LOS ANGELES/LONDON – The first controlled trial of an experimental Ebola drug on humans has produced promising results.
Initial findings of the trial that ran through the second half of 2015 into January 2016 for the three-component antibody cocktail known as ZMapp showed that patients suffering from the potentially deadly Ebola Virus Disease (EVD) tolerated the drug well and that treatment response levels for those given the cocktail in addition to optimized standard-of-care (oSOC) were superior to patients in a control group provided only oSOC. Results were presented today at the Conference of Retroviruses and Opportunistic Infections in Boston.
Both groups were treated in identical conditions, with 24 of the 72 patients participating treated at International Medical Corps centers in Sierra Leone. Eight of the 36 patients receiving the ZMapp cocktail—22 percent--died during treatment, compared to 13 deaths, or 39 percent among the 35 patients who did not.
International Medical Corps Director of Ebola Research Adam Levine, who treated Ebola patients at the height of the outbreak in Liberia and Sierra Leone, described the results as “very exciting”.
“It’s the strongest sign yet that we may have a drug that can reduce mortality and save lives for patients infected with the Ebola virus,” said Levine, who is also an Assistant Professor of Emergency Medicine at Brown University Medical School. “That would be huge.”
At a more general level, he also noted the results showed that it was possible to conduct a randomized, controlled trial (RCT)--the gold standard globally for medical research--in the midst of a public health emergency.
When originally designed, the trial called for 200 participants, but less than half that number were enrolled as the world’s worst Ebola outbreak declined towards zero at the end of last year. The lack of sufficient numbers made it impossible to conclude from the trial results that treatment with the ZMapp cocktail was statistically superior to treatment without the drug. However, the nearly two-fold difference in mortality between those treated with the drug and those treated without the drug strongly suggests that it may be beneficial. Indeed, based on the study results, there is at least a 90 percent chance that ZMapp reduces mortality in patients infected with Ebola virus.
Even though the results were not statistically definitive, Levine said he expected they would be enough for physicians to use ZMapp in any future outbreak because of the dearth of alternatives. Levine noted that the ZMapp trial is the first randomized controlled trial in humans of any drug directed specifically at treating patients infected with Ebola.
The trial was sponsored by the National Institute of Allergy and Infectious Diseases, part of the U.S. Department of Health and Human Services’ National Institutes of Health, in partnership with government health entities of four nations, plus other academic, government and non-governmental agencies, including International Medical Corps.
International Medical Corps was one of the only humanitarian relief organizations to treat Ebola patients during the largest-ever Ebola outbreak—one that triggered a global public health emergency and claimed more than 11,000 lives before it was contained to just a few cases earlier this year. Most all fatalities occurred in the West African nations of Liberia, Sierra Leone and Guinea.
Since its inception more than 30 years ago, International Medical Corps’ mission has been consistent: relieve the suffering of those impacted by war, natural disaster and disease, by delivering vital health care services that focus on training. This approach of helping people help themselves is critical to returning devastated populations to self-reliance. International Medical Corps has delivered $2.2 billion in humanitarian relief and training in 75 countries since 1984. Today its global staff of 8,000 provides assistance to devastated communities in the world’s hardest-hit areas, from Syria to Sierra Leone, Iraq to Afghanistan. Visit us on Facebook and follow us on Twitter.