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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