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Clinical Trial of Experimental Ebola Treatments Begins in Democratic Republic of Congo



Press release

Tuesday, November 27, 2018

An international research team has begun recruiting patients for a clinical trial testing several experimental Ebola therapies in the Democratic Republic of Congo (DRC). Randomized Controlled Trial Recruits Patients of All Ages with Confirmed Ebola Virus Disease in a Treatment Facility in Beni City Run by ALIMA (The Alliance for International Medical Action), a Humanitarian Organization medical vocation.

The trial, which will extend to other districts of the DRC, is organized through an international research consortium coordinated by the World Health Organization (WHO). ). It is directed and funded by the National Institute of Biomedical Research (INRB), which is part of the DRC Ministry of Health, and by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health of the United States. additional international partners.

"The fight against Ebola requires a comprehensive response that builds on the strengths of all areas of public health. Biomedical research can lead to new vital tools, such as lifesaving therapies, "said Anthony S. Fauci, Director of NIAID." Through scientifically and ethically sound clinical trials, we hope to effectively establish and definitive safety and effectiveness of these drugs. Experimental treatments against the Ebola virus, offering new ways to save lives. "

On August 1, 2018, the DRC Ministry of Health declared the tenth home of the country. As of November 25, 2018, 240 deaths out of 419 confirmed and probable cases of EVD have been reported in North-East Kivu and Ituri Provinces. Under the leadership of the DRC Ministry of Health, WHO has coordinated the fight against the epidemic with several international partners. NIAID, together with the US Centers for Disease Control and Prevention, the United States Agency for International Development (USAID) and other US government partners, provided guidance and support to the multisectoral response to epidemics .

"We urgently need safe and effective treatment for this deadly disease," said DRC Health Minister Oly Ilunga Kalenga, MD, Ph.D. "While we face a 10th Ebola outbreak, we hope that this clinical trial will give us more information on the best way to treat patients. "

The purpose of the trial is to compare mortality in patients receiving any of the three experimental Ebola drugs with a control group of patients receiving the experimental treatment ZMapp, a monoclonal antibody cocktail developed by Mapp Biopharmaceutical, Inc. The treatments tested include: mAb114, a unique monoclonal. antibodies developed by NIAID, with early support from INRB; and Remdesivir (also known as GS-5734), an antiviral drug developed by Gilead Sciences, Inc. The trial was approved to begin recruiting patients in these three groups, and projects are underway. course of amendment to include REGN-EB3 (also known as REGN3470-3471-3479), a monoclonal antibody cocktail developed by Regeneron Pharmaceuticals, Inc.

Participating Ebola treatment units will continue to provide Ebola support to all participants. Ebola care includes oral and / or intravenous fluids, electrolyte replacement, maintenance of oxygen status and blood pressure, as well as treatment of the patient. pain.

Experimental treatments have varying levels of data to support their use in laboratory, animal, and human trials. However, none has been approved for the treatment of EVD. ZMapp is the only experimental treatment previously tested as part of a randomized, controlled efficacy study. The results of this study, conducted in the United States and West Africa during the 2014-2016 epidemic, suggest that ZMapp appears to be beneficial, but as the epidemic falters, test no. has finally failed to recruit enough participants to definitively establish the effectiveness of the drug.

Experimental treatments have also been administered to most Ebola patients during the current outbreak in the DRC as part of an ethical framework developed by the WHO and called Surveillance Use. Urgency of unregistered and experimental experimental interventions (MEURI). However, this mechanism of emergency use can not provide any generalizable evidence about the effectiveness of treatments.

"A randomized, controlled clinical trial is needed to obtain reliable data on the safety and efficacy of experimental Ebola treatments," said H. Clifford Lane, MD, director of NIAID's Clinical Research Division. . "It is possible to conduct rigorous clinical research in an epidemic situation, and we anticipate that this trial will provide useful data."

Professor Jean-Jacques Muyembe-Tamfum, MD, Ph.D., Director General of INRB, and Richard T. Davey, Jr., MD, Deputy Director of the Clinical Research Division of NIAID, are the co-principal investigators of the study. .

Trial participants will be randomly assigned to one of the experimental intravenous infusion treatments. Site clinicians monitor patients' symptoms and take blood samples for laboratory tests. Patients will remain in the Ebola treatment unit until they are completely cured of the disease. They will be asked to return to the clinic about two months after treatment for a checkup and to provide additional blood samples for laboratory tests.

Plans are underway to expand testing beyond the ALIMA site in Beni to other Ebola treatment units run by medical humanitarian organizations, including International Medical Corps. The test can also be adapted to continue on several epidemics 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 include 112 patients per arm, potentially on multiple epidemics.

"This clinical trial represents a significant and important step forward for the DRC and our international partners," said Dr. Muyembe. "We are eager to learn more about each of these experimental treatments, as we continue to work tirelessly to identify new cases, search for contacts, and control the spread of the disease."

An independent data and safety monitoring committee will regularly review the study data. For more information, visit ClinicalTrials.gov and look for the NCT03719586 identifier.

NIAID conducts and supports research – at NIH, across the United States and around the world – to investigate the causes of infectious and immune-mediated diseases and to develop better ways to prevent, diagnose and treat these diseases. . News releases, fact sheets and other documents related to NIAID are available on the NIAID website.

About the National Institutes of Health (NIH):
The NIH, the country's medical research agency, comprises 27 institutes and centers, and is part of the US Department of Health and Human Services. NIH is the lead federal agency that leads and supports basic, clinical and translational medical research. She studies causes, treatments and treatments for common and rare diseases. For more information on NIH and its programs, visit www.nih.gov.

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