In response to the August 2018 outbreak of the Ebola Zaire Virus in the Democratic Republic of the Congo (DRC), the Congolese Ministry of Health (MoH) announced on 26 November 2018, the first-ever multi-drug Ebola trial. It will form part of a multi-outbreak, multi-country study that was agreed to by partners under a World Health Organization (WHO) initiative. It will take the form of a randomised controlled trial (RCT), which involves two groups chosen at random, an experimental group to receive the trial drug, and a control group.
According to UNICEF, the strength of RCTs is that they provide “a very powerful response to questions of causality, helping evaluators and programme implementers to know that what is being achieved is as a result of the intervention and not anything else.”
World Health Organization (WHO) Director-General Dr. Tedros Adhanom Ghebreyesus, regards this trial as a “giant step” for DRC, which will “bring clarity about what works best, and save many lives in the years to come.”
The drug trial will form part of a multi-outbreak, multi-country study, agreed to by partners under a WHO initiative. Under the RCT, data gathered will become standardised and will be used to draw conclusions about the safety and efficacy of the drugs in relation to treatment of the Ebola virus.
Until now, Ebola treatment drugs have been administered under MEURI protocol, which does not evaluate their effectiveness. Drugs administered under MEURI protocols for compassionate use during outbreaks are done so as a mechanism for enhancing patient survival chances. This means that although a full regulatory process has not yet formally approved the drug, it has been proven sufficiently safe and effective to be recommended for use, with no recognised viable alternative treatment. This RCT aims to determine how successful these drugs are in combating Ebola, which will greatly strengthen management and prevention of Ebola outbreaks in the future.
Unlike previous trials, this RCT will be conducted among a coalition of organisations, rather than individually. It will be coordinated by WHO, and led and sponsored by the DRC’s National Institute for Biomedical Research (INRB), in partnership with the DRC MoH, the National Institute of Allergy and Infectious Diseases (NIAID), The Alliance for International Medical Action (ALIMA), and other humanitarian and medical organizations.
“This clinical trial is unique in its kind: to avoid a repeat of the disjointed clinical research that took place during the major West Africa epidemic of 2014-2016, this time all stakeholders are gathered in a single consortium,” said ALIMA’s President, Dr. Richard Kojan. “This will allow faster, more reliable results and therefore provide better care to people affected by Ebola.”
WHO reiterates that respect and fairness to communities and patients affected by Ebola remains at the heart of the long-term outbreak management plan and the upcoming RCT. While the trial will help to further understanding and allow for future control mechanisms, the focus of DRC officials and humanitarian aid in the region remains on controlling the outbreak and preventing further loss of life through prevention methods and community engagement.