Independent monitoring board recommends early termination of Ebola therapeutics trial in DRC because of favorable results with two of four candidates
August 12, 2019 National Institutes of Health
Colorized scanning electron micrograph of Ebola virus particles (green) both budding and attached to the surface of infected VERO E6 cells (blue). Image captured and color-enhanced at the NIAID Integrated Research Facility in Fort Detrick, Maryland.NIAID/NIH
Since November, 2018, a randomized, controlled trial of four investigational agents (ZMapp, remdesivir, mAb114 and REGN-EB3) for the treatment of patients with Ebola virus disease has been taking place in the Democratic Republic of the Congo (DRC) as part of the emergency response to an ongoing Ebola outbreak in the North Kivu and Ituri Provinces.
The study is co-sponsored and funded by the Institut National de Recherche Biomédicale (INRB) and the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). Carried out by an international research consortium coordinated by the World Health Organization (WHO), the trial had enrolled 681 patients at four Ebola Treatment Centers (ETCs) in Beni, Katwa, Butembo and Mangina. The ETCs have been overseen by staff from the Institut National de Recherche Biomédicale (INRB); the DRC Ministry of Health; and three medical humanitarian organizations: the Alliance for International Medical Action (ALIMA), the International Medical Corps (IMC), and Médecins Sans Frontières (MSF).
As a member of the trial steering committee, Dr. Adam C. Levine, Professor of Emergency Medicine and Director of the Center for Human Rights and Humanitarian Studies at Brown University was providing technical and research expertise for the implementation of this study through the International Medical Corps (IMC).
The trial is monitored by an independent data and safety monitoring board (DSMB) that meets periodically to review interim safety and efficacy data and to make recommendations to the study team and the sponsors. As a result of their Aug. 9, 2019 review, the DSMB recommended that the study be stopped and that all future patients be randomized to receive either REGN-EB3 or mAb114 in what is being considered an extension phase of the study. This recommendation was based on the fact that an early stopping criterion in the protocol had been me by one of the products, REGN-EB3. The preliminary results in 499 study participants indicated that individuals receiving REGN-EB3 or mAb114 had a greater chance of survival compared to participants in the other two arms.