The safety and efficacy of investigational Ebola medicines in multiple countries experiencing outbreaks will be evaluated internationally.
Ebola is a deadly infectious disease with no currently approved treatments. Several promising drugs are in development, however, and are being given to some 160 patients under the Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) program established by the World Health Organization (WHO) and the Democratic Republic of the Congo (DRC). These patients have not been part of any clinical study, and therefore the performance of the medicines is not being evaluated in any standard manner.
However, a new clinical trial announced by the WHO's Ministry of Health and the DRC is changing that. The trial is the first multi-outbreak, multi-country study to be performed under a WHO initiative agreed to by international organizations, United Nations partners, countries at risk of Ebola, drug manufacturers and others. The protocol will allow for evaluation of the safety and efficacy of different investigational Ebola treatments through the collection of standardized data. The different drug candidates will be assigned to patients randomly.
This first trial is being coordinated by the WHO and led and sponsored by the DRC’s National Institute for Biomedical Research (INRB), in partnership with the DRC Ministry of Health, the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the United States’ National Institutes of Health, The Alliance for International Medical Action (ALIMA) and other organizations.
