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The Ministry of Health of the Democratic Republic of Congo (DRC) today announced the holding of a randomized controlled trial to evaluate the efficacy and safety of drugs used in the treatment of patients affected by the Ebola virus. This is the first ever multi-drug trial for Ebola treatment. It will be part of a multi-epidemic and multi-country study accepted by partners as part of an initiative of the World Health Organization (WHO).
"While our goal remains to end this epidemic, the launch of the randomized controlled trial in the DRC is an important step towards the definitive discovery of an Ebola treatment that will save lives," said the Dr. Tedros Adhanom Ghebreyesus, Director General of WHO. "Until now, patients were treated according to a protocol of compassionate use, with promising drugs and having a good safety profile in the laboratory. The giant step that the DRC is taking now will clarify what works best and save many lives in the years to come. We hope someday to say that the death and suffering caused by Ebola are behind us. "
So far, more than 160 patients have been treated with experimental therapeutics in an ethical setting developed by WHO, in consultation with experts in the field and in the DRC, called Emergency Surveillance Use of experimental unregistered and experimental interventions (MEURI). The MEURI protocol was not designed to evaluate drugs. Now that testing protocols are in place, patients will be offered treatment in this setting in the facilities where the trial began. In other cases, the compassionate use will continue until the moment they join the randomization. Patients will not be treated differently from before, although the treatment they will receive is decided by random assignment. The collected data will become standardized and will be useful for drawing conclusions about the safety and effectiveness of drugs.
"Our country is too often struck by Ebola outbreaks, which also means we have unique expertise to fight it," said Dr Olly Ilunga, DRC's Minister of Health. "These trials will contribute to the acquisition of this knowledge, while continuing to intervene on all fronts to put an end to the current epidemic."
In October, WHO convened a meeting of international organizations, UN partners, countries at risk of Ebola, drug manufacturers and other actors to agree a framework for further testing in the next Ebola outbreak, where and when. Over time, this will lead to an accumulation of evidence that will help draw solid conclusions from one epidemic to another about currently available medications and about any new drug that may come up.
The central goal of the long-term plan and ongoing trials is always to ensure that patients with Ebola and their communities are treated with respect and fairness. All patients should receive the highest quality of care and have access to the most promising drugs.
The ongoing trial is coordinated by WHO and led and sponsored by the National Institute of Biomedical Research of the DRC (INRB), in partnership with the DRC Ministry of Health, the Ministry of Health. 39; National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health States, the Alliance for International Medical Action (ALIMA) and 39; other organizations.
The deliberations of the consultation are available here.
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