The Ministry of Health in the Democratic Republic of Congo (DRC) today announced that a randomized control study has begun…
The Ministry of Health in the Democratic Republic of Congo (DRC) today announced that a randomized control study has begun evaluating the efficacy 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 be part of a multi-outbreak, a multinational study agreed by partners in the framework of a World Health Organization (WHO) initiative.
“While focusing on getting this outbreak to an end, the launch of the Randomized Control Process in the DRC should be an important step towards finally finding an Ebola treatment that will save lives,” said WHO Director General Dr Tedros Adhanom Ghebreyesus. “So far, patients have been treated with a uncompromising use protocol, with drugs that showed promise and had a good safety profile at laboratory conditions. The huge step DRC takes now will clarify what works best and save many years this year. We hope that we Today says the death and suffering of Ebola lies behind us. “
So far, over 1
60 patients have been treated with investigative therapeutic agents according to an ethical framework developed by the WHO, in consultation with experts in the field and the Democratic Republic of Congo, called the supervised emergency use of unregistered and investigative 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 establishments where the trial has begun. In others, compassion will continue until the time they participate in the randomization. Patients are not treated significantly differently than before, but the treatment they receive is determined by random distribution. The data collected will be standardized and will be useful for drawing conclusions about the safety and efficacy of the drug.
“Our country is suffering from ebola eruptions too often, which means we have unique skills to fight it,” said Dr Olly Ilunga, Minister of Health in the Democratic Republic of the Congo. “These attempts will help build that knowledge, while we continue to respond to each front to end the current outburst.”
In October, the WHO convened a meeting of international organizations, UN partners, countries at risk of Ebola, drug manufacturers and others to agree on a framework for continuing trials in the next Ebola eruption, whenever and wherever. Over time, this will lead to an accumulation of evidence that will help to draw strong conclusions about outbreaks of current available drugs and any new ones that may come with.
The essence of the long-term plan and the current attempt is always the goal of ensuring that patients with Ebola and their communities are treated with respect and justice. All patients should get the highest level and have access to the most promising medicines.
The ongoing trial is coordinated by the WHO and led and sponsored by the DRC National Institute for Biomedical Research (INRB) in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) of the United States National Institute of Health, Alliance for International Medical Action (ALIMA) and other organizations.
(With entries from the South African Government Press Release)