The Ministry of Health of the Democratic Republic of the Congo (DRC) announced on Monday that a randomized control trial has begun to evaluate the effectiveness and safety of drugs used in the treatment of Ebola patients. The trial is the first-ever multi drug trial for an Ebola treatment. It will form part of a multi-outbreak, multi-country study that was agreed to by partners under a World Health Organization (WHO) initiative.
“While our focus remains on bringing this outbreak to an end, the launch of the randomized control trial in DRC is an important step towards finally finding an Ebola treatment that will save lives,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “Until now, patients have been treated under a compassionate use protocol, with drugs that showed promise and had a good safety profile in laboratory conditions. The giant step DRC is taking now will bring clarity about what works best, and save many lives in years to come. We hope to one day say that the death and suffering from Ebola is behind us.”
Until now, over 160 patients have been treated with investigational therapeutics under an ethical framework developed by WHO, in consultation with experts in the field and the DRC, called the Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). The MEURI protocol was not designed to evaluate the drugs.
Now that protocols for trials are in place, patients will be offered treatments under that framework in the facilities where the trial has started. In others, compassionate use will continue up to the time when they join the randomization. Patients will not be treated noticeably differently from before, though the treatment they receive will be decided by random allocation. The data gathered will become standardized and will be useful for drawing conclusions about the safety and efficacy of the drugs.
“Our country is struck with Ebola outbreaks too often, which also means we have unique expertise in combating it,” said Dr Olly Ilunga, Minister of Health of the DRC. “These trials will contribute to building that knowledge, while we continue to respond on every front to bring the current outbreak to an end.”
In October, WHO convened a meeting of international organizations, United Nations partners, countries at risk of Ebola, drug manufacturers and others to agree on a framework to continue trials in the next Ebola outbreak, whenever and wherever that is. Over time, this will lead to an accumulation of evidence that will help to draw robust conclusions across outbreaks about the currently available drugs, and any new ones that may come along.
At the heart of the long term plan and the current trial is always the goal to ensure that patients with Ebola and their communities are treated with respect and fairness. All patients should be provided with the highest level of care and have access to the most promising medications.
The current trial is coordinated by WHO, and led and sponsored by the DRC’s National Institute for Biomedical Research (INRB), in partnership with the DRC Ministry of Health, the National Institute of Allergy and Infectious Diseases (NIAID) which is part of the United States’ National Institutes of Health, The Alliance for International Medical Action (ALIMA) and other organizations.