A clinical trial to evaluate the experimental Ebola treatment ZMapp found it to be safe and well-tolerated; however, because of the waning Ebola epidemic, the study enrolled too few people to determine definitively whether it is a better treatment for Ebola virus disease (EVD) than the best available standard of care alone.
About the study
The study sought to determine if the experimental drug ZMapp plus the optimized standard of care for treating EVD — providing intravenous fluids, balancing electrolytes needed to maintain bodily functions, and maintaining healthy oxygen and blood pressure levels — was superior to the optimized standard of care alone in reducing deaths. All participants received the optimized standard of care, and half were randomly assigned to also receive three intravenous infusions of ZMapp.
Investigators compared the number of deaths at 28 days after enrollment. Thirteen deaths (37 percent) were reported in the group of 35 patients who received the optimized standard of care only, while eight deaths (22 percent) occurred in the ZMapp group of 36 patients. One patient left treatment early and was not included in the analysis.
Although the difference between the two groups translates to a 40 percent lower risk of death for those who received ZMapp, the difference did not reach statistical significance.
The findings appeared in the Oct. 13, 2016 issue of The New England Journal of Medicine.
UNMC was one of several sites involved in the study. Chris Kratochvil, M.D., UNMC associate vice chancellor for clinical research, and Andre Kalil, M.D., were research investigators and members of the National Institutes of Health team that designed the multinational study.
“This trial was designed and developed during the height of the EVD epidemic, which was well underway by the time the study was initiated,” Dr. Kratochvil said. “We are already planning future trials with NIH and our other collaborators, so when the next outbreak occurs we will be much better prepared.”
Dr. Kalil, professor of medicine in the UNMC Division of Infectious Diseases, said the study was a fantastic effort. “The clinical trial results show a promising medication as it showed potential benefits in terms of saving lives from a very lethal disease.”
He said the study also showed that a well-designed randomized study from a scientific perspective was ethically acceptable to American and African patients and health-care providers, and feasible to do during a difficult circumstance – in the middle of an outbreak.
Also participating in the study were Angela Hewlett, M.D., medical director of the Nebraska Biocontainment Unit (NBU), and Phil Smith, M.D., emeritus professor and former medical director of the NBU.
The study was led by the NIH and enrolled 72 participants in 2015. The participants came from Sierra Leone, Guinea, Liberia and the United States.
Investigators closed the study in January 2016 because they could not enroll additional patients, up to the targeted 200, because of the decline in the number of new Ebola cases as the outbreak diminished.