A health worker takes a woman’s temperature as part of Ebola screening efforts in Goma, Democratic Republic of the Congo. As part of the effort to quell the outbreak, the first patients have been enrolled in a clinical trial to test two drugs against the Bundibugyo strain of the virus that is spreading there. Additionally,
A health worker takes a woman’s temperature as part of Ebola screening efforts in Goma, Democratic Republic of the Congo. As part of the effort to quell the outbreak, the first patients have been enrolled in a clinical trial to test two drugs against the Bundibugyo strain of the virus that is spreading there. Additionally, researchers plan to study whether another drug could protect people exposed to the virus.
Daniel Buuma/Getty Images
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Daniel Buuma/Getty Images
It has been more than 50 days since the Ebola outbreak was declared in the Democratic Republic of the Congo and Uganda. Doctors on the ground are working to save dying patients, but they lack crucial tools to combat the type of Ebola that is spreading.
“We urgently need treatments that can help people affected by Bundibugyo virus disease,” he says. Amanda Rojeka physician-scientist at the University of Oxford, this is a rarer species of Ebola than the much-researched Zaire strain behind many previous outbreaks.
But because of that rarity, there are no specialized treatments for patients. There are also no medications that can protect people exposed to the virus from getting sick.
That reality is changing. Clinical trials are underway or will soon be conducted to test new tools that health officials hope can help turn the tide of an outbreak that has already killed more than 500 people and sickened more than 1,560, and which some say could become the largest Ebola outbreak in history.
Last Thursday, the World Health Organization announced that the first patients were enrolled in a clinical trial designed to test two drugs against Bundibugyo. And sometime this week, researchers will likely begin studying whether another drug could protect people exposed to the virus.
“One of the key lessons from recent outbreaks is that research needs to be done alongside the response, not after,” says Rojek, who is helping to coordinate treatment trials.
The three trials are a collaborative effort between WHO, Africa CDC, universities and nonprofit organizations. Each will test existing medications against Bundibugyo.
“Starting from scratch takes years,” he says. Salim Abdool Karimdirector of the Center for AIDS Research Program in South Africa and a member of the Africa CDC emergency committee that has been following the outbreak. “So we take the existing medications and see if [they] “can be reused.”
“This will take some time”
For the treatment of Ebola, researchers are testing two drugs, the antiviral remdesivir, made by Gilead Sciences, and the monoclonal antibody MBP-134, developed by Mapp Biopharmaceutical. Both medications are administered intravenously.
Remdesivir rose to prominence during the COVID-19 pandemic, when it was used (with mixed effect) to treat patients in the hospital. But the drug was developed to attack a wide range of viruses, including Ebola. It was tested during the 2018 Ebola outbreak in the Democratic Republic of the Congo, but was relatively ineffective against the Zaire species.
MBP-134 is a monoclonal antibody treatment, designed to mimic the immune system’s natural defenses against the virus. It is a cocktail of two monoclonal antibodies, both isolated from a survivor of the 2014-2016 West African Ebola outbreak, also caused by the Zaire species. but there are some laboratory data that suggests it could work against Bundibugyo.
The Biomedical Advanced Research and Development Authority, or BARDA, played a major role in funding the research behind MBP-134 and technically owns the doses. BARDA is a US government agency within the Department of Health and Human Services and the government has donated the doses needed for the clinical trial, according to Vasee Moorthy, WHO’s research and development lead for the outbreak.
Each medication will be tested alone and in combination with the current standard of care. supportive therapy which aims to replace lost fluids and control pain. So far, only one clinic in the Democratic Republic of the Congo is participating in the trial, but there are plans to expand it in the coming weeks, Moorthy said at a news conference last Thursday.
Researchers will monitor whether the drugs increase survival. How long it takes depends on a variety of factors, Moorthy says.
“From what we see right now, this will take some time,” he said. “It will take a few months. It could even last until next year. It could be that we need to enroll more than 1,000 patients in the trial until we get a definitive answer.” If either treatment proves super effective, that timeline could be shorter, he said.
Treatments are not enough
To help control the epidemic, which shows no signs of slowing down anytime soon, health officials need more than treatments. They need to prevent people from getting sick, he says Yazdan Yazdanpanahinfectious diseases physician and epidemiologist at ANRS Emerging Infectious Diseases, a French research agency.
The best thing would be a vaccine, “but today we don’t have a vaccine,” he says, and it will be months before candidate testing begins. But giving an antiviral soon after exposure can help prevent disease and could work faster than a typical vaccine.
That’s where the third trial, scheduled to begin this week, comes in, Yazdanpanah says. He and his colleagues will test whether taking obeldesivir pills, an antiviral also made by Gilead Sciences, can help prevent close contacts of Ebola cases from contracting the disease, a method known as post-exposure prophylaxis.
The study relies heavily on contact tracers who quickly identify anyone who may have been exposed to an Ebola patient. For contacts who enroll, the research team will come to the participant twice a day to deliver medication and follow up if they develop symptoms.
If obeldesivir proves effective, it could become a powerful tool to stop the epidemic, says Yazdanpanah. It could also help attract more contacts to come forward, since health officials would have something to give them besides instructions to quarantine.
Challenges ahead
Demonstrating the effectiveness of any of these three drugs will depend on clinical trials being carried out without problems. That’s a challenge in any outbreak, especially one beset by ongoing armed conflict.
There has also been violence directed at health centers. Several have been attacked since the outbreak, likely sparked by mistrust. Community members are often wary of outside healthcare workers who arrive in their city in full protective gear. There are rumors that humanitarian aid groups are murder people or retain attention.
In fact, WHO officials refused to reveal the exact location of the clinic now enrolling patients for treatment trials to protect its doctors.
“There is a lack of trust,” says Yazdanpanah. Building that trust in the community is crucial to conducting an effective and ethical clinical trial. WHO officials hope that will be the result of holding many community advisory meetings, involving everyone from health care workers to religious groups.
“Conversations with the community are absolutely critical,” Moorthy said. “There are open lines of communication with the testing team from the community, so we can ensure their interests come first.”
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