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Phase 1 trial of ZMapp begins
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A clinical trial to determine the safety and efficacy of the investigational Ebola virus treatment ZMapp has been launched by the National Institute of Allergy and Infectious Diseases and the government of Liberia, according to a press release.
“Although ZMapp has been used to treat several Ebola-infected patients in recent months, we cannot determine if the drug actually benefited those patients because it was not administered within the context of a clinical trial,”Anthony S. Fauci, MD, director of the NIAID, said in a press release. “This clinical trial will help us determine if ZMapp and other treatments are safe and effective for use in the current devastating outbreak in West Africa as well as in future outbreaks.”
Anthony S. Fauci
Conducted in Liberia and the U.S., the randomized controlled trial with enroll consenting adults and children of any age who have already acquired the infection. Participants in both the treatment and control group will receive optimized standard of care, including IV fluids, balancing electrolytes, maintaining oxygen and blood pressure, and infection control. The patients will be monitored for 30 days following discharge.
The framework for this study will be used to study other potential Ebola treatments being developed for the future. It is expected to conclude in December 2016.