The U.S. Department of Health and Human Services and the El Centro Regional Medical Center today began administering monoclonal antibody therapeutic treatments at a temporary COVID-19 infusion center in Imperial County, California. The center is the first in a pilot program to treat certain COVID-19 patients in order to prevent hospitalization and the severity of illness.

The center will treat patients who have tested positive for COVID-19 and are at high risk of severe illness or hospitalization. Patients at the infusion center will receive one of two monoclonal antibody therapeutics authorized by the U.S. Food and Drug Administration (FDA), either one from Eli Lilly and Company which uses the monoclonal antibody bamlanivimab or one from Regeneron which combines the two monoclonal antibodies casirivimab and imdevimab.

“Like many hospitals across the country, El Centro Regional Medical Center is caring for an extremely high number of patients who have developed severe cases of COVID-19,” said Assistant Secretary for Preparedness and Response Dr. Robert Kadlec. “At this infusion center, a federal medical team will be on hand to provide therapeutic treatments that can keep people from becoming so sick that they need to be hospitalized, which will help reduce the stress on the hospital, particularly the ICU, and help save lives.”

“In our fight against COVID, adding a tool in our toolbox we call therapies to include the infusion center is going to be a win-win for this community,” said Chief Executive Officer of El Centro Regional Medical Center Dr. Adolphe Edward. “We are finally going to be able to actually treat patients at an early stage that might have had COVID and now we can actually see that besides vaccines and therapeutics we are going to win this battle.”

The medicines are administered through an intravenous (IV) infusion treatment. The infusion of the therapeutic and medical observation together take approximately two-and-a-half hours. At El Centro Medical Center, patients who meet the criteria will be treated with the therapeutic by a team of medical professionals from the National Disaster Medical System (NDMS).

Both products can be used to treat adults and pediatric patients (12 years of age and older weighing at least 40 kg) who have positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. High risk adults meet at least one of the following criteria:

• Have a body mass index (BMI) of 35 or greater;

• Have chronic kidney disease;

• Have diabetes;

• Have immunosuppressive disease;

• Are currently receiving immunosuppressive treatment;

• Are 65 years of age or older.

FDA defines high risk differently for children; that definition is available on the FDA website.

Patients who test positive for COVID-19 and meet the criteria can be referred by their medical provider to receive the infusion treatment. In El Centro, California, patients who have a positive COVID-19 test and are referred by their doctor or who receive a positive COVID-19 test in the El Centro Regional Medical Center emergency room can be referred to the infusion center to receive the treatment within ten days of testing positive.

Monoclonal antibody treatments have been shown to decrease hospitalization rates in people at highest risk for severe disease from COVID-19. This therapy requires an infusion within the first 10 days after diagnosis, which may require healthcare systems to create new clinical pathways to administer the medicine to patients at the highest risk of developing severe cases of COVID-19.

In November, the FDA issued emergency use authorizations (EUA) to permit the emergency use of two monoclonal antibody therapeutics to treat mild to moderate coronavirus disease 2019 (COVID-19) in non-hospitalized patients: bamlanivimab from Eli Lilly and Company was authorized for emergency use on Nov. 9, and Regeneron’s therapeutic was authorized on Nov. 21.

Working with the Department of Defense, HHS is partnering with multiple companies to develop, manufacture, and make available therapies to treat COVID-19. To learn more about the monoclonal antibody therapeutic treatments ASPR has purchased and currently is allocating nationwide, visit phe.gov.

About NDMS:

Since January, ASPR has deployed over 1,400 of medical, logistical, and command and control personnel from NDMS to help states, territories, and jurisdictions respond to the COVID-19 pandemic. These deployed personnel include physicians, physician assistants, nurses, respiratory therapists, paramedics, pharmacists, and behavioral health specialists who serve as intermittent federal personnel. When not deployed, they are the medical and support professionals serving in private sector healthcare jobs in communities across the country, in whom Americans entrust our health on a day-to-day basis. Currently, NDMS teams – along with healthcare providers from U.S. Public Health Service Commissioned Corps – are providing surge support at several hospitals or long-term care facilities in multiple states.

About HHS and ASPR:

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. To learn more about federal support for the all-of-America COVID-19 response, visit coronavirus.gov.

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