McLeod Health, HHS partner to expand access to monoclonal antibody therapy for COVID-19 patients

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With the rapid spread of the delta variant and only 45 percent of the population fully vaccinated for the coronavirus, the state of South Carolina is in the midst of a major surge in COVID-19 cases. As of Aug. 9, the state is averaging more than 2,500 cases per day during the past week, up from roughly 200 cases per day a month ago.

In response, McLeod Health, in partnership with the South Carolina Department of Health and Environmental Control and U.S. Department of Health and Human Services, has expanded access to COVID-19 monoclonal antibody (mAb) treatment at multiple locations: McLeod Health Clarendon, McLeod Regional Medical Center, McLeod Health Seacoast and McLeod Health Loris.

For people who are at high risk for developing severe COVID-19 illness and have tested positive for the COVID-19 virus, this promising mAb treatment has been shown to help prevent progression of the disease that might otherwise require hospitalization.

If administered within 10 days of onset of COVID-19 symptoms, the one-time therapy is highly effective in neutralizing the virus and preventing symptoms from worsening. The treatment is administered through intravenous infusion.

"We are pleased to be a part of this important initiative and are committed to ensuring that the most vulnerable individuals in our community have access to COVID-19 care," said Dr. Dale Lusk, corporate chief medical officer and senior vice president of quality and safety for McLeod Health. "Monoclonal antibody treatments have been offered to COVID-19-positive patients at McLeod Health since November of 2020, and continuing to provide this service ensures that we play a pivotal role in helping our region and state recover from this pandemic."

"We know that this treatment can save numerous lives. With the delta variant again increasing numbers across our state, it is a vital tool to help our patients recover and also curb further spread of COVID-19," he continued.

"South Carolina is seeing a surge in the number of COVID-19 cases that is impossible to ignore, and the delta variant is driving it," said Dr. Brannon Traxler, public health director at the South Carolina Department of Health and Environmental Control. "Until we defeat COVID-19, there will continue to be more and more people who find themselves infected, which is why it is so vitally important to have monoclonal antibody therapy treatments available and partners like McLeod Health invested in serving families in underserved areas of South Carolina."

On March 17, HHS announced it was investing $150 million to increase access to mAb therapy for high-risk patients in underserved and disadvantaged communities across the country. With support from KPMG LLP, HHS is developing new prototype models for expanding access to mAb treatment and leveraging an existing network of health care partners to provide the therapy for underserved and disadvantaged populations.

McLeod is the first provider organization in South Carolina to join this health equity initiative and joins a growing list of mAbs therapy providers supported by KPMG and sponsored by HHS as part of the federal effort to help end COVID-19 and improve health equity in underserved communities across the country.

In addition to the four sites in South Carolina, more than 30 infusion sites have now been established or expanded under this initiative in Landover, Maryland; San Diego, California; Detroit, Michigan; Barnstable County, Massachusetts; Houston, Texas; Beckley, West Virginia; Worcester, Massachusetts; western Michigan; and southern Missouri.

"People across the country continue to test positive for COVID-19, and many of them are still at great risk of severe hospitalization and even death from this virus," said Dr. John Redd, chief medical officer for the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. "We encourage anyone who tests positive for COVID-19 to discuss with their health care provider if monoclonal antibody treatment is right for them. We are pleased to partner with leaders in the medical community, like McLeod Health, to make this treatment more accessible."

The therapy is the first COVID-19 treatment granted emergency use authorization by the U.S. Food and Drug Administration for outpatient use. A Phase 3 clinical trial showed that the antibody therapy reduced the risk of hospitalization or death by up to 70% in patients who received the drug intravenously compared to those who received a placebo.

To be eligible for mAb treatment, patients must meet the Emergency Use Authorization (EUA) definition of "high risk." Same-day COVID-19 tests can be performed, followed by a telemedicine visit for evaluation and qualification for therapy. Following completion of the infusion treatment, patients are monitored onsite for an hour. Treatment is offered regardless of immigration status, health insurance coverage or ability to pay.

To confirm eligibility for the treatment, receive a referral and book an appointment, patients should go online at www.McLeodCovid.org or contact the McLeod Health COVID Call Center at (843) 777-2919 for more information. A copy of the patient's positive test result is required to schedule an appointment.