In a significant international effort to assess potential treatments for Bundibugyo virus disease (BVD), a clinical trial known as PARTNERS has begun enrolling patients in the Democratic Republic of the Congo. The trial aims to determine the effectiveness of two antiviral therapies: a monoclonal antibody (MBP134) and remdesivir.
Trial Goals and Coordination
The PARTNERS (Platform Adaptive Randomised Trial for New and Repurposed Filovirus TreatmentS) trial will evaluate if these treatments can improve survival rates among those affected by BVD. Additionally, it will investigate whether a combination of both antivirals offers further advantages.
This trial, sponsored by the World Health Organization (WHO), is 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, with support from Africa CDC. Collaboration includes international research, clinical, and humanitarian partners.
Current Situation and Need for Treatment
Since the outbreak began, over 1,400 individuals have been diagnosed with BVD in the Democratic Republic of the Congo, resulting in approximately 210 recoveries and 440 deaths. Although treatments for other Ebola virus diseases exist, none are officially approved for Bundibugyo virus disease, and no single treatment has proven effective across all Ebola virus types.
The trial’s treatments were chosen by the WHO Technical Advisory Group after a rigorous review of scientific data, preclinical research, and safety evidence. Participants will receive close monitoring and follow-ups for at least 28 days post-enrolment.
Expert Commentary
Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized that even without approved treatments, people are recovering from BVD. However, he noted that effective therapeutics could save many more lives. He stated, “The PARTNERS trial offers real hope that we can deliver concrete results for the communities at the heart of the outbreak.”
Professor Amanda Rojek, PARTNERS Trial Operations Lead, highlighted the urgency of integrating research with outbreak responses. “The PARTNERS trial enables us to evaluate potential treatments during the outbreak, providing evidence that can inform patient care in months rather than years,” she remarked.
Prof. Jean-Jacques Muyembe-Tamfum, Director-General of INRB, added, “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.”
Trial Design and Partners
The trial will enroll patients of all ages with confirmed BVD diagnoses. Participating medical units will provide supportive care, including fluids, electrolyte replacement, oxygen therapy, and pain management according to WHO guidelines.
Dr. Samuel Roger Kamba, Minister of Health of the DRC, expressed optimism, stating that the trial represents a significant step forward and offers hope for patients and communities affected by BVD.
The trial involves partnerships with the Ministry of Public Health of the Democratic Republic of the Congo, ALIMA, and outbreak response teams from Médecins Sans Frontières (MSF). An independent data and safety monitoring board will review the study data regularly.
The trial aims to determine the impact of monoclonal antibodies and antiviral therapies on patient outcomes and mortality rates in BVD-affected communities. It is designed to facilitate ongoing research across multiple outbreaks, ensuring a sustainable platform for evaluating treatments for Ebola and Marburg diseases.
For any medical concerns or participation considerations, please consult a healthcare professional.
