UMN Researchers Collaborate on Ebola ZMapp Clinical Trial Published in NEJM
A recent study in the New England Journal of Medicine revealed potential benefits of ZMapp, an experimental immune-based treatment for Ebola studied within the PREVAIL II trial.
Previous research has shown that ZMapp was effective in non-human primate studies.
The study, published in the New England Journal of Medicine, was written by the PREVAIL II Group. James Neaton, Ph.D., Joseph Koopmeiners, Ph.D., and Jacquie Neuhaus Nordwall, M.S., of the School of Public Health, are all part of the writing group for the study, and cited authors. Several researchers in the Division of Biostatistics also contributed to the study. Koopmeiners is also a Masonic Cancer Center member.
Two University of Minnesota physicians, David Boulware, M.D., M.P.H., and Hope Pogemiller, M.D., M.P.H., of the Medical School, also participated in the study group. Pogemiller and Quy Ton, a physician who worked for the University in 2015, spent several months in West Africa collecting data.
“This study provided useful safety and efficacy data from a well-done randomized trial on an experimental treatment for Ebola,” Neaton said. “While missing statistical significance, the data were sufficient to lead the drug (ZMapp) to be recommended for emergency use if there is a future epidemic.”
The controlled, randomized trial spanning March to November 2015 involved 72 Ebola patients from Sierra Leone, Guinea, Liberia and the United States. 35 patients received the standard of care, which produced a 37 percent mortality rate. 36 patients received the standard of care as well as the drug, which produced a 22 percent mortality rate (One person left the study early).
According to the National Institutes of Health (NIH), the relative difference in mortality between the two groups was 38 percent lower for those who received ZMapp. The difference did not reach statistical significance.
“I would view the results from this study in an optimistic light. We were able to show that there was a greater than 90% probability that the drug had efficacy,” Richard Davey, M.D., told CIDRAP news. Davey is the deputy clinical director of the National Institute of Allergy and Infectious Diseases (NIAID), and the lead author on the study.
“It also established that one can conduct a properly designed randomized trial in a very difficult setting: the setting of an epidemic and a setting with very limited resources,” Neaton said.