Potential Ebola treatment falls short of statistical efficacy threshold: 4 insights

ZMapp, a triple monoclonal antibody cocktail, did not meet the prespecified statistical threshold for efficacy for Ebola virus disease treatment, according to a study in the New England Journal of Medicine.

Researchers conducted a randomized, controlled trial in patients with the Ebola virus. Patients were divided into two groups — one was treated using the current standard of care plus ZMapp while the other was treated using only the current standard of care. The primary end point was mortality at 28 days.

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A total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea and the United States.

Here are four insights:

1. Of the 71 patients who could be evaluated, 21 died, representing an overall case fatality rate of 30 percent.

2. Thirteen of the 35 patients who received only the current standard of care died.

3. Eight of the 36 patients who received the current standard of care plus ZMapp died.

4. The observed posterior probability that ZMapp plus the current standard of care was superior to the current standard of care alone was 91.2 percent.This figure falls short of the prespecified threshold of 97.5 percent.

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