A recent study that included University of Minnesota School of Public Health researchers revealed potential benefits of ZMapp, an experimental immune-based treatment for Ebola studied within the PREVAIL II trial. The investigation built on previous drug research showing ZMapp was effective in non-human primates.
The results of the study were published in The New England Journal of Medicine.
The study was written by the PREVAIL II Group, which includes Professor James Neaton, Associate Professor Joseph Koopmeiners, and biostatistician Jacquie Neuhaus Nordwall. Several researchers in the school’s Division of Biostatistics also contributed to the study.
“This study provided useful safety and efficacy data from a well-done randomized trial on an experimental treatment for Ebola,” says Neaton. “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. Thirty-five patients received the standard of care, which produced a 37 percent mortality rate. Thirty-six patients received the standard of care as well as the drug, which produced a 22 percent mortality rate.
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. However, the difference did not reach statistical significance because the epidemic ended before a large enough number of infected patients could be enrolled in the study.
The investigators said the results of the study can still be considered promising and that there is a greater than 90 percent probability that the drug is effective.
“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,” says Neaton.