Clinical trial for Ebola therapies begins in DR Congo

As cases and deaths in the Ebola outbreak in the Democratic Republic of the Congo (DRC) continue to climb, the World Health Organization (WHO) said today that the first patient been treated in a clinical trial for two antiviral therapies.

The randomized platform trial will evaluate whether the monoclonal antibody MBP134 and the antiviral drug remdesivir, alone or in combination, can improve survival in patients of any age with confirmed Bundibugyo virus disease. Bundibugyo virus, the strain responsible for the outbreak, has no licensed therapeutics or vaccines. 

The trial, which is being run by DRC’s National Institute for Biomedical Research, Oxford University, and the Institute of Tropical Medicine in Belgium, will have four treatment groups: one will receive MB134, one will receive remdesivir, a third will receive both therapies, and a control group will receive the best-quality care. Additional treatments will be added as they become available.

MBP134 is pan-Ebolavirus monoclonal antibody developed by Mapp Biopharmaceuticals. Remdesivir, developed by Gilead Sciences, is an antiviral most well-known as a treatment for hospitalized COVID-19 patients. Both were recommended for prioritization by the WHO Technical Advisory Group. Neither have been tested in people for the treatment of Ebola.

Vasee Moorthy, MD, PhD, acting lead of the WHO’s R&D Blueprint group, said at a press briefing this morning that the trial could take some time.

“We shouldn’t expect that this is going to be over in weeks, it will take some months, it could go even into next year, it could be that we need a thousand patients enrolled in the trial until we get a definitive answer,” Moorthy said. “That could be earlier if there is a very high efficacy from the trial.”

WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said that the organization is working to ensure that patients in DRC will have access to the two drugs “should they prove safe and efficacious in the trial.” He also said the WHO has given emergency use listing to the first molecular diagnostic test for Bundibugyo virus.

Community mistrust continues to impede response

Tedros said 1,406 cases have been confirmed in the DRC, and 438 people have died. Neighboring Uganda has recorded an additional 20 cases and two deaths. While highlighting improvements in testing, contact tracing, and treatment capacity in DRC, Tedros cautioned that the response continues to face significant challenges, including mistrust and violence.

“Just this week, an Ebola treatment center in Ituri province was attacked, resulting in the deaths of two people. The center was set on fire, and patients fled,” he said. “Such acts not only endanger patients and health workers but also impede efforts to stop transmission and save lives.”

Such acts not only endanger patients and health workers but also impede efforts to stop transmission and save lives.

Chikwe Ihekweazu, MPH, executive director of the WHO Health Emergencies Programme, said the violence was in response to the local population’s aversion to local officials taking charge of burials of Ebola victims. Because the virus remains highly infectious after an Ebola patient has died, burials need to be conducted by trained health workers in personal protective equipment.

“Every time there’s an incident like this, it sets the whole response back,” Ihekweazu said. He said WHO officials were meeting with community members to explain that the protocols are necessary to keep the virus from spreading.

Ihekweazu added that community mistrust is just one of the factors making it difficult to get the outbreak under control in the three provinces—Ituri, North Kivu, and South Kivu—at the epicenter of the outbreak. All three have been plagued by food insecurity and conflict between the Congolese military and militia groups, which has caused massive internal displacement.

“The outbreak is happening in this context, and, unfortunately, the conflation between a very difficult humanitarian context and a very difficult infectious disease context is coming together to cause challenges in responding to this outbreak,” he said.