Tuesday, November 27, 2018
An international research team has begun enrolling patients in a clinical trial that evaluates multiple Ebola therapies under investigation in the Democratic Republic of the Congo (DRC). The randomized controlled trial includes patients of any age with confirmed disease of the Ebola virus (EVD) in a treatment unit in the city of Beni operated by ALIMA (The Alliance for International Medical Action), a humanitarian medical organization.
The trial, which will be extended to other districts of the DRC, is organized through an international research consortium coordinated by the World Health Organization (WHO). It is directed and financed by the National Institute of Biomedical Research (INRB), which is part of the Ministry of Health of the DRC, and the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health USA UU Additional international partners.
"The fight against Ebola requires a comprehensive response based on the strengths of all areas of public health. Biomedical research can lead to new critical tools, such as therapies that can save lives, "said NIAID Director Anthony S. Fauci., MD" Through scientifically and ethically sound clinical trials, we hope to establish safety in an efficient and definitive way. and the effectiveness of these Ebola research treatments offer new ways to save lives. "
On August 1, 2018, the Ministry of Health of the Democratic Republic of the Congo declared the tenth outbreak of EVD in the country. As of November 25, 2018, 240 deaths have been reported from 419 confirmed and probable cases of EVD in the north-eastern provinces of North Kivu and Ituri. Under the direction of the Ministry of Health of the DRC, WHO has coordinated the response to the outbreak with several international partners. NIAID, together with the Centers for Disease Control and Prevention of the United States, the United States Agency for International Development (USAID) and other governmental partners of the United States, have provided guidance and support for the multisector response to outbreaks .
"We urgently need safe and effective treatment for this deadly disease," said DRC Health Minister Oly Ilunga Kalenga, M.D., Ph.D. "As we face a 10th Ebola outbreak, we hope this clinical trial will give us more information about the best way to treat patients. "
The objective of the trial is to compare mortality among patients receiving one of the three investigational drugs against Ebola with a control group of patients receiving cocktail treatment with monoclonal antibodies in ZMapp research, developed by Mapp Biopharmaceutical, Inc. The therapies being tested include: mAb114, a single monoclonal antibody developed by NIAID, with early support of the INRB; and remdesivir (also known as GS-5734), an antiviral drug developed by Gilead Sciences, Inc. The trial has been approved to begin enrolling patients in these three groups, and there are plans in the pipeline to amend the trial to include REGN-EB3 (also known as REGN3470-3471-3479), a cocktail of monoclonal antibodies developed by Regeneron Pharmaceuticals, Inc.
The participating Ebola treatment units will continue to provide all participants with supportive care for the EVE. Ebola care includes oral and / or intravenous support fluids, electrolyte replacement, maintenance of oxygen status and blood pressure, and pain management.
Research treatments have different levels of data to support their use of tests in the laboratory, animals and humans. However, none has been approved to treat EVD. ZMapp is the only research treatment previously tested in a randomized controlled efficacy trial. The results of that study, conducted in the US UU And West Africa during the 2014-2016 outbreak, suggested that ZMapp appeared to be beneficial, but as the outbreak declined, the trial eventually failed to include enough participants to definitively establish the efficacy of the medication.
Research treatments have also been administered to the majority of Ebola patients in the current outbreak in the Democratic Republic of the Congo under an ethical framework developed by the WHO called Monitored Emergency Use of Unregistered and Investigative Interventions (MEURI). However, this emergency use mechanism can not provide generalizable evidence on how well treatments work.
"It is necessary to conduct a randomized controlled trial to obtain reliable data on the safety and efficacy of treatments in research against Ebola," said H. Clifford Lane, MD, director of the NIAID Clinical Research Division. "It is possible to conduct a rigorous clinical investigation in an outbreak environment, and we anticipate that this trial will provide useful data."
Professor Jean-Jacques Muyembe-Tamfum, MD, Ph.D., general director of INRB, and Richard T. Davey, Jr., MD, deputy director of the NIAID Clinical Research Division, are co-principal investigators for the study .
Trial participants will be randomly assigned to receive one of the investigational treatments by intravenous infusion. Clinic doctors will monitor patients' symptoms and take blood samples for laboratory tests. Patients will remain in the Ebola treatment unit until they fully recover from the disease. They will be asked to return to the clinic approximately two months after receiving treatment for a check-up and to provide additional blood samples for laboratory tests.
Plans are underway to extend the trial beyond the ALIMA site in Beni to additional Ebola treatment units operated by humanitarian medical organizations, including the International Medical Corps. The trial can also be adapted to continue in more than one outbreak and in several countries. The number of participants enrolled in the trial will ultimately depend on the evolution of Ebola outbreaks. The study is designed to enroll 112 patients per arm, potentially in multiple outbreaks.
"This clinical trial marks an important and important step forward for the DRC and our international partners," said Dr. Muyembe. "We are eager to learn more about each of these research treatments as we continue to work tirelessly to identify new cases, track contacts and control the spread of the disease."
An independent data monitoring and security board will regularly review the study data. For more information, visit ClinicalTrials.gov and look for the identifier NCT03719586.
The NIAID conducts and supports research, at the NIH, throughout the United States and around the world, to study the causes of infectious diseases and mediated by the immune system, and to develop better means to prevent, diagnose and treat these diseases . Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.
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