The Democratic Republic of Congo has kicked off the world’s first multidrug randomized control trial to evaluate the effectiveness and safety of experimental drugs used to treat Ebola patients, the World Health Organization announced Monday.
“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,” WHO Director-General Dr. Tedros Adhanom Ghebreyesus said in a statement Monday.
“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,” he said. “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.”
In August, Congo’s Ministry of Health reported an outbreak of Ebola virus disease in North Kivu province. The outbreak emerged about a week after the government declared that a previous outbreak had ended.
The new outbreak – the second this year – began in North Kivu and spread to Ituri province in the east of the country. The two provinces, which are among the most populated in the nation, border Uganda, Rwanda and South Sudan.
The outbreak marks the 10th time since 1976 that Ebola has struck Congo.
An accumulation of evidence
More than 160 patients have been treated with investigational therapeutics under a protocol called the Monitored Emergency Use of Unregistered and Investigational Interventions, which was designed not to test the drugs but rather to provide them as something similar to a compassionate use, for instance.
With the new trial, patients can be offered treatments under that framework of the study, according to WHO.
The trial is coordinated by WHO and led and sponsored by Congo’s National Institute for Biomedical Research, in partnership with the Ministry of Health, the US National Institute of Allergy and Infectious Diseases and the Alliance for International Medical Action, among other groups.
Last month, 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 possible Ebola outbreak.
Over time, the trials could lead to an accumulation of evidence and research that will help better the world’s understanding of the effectiveness of currently available Ebola drugs and new drugs that may be developed.
‘The security situation is a significant impediment’
Congo is experiencing not only an Ebola outbreak but a long-term humanitarian crisis that includes intermittent armed conflict and violence, which has hampered efforts to stamp out the deadly outbreak in the northeast.
The minister of public health, Oly Ilunga Kalenga, said this month that violence against health officials and civilians by militant groups battling for control in the affected region has thwarted efforts to contain the outbreak.
“No other epidemic in the world has been as complex as the one we are currently experiencing,” Kalenga said in a video statement posted on Twitter.
In October, two health workers died in one attack, he said, and 11 civilians were killed in Beni, a city of 800,000 people and the epicenter of the outbreak.
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The United States has decided that it is no longer safe to have government personnel on the ground in Beni, said Tim Morrison, special assistant to the president and senior director for weapons of mass destruction and biodefense at the National Security Council.
Personnel have been pulled back from the worst affected areas due to those safety concerns.
“The security situation remains tenuous and it is the position of the US government, there is no disagreement, that the security of our staff, the safety of our staff, the security of our personnel is our highest priority,” Morrison said.
“We are looking at every option available to us to provide assistance, technical expertise to the region, but the security situation is a significant impediment,” he said. “This is a specific challenge from a security perspective but it is not in any way impeding our ability to provide financial and technical assistance.”