A team of doctors and other researchers from Duke and UNC-Chapel Hill is providing much of the technical expertise for a new clinical study in West Africa treating Ebola patients with transfusions of blood plasma from survivors of the deadly virus.
The study, believed to be the first of its kind, enrolled its first patient three weeks ago and is being conducted at ELWA hospital operated by the Charlotte charity group SIM in Monrovia, the Liberian capital.
The main goal is to determine whether the approach is safe and effective in reducing the chances of dying from the disease.
The treatment is the brainchild of an Ohio company called Clinical Research Management that received a $5.7 million grant from the Bill & Melinda Gates Foundation for the project, then recruited several Duke and UNC doctors with pertinent expertise, who in turn tapped others here.
“That’s the beauty of working with two universities that have deep benches,” said Dr. David Wohl, an associate professor at the UNC School of Medicine. “Because as we need things like statistical help, as we need people who might be able to help us with community outreach, as we need people who have hands-on experience with actual clinical trial data collection, we have been able to tap into that.”
Wohl and UNC-Chapel Hill critical-care doctor William Fischer II traveled to Monrovia for two weeks in December to start the study, then came home for a break.
Duke physician Coleen Cunningham is in Monrovia now, working on the study, and Wohl and Fischer plan to return in about a week.
Fischer is an infectious-disease expert who did a stint last year treating patients in an Ebola clinic. Wohl has done substantial clinical research with HIV, which has several parallels with Ebola.
A team effort
Cunningham, an expert in pediatric infectious disease, has done international work with HIV.
Chris Woods, co-director of Duke’s Hubert-Yeargan Center for Global Health, also is part of the project. He’s now in Alabama getting hands-on training for working with Ebola patients.
“It all really becomes a team effort,” Woods said, “and there are many people not directly involved who are willing to take on additional work, to allow us to do this in an emergency mode.”
There isn’t a clinically proven treatment for Ebola, but the horror of the epidemic, which has killed more than 8,000 people according to the United Nations, has prompted several searches for one and led to an influx of Western health care workers helping counterparts in West Africa.
“I think this is one of those rare moments when people put their competitive interests aside and really start focusing on what’s important,” Fischer said, “and that’s improving the delivery of care, and figuring out which interventions are going to save lives, and which interventions are wasting time.
“There’s an incredible sense of urgency, but there is also an incredible sense of camaraderie,” Fischer said.
So far the study has enrolled four patients. The goal is to get about 70, but growth has been slow because Liberia – unlike the other two countries hit hard by the epidemic, neighboring Guinea and Sierra Leone – has managed to slow the pace of new infections.
The study was designed to give plasma to subjects as it became available, while comparing their outcomes to those of other patients.
Researchers decided to improve care for all Ebola patients in the Monrovia facility, not just those getting plasma.
That didn’t mean radical changes, Fischer said, since they already were receiving high-quality care, including intravenous hydration, regarded as crucial for reducing death rates from Ebola. In fact, Jerry Brown, the Liberian doctor who runs the hospital’s Ebola efforts and is the lead investigator for the study, was featured on the cover of Time magazine last month for its Person of the Year issue, in which it honored the health care workers battling the epidemic.
“The dedication and loyalty among the Liberian staff – Jerry Brown, the physician assistants, the nurses – it’s absolutely unparalleled,” Fischer said. “I’ve talked about how hard it is to be in those protective suits for three weeks to six weeks of shifts, but these guys have been doing it since the epidemic began, and they don’t take days off.”
Ebola survivors organize
The main thing researchers did to help the staff at the hospital was bring sophisticated hand-held equipment to analyze patients’ blood in real time. That helps them fine-tune the hydration fluid to make it more effective.
Plasma is the liquid component of blood that carries the red and white cells. Antibodies in the blood of cured Ebola victims are believed to help those suffering from the disease.
While whole blood could be used for the study, donors can give more plasma and give it more often. Also, plasma is less likely to cause a bad reaction in a recipient.
The plasma is tested to make sure it has the desired antibodies and doesn’t include pathogens such as HIV, said Dr. David Hoover, the Ebola program director for Clinical Research Management. The plasma also is run through machines that render pathogens inert.
Death rates from Ebola can be as high as 90 percent but are lower where patients get better care. That means there are thousands of people in Africa available to donate useful plasma.
In Liberia, at least, many are eager to do that, Wohl said. As those infected with HIV did in the U.S., many Ebola survivors have begun mobilizing and creating organizations to advocate for themselves.
“We met with the leader of one of them, a major one with 200 members, and they’re advocating for services, for recognition, for an end to stigmatization,” Wohl said. “They’re organizing, holding workshops, creating mission statements, and so tapping into that was very useful for us, because they want to see change, and they want to be part of that change.”
Some survivors, Fischer said, see donating plasma as a way to strike back at the disease that has ravaged their families and communities.
The researchers plan to expand the project to investigate other means of fighting Ebola, including the evaluation of new drugs and drugs currently used for other diseases, among other methods.
“This is a platform, and the plasma study is the first in a series that we hope to bring to the field to look at what can be done,” Wohl said. “Plasma is not probably going to be the magical bullet, so we really need to think beyond that. Can we do things in addition to plasma, or do things along with plasma, and are there other ways to treat the epidemic?
“We can not only be treating the disease but thinking about ways to prevent people from getting it in the first place,” Wohl said.