U.S., Liberia begin clinical trial to test Ebola drug ZMapp

The U.S. and Liberian governments on Friday launched a clinical trial to evaluate the safety and efficacy of an experimental Ebola drug called ZMapp, the U.S. National Institute of Allergy and Infectious Disease ( NIAID) said.

"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 Fauci, director of the NIAID, said in a statement.

"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, " Fauci said.

ZMapp, developed by California-based Mapp Biopharmaceutical Inc. , is composed of three different proteins called monoclonal antibodies that work to prevent the spread of the virus within the body.

Studies in nonhuman primates demonstrated that ZMapp has strong antiviral activity and rescued the animals from death as late as five days after Ebola infection, but there have been no human trials to support this due to limited quantities of the treatment.

In fact, the drug was administered only under emergency use authorization to nine Ebola patients in Africa, the United States, and Western Europe.

The trial, co-led by investigators at the NIAID and the Ebola Incident Management System in Monrovia, will enroll Ebola patients in Liberia, health care workers returning to the U.S. for treatment after Ebola infection, those who may have acquired Ebola infection in the U.S. through secondary transmission.

Participants will then be assigned randomly to one of two groups, the NIAID said. The first group, which will act as the control, will receive the current optimized standard of care, including providing intravenous fluids, balancing electrolytes, maintaining oxygen status and blood pressure and treating other infections if they occur.

The second group will receive the optimized standard of care plus three separate intravenous infusions of ZMapp administered three days apart. The total dose of ZMapp at each infusion will depend on the weight of the participant.

Study participants will be monitored up to 30 days following discharge from the hospital and may return for outpatient visits for additional follow-up, the NIAID said.

"Given the current decline in the number of new Ebola cases in Liberia, study investigators anticipate the need for flexibility in the conduct and design of the trial to address the changing nature of the outbreak in West Africa," the NIAID statement said. "Consideration will also be given to other sites in the outbreak region that express interest."

The trial is expected to conclude in December 2016.

So far, there have been more than 9,400 deaths since the Ebola outbreak began last year in Liberia, Sierra Leone and Guinea. The virus causes hemorrhagic fever in humans and currently has no approved therapy or vaccine. Endite