WHO launches PARTNERS clinical trial for Bundibugyo virus treatments

In a major international effort to evaluate potential treatments for Ebola disease due to Bundibugyo virus (BVD), the PARTNERS clinical trial has opened enrolment today for patients in the Democratic Republic of the Congo.

The PARTNERS (Platform Adaptive Randomized Trial for New and Repurposed Filovirus TreatmentS) trial will assess whether two antiviral therapies – a monoclonal antibody (MBP134) and remdesivir – can improve survival among people diagnosed with BVD. It will also evaluate whether combining the two antivirals provides additional benefits.

The trial, sponsored by the World Health Organization (WHO), has been coordinated by the Institut National de Recherche Biomédicale (INRB) in the Democratic Republic of the Congo, the Institute of Tropical Medicine in Belgium, and the University of Oxford in the United Kingdom, in collaboration with international research, clinical and humanitarian partners, and supported by Africa CDC.

Since the start of the outbreak, over 1400 people have been diagnosed with BVD, nearly 210 people have recovered and nearly 440 people have died of the disease in the Democratic Republic of the Congo. While effective treatments have been developed for Ebola virus disease, none are currently approved for Bundibugyo virus disease, and no treatment has been shown to work across all virus types that cause Ebola diseases.

These treatments were selected for the trial by the WHO Technical Advisory Group after a thorough review of scientific evidence, including preclinical research and safety data, and evidence from previous outbreak responses. People enrolled in the clinical trial will be provided with close support and follow-up for at least 28 days after enrolment.

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. 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."

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General

The trial has been established as a platform trial, which allows for additional treatments to be added as they become available following assessment by the WHO Technical Advisory Group.

"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," said Professor Amanda Rojek, PARTNERS Trial Operations Lead and Associate Professor of Health Emergencies, at the Pandemic Sciences Institute, University of Oxford. "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."

By integrating this trial into clinical care, we are giving patients access to promising investigational treatments while generating the evidence needed to improve care for current and future outbreaks."

Prof. Jean-Jacques Muyembe-Tamfum, Director-General of the Institut National de Recherche Biomédicale (INRB)

The randomized, controlled trial is enrolling patients of any age with confirmed BVD. The participating treatment units will provide patients with early supportive care, including oral or intravenous fluids, electrolyte replacement, oxygen support, blood pressure management, and pain control in line with WHO treatment guidelines.

"In responding to Bundibugyo virus disease, the Democratic Republic of the Congo is demonstrating its strong commitment to science and research," said Dr Samuel Roger Kamba, Minister of Health of the DRC. "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."

The trial is being delivered in partnership with the Ministry of Public Health of the Democratic Republic of the Congo, ALIMA (The Alliance for International Medical Action) and outbreak response teams from Médecins Sans Frontières (MSF). The study data will be regularly reviewed by an independent data and safety monitoring board.

The PARTNERS trial is expected to assess whether monoclonal antibodies and antiviral therapies can improve outcomes for patients with BVD and reduce mortality in affected communities. It is designed to operate seamlessly across multiple outbreaks, providing a sustainable research platform to generate evidence on safe and effective treatments for Ebola and Marburg diseases.