can guide treatment decisions and ultimately save lives."
The rapid launch of the trial has been made possible through long-term investment from the Wellcome, the UK Foreign, Commonwealth & Development Office (FCDO), and the Medical Research Council (MRC), part of UK Research and Innovation (UKRI). Their support has enabled the PARTNERS partnership to be established ahead of outbreaks, building the scientific collaborations, operational readiness and research infrastructure needed to rapidly evaluate new treatments when outbreaks occur.
More information about the PARTNERS trial is available at https://partnerstrial.ndm.ox.ac.uk/