January 08, 2021
The U.S. Department of Health and Human Services (HHS) and Sunrise Hospital & Medical Center today began administering monoclonal antibody therapeutic treatments at a temporary, physician referral-based COVID-19 infusion clinic in Las Vegas, Nevada. The center is the third federally supported infusion clinic to treat certain COVID-19 patients in order to prevent hospitalization and the severity of illness. The first center opened in El Centro, California, December 30, and the second center opened in Tucson, Arizona, last week.
The Sunrise Hospital Monoclonal Antibody Clinic will treat patients who have tested positive for COVID-19 and are at high risk of severe illness or hospitalization. Patients at the monoclonal antibody infusion clinic will receive Eli Lilly’s bamlanivimab approved by the U.S. Food and Drug Administration (FDA) for emergency use on November 9, 2020.
“Like many health care facilities across the country, Sunrise Hospital & Medical Center is caring for an extremely high number of patients who have developed severe cases of COVID-19,” said HHS Assistant Secretary for Preparedness and Response (ASPR) Dr. Robert Kadlec. “At this infusion center, a federal medical team of 11 providers is partnering with Sunrise Hospital to administer monoclonal antibody 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.”
“The monoclonal antibody therapeutics being used at the Sunrise Hospital clinic have been demonstrated as safe and effective in clinical trials when administered under FDA guidance. These infusion treatments keep the virus from attacking the human body and are most effective for symptoms that are mild or moderate,” said David Wuest, Executive Secretary of Nevada State Board of Pharmacy. “Treating these patients successfully will reduce the strain on the capacity of hospitals and free up resources for the more severe COVID-19 patients. This infusion center is another important milestone in our State’s battle to end the pandemic and save lives.”
“Sunrise Hospital & Medical Center has been battling the COVID-19 pandemic since our first case appeared in March of last year,” said Chief Executive Officer Todd P. Sklamberg. “Today, all of us at Sunrise Hospital are proud to have been chosen as the third site in the country for operation of the federally supported and temporary Sunrise Hospital Monoclonal Antibody Clinic. This multi-government agency partnership between federal, state, county, and the private sector is amazing – all of us working together to save lives from COVID-19 here in our Las Vegas community. It is our sincere hope the Monoclonal Antibody Clinic will touch many lives, reducing need for hospitalization, and serve as a model for healthcare facilities across the United States.”
The medicine is administered through an intravenous (IV) infusion treatment. The infusion of the therapeutic and medical observation together take approximately two-and-a-half hours. At Sunrise Hospital & Medical Center, patients who meet the emergency use authorizations (EUA) criteria will be treated with the therapeutic by a team of medical professionals from HHS’ National Disaster Medical System (NDMS).
Bamlanivimab can be used to treat adult patients 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.
- Are 55 years of age or older AND have:
- Cardiovascular disease, or
- Hypertension, or
- Chronic obstructive pulmonary disease/other chronic respiratory disease.
Patients who test positive for COVID-19 and meet the EUA criteria can be referred by their medical provider to receive the infusion treatment. In Nevada, providers can directly refer patients with a positive COVID-19 test who meet the EUA criteria to the Sunrise Hospital Monoclonal Antibody Clinic to receive the treatment within 10 days of testing positive. Referring medical providers may call (702) 961-9075 to schedule the patient.
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 EUA to permit the emergency use of two monoclonal antibody therapeutics to treat mild to moderate COVID-19 in non-hospitalized patients: bamlanivimab from Eli Lilly and Company was authorized for emergency use on November 9, and Regeneron’s therapeutic was authorized on November 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 Public Health Emergency's website.