The Democratic of Republic of Congo is using an unfolding Ebola outbreak within its borders to conduct a groundbreaking trial of multiple drugs that could combat the deadly disease, the public arm of the U.N. said Monday.
The effort, announced Monday, will involve four drugs that had been used with some success under a so-called “compassionate use” framework, the World Health Organization said.
The randomized trial, however, will allow scientists to methodically compare the relative effectiveness therapies for the first time.
“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,” WHO Director-General Dr. Tedros Ghebreyesus said.
Patients will not be treated much differently than they were under the compassionate-use protocol, though drugs will now be randomly allocated.
Scientists will standardize the data and draw conclusions about safety and efficacy. The trial will start in Beni — a town at the center of the outbreak — with drugs known as Mab 114, Remdesivir and ZMapp, though a fourth, Regeneron, will be used once additional sites are up and running.
WHO officials said the trial will need a “few hundred” patients to be scientifically valid, though it’s unclear if they will amass that many.
“Because the aim is to end the current outbreak as quickly as possible, there may not be sufficient data from this one trial to draw conclusions,” WHO spokesman Tarik Jasarevic said. “Further trials in further outbreaks will eventually gather enough data to make conclusions about the efficacy of the drugs. The goal in every outbreak is always to end it as soon as possible.”
Ebola is a serious, often-fatal disease that is transmitted to people from wild animals and spreads from human to human through the bodily fluids of people who exhibit symptoms.
The DRC health ministry has documented more than 400 confirmed or suspected cases in the current outbreak in North Kivu province, making it the worst the DRC has seen.
It’s the third worst in global history, trailing the massive West African outbreak that killed more than 11,000 earlier this decade and an outbreak that struck Uganda nearly two decades ago, resulting in over 400 cases. But the weakness of the DRC’s central government and the difficulty of reaching some affected areas has health professionals especially nervous.
The response to the unfolding outbreak, which has been blamed for 236 deaths, has been hampered by violent attacks from rebel groups that operate in the region.
WHO says it does not view the outbreak as a global emergency just yet, though it’s worried the virus will jump the border into Uganda. More than 1,100 Ugandan health workers have received a trial vaccine for Ebola as a precaution.
“This is historic: the first-ever administration of the [Ebola] vaccine in a country BEFORE the disease arrives there,” Ronald Klain, who served as President Obama’s “Ebola czar” during the West African outbreak, tweeted on Monday.
The trial vaccine, known as rVSV-ZEBOV, appeared to be effective during a Guinea trial amid the West African outbreak earlier this decade. The vaccine also has been deployed in the DRC.
Merck, the pharmaceutical company that supplies it, announced last week it has begun submitting documents to the Food and Drug Administration to seek a license for the vaccine. It expects the rolling submission of data to be completed in 2019.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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