Tuesday, October 2, 2018

Massachusetts General Hospital to participate in clinical trial evaluating experimental treatment for Ebola Virus Disease

Study participation is latest effort by hospital to enhance biothreats preparedness

Massachusetts General Hospital (MGH) announced today that it will take part in an international multi-center trial evaluating ZMapp™, an experimental treatment consisting of three antibodies to treat Ebola Virus Disease (EVD). ZMapp was previously studied in West Africa and the United States during the 2014-2016 Ebola outbreak and is currently being made available under an Expanded Access Protocol (EAP) in the U.S. and Africa. The EAP is designed to provide patients who have confirmed EVD and/or high-risk Ebola Virus exposure access to ZMapp and to provide further safety and pharmacokinetic characterization of ZMapp.

“While there are currently no patients with Ebola in the United States, having ready access to experimental therapeutics such as ZMapp has been a priority for MGH, in our role as the Regional Ebola and Other Special Pathogens Treatment Center (RESPTC),” says Erica Shenoy, MD, PhD, associate chief of the MGH Infection Control Unit, medical director of hospital’s Biothreats Care Unit, and the study’s local principal investigator. “In recent years we’ve seen an increased push to find effective treatments, and we recognize the importance of contributing to those efforts by making ZMapp available to patients if needed and advancing its further study.”

In 2014 and 2015 West Africa saw a major deadly outbreak of EVD with cases also confirmed in Europe and the United States. According to the World Health Organization, the Centers for Disease Control and Prevention and local ministries of health data, affected areas saw more than 28,000 laboratory-confirmed and probable cases and more than 11,000 deaths. Currently, in the on-going outbreak in Democratic Republic of the Congo, ZMapp has been deployed along with other experimental medical countermeasures.

“MGH is committed to delivering the best and safest care possible to anyone infected with these very serious kinds of pathogens.  We are extremely excited to participate in this protocol and to be able to offer this therapy if we are ever asked to care for a patient with Ebola,” says Paul Biddinger, MD, director of the Center for Disaster Medicine and chief of the Division of Emergency Preparedness in the Department of Emergency Medicine.

Through participation in the protocol, patients who meet criteria for enrollment at MGH will be provided ZMapp and their clinical responses studied. Working with a team from the hospital’s Center for Disaster Medicine, Pharmacy, laboratory staff, and clinicians, Shenoy and co-investigator Ana Weil, MD, MPH, from the hospital’s Division of Infectious Diseases, have developed administration protocols and led trainings on the process for administration of the therapeutic.

“Participating in a study of this nature requires a great deal of preparedness and planning," says Shenoy. “It’s critical to not only have clinical expertise but the commitment, training, infrastructure and planning to treat a patient with EVD or other pathogens that have limited or no treatment options and require enhanced infection control interventions to ensure the safe delivery of care."

The ZMapp Expanded Access Protocol is a collaboration with the National Ebola Training and Education Center’s Special Pathogens Research Network (SPRN). The SPRN is made up of representatives from the 10 RESPTCs across the United States. Ultimately, all 10 RESPTCs are expected to have the ZMapp EAP in place.

In 2015 MGH was designated as an RESPTC by the U.S. government and as part of this designation conducts numerous annual trainings and planning sessions. To qualify, centers were required to ensure their physical facilities were prepared for the complexities of treating up to two patients with EVD and ensure that staff – clinical and non-clinical alike – are trained and ready to respond should a case present itself. As an RESPTC, MGH is also committed to caring for patients with other emerging infectious diseases such as Middle East Respiratory Syndrome and avian influenza. MGH shares expertise, training, and other activities with the nine other RESPTCs in the nation through the National Ebola Training and Education Center.

This project has been funded in whole or in part by the United States Government with funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Assistant Secretary, Department of Health and Human Services, under Contract No. HHSO100201600021C. The MGH Regional Ebola and Other Special Pathogens Treatment Center is supported through the ASPR Hospital Preparedness Program, Ebola Preparedness and Response Grant.

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $900 million and major research centers in HIV/AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, genomic medicine, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, photomedicine and transplantation biology. The MGH topped the 2015 Nature Index list of health care organizations publishing in leading scientific journals and earned the prestigious 2015 Foster G. McGaw Prize for Excellence in Community Service. In August 2018 the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America's Best Hospitals."

 

Media contact: Mike Morrison, mdmorrison@partners.org, 617-724-6425.

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