The giant, tarp-covered tent staked in the middle of the Mountain Area Health Education Center parking lot looks like something astronauts might set up on the moon. But instead of space suits, the doctors and nurses entering the pressurized, white-domed bubble are wearing head-to-toe personal protective equipment, ready to administer monoclonal antibody infusions to high-risk COVID-19 patients.
Inside the tent, it feels like a “warm and comfortable nurses’ station,” says Dr. Rebecca Bernstein, the physician overseeing MAHEC’s new bamlanivimab infusion program. COVID-19 patients experiencing mild to moderate symptoms enter in waves. A team member explains the process, and a few minutes later, an IV is placed in each patient’s arm, slowly dripping highly targeted coronavirus antibodies into the bloodstream.
By some metrics, the country is turning a corner on the COVID-19 pandemic. New cases are dropping across the United States — North Carolina’s Department of Health and Human Services reported just over 3,000 new cases on Feb. 8, down from more than 11,500 cases on Jan. 9 — and vaccine distribution, while still limited, is underway. Treatments to lower the risk of serious symptoms in infected individuals are also improving and becoming more widely available.
Two monoclonal antibody therapies manufactured by drug companies Eli Lilly and Regeneron received emergency use authorization by the U.S. Food and Drug Administration in November for COVID-19 patients at risk of developing severe illness and requiring hospitalization. Now, the therapies former President Donald Trump touted as the “cure” for COVID-19 following his October hospitalization are available on a limited basis for Western North Carolina residents.
“With the surge in patients that we’re seeing, we need whatever tools we can get to decrease the impact this virus has on our community,” Bernstein says. “This is the one outpatient treatment that has been shown to decrease the severity of the disease.”
Monoclonal antibodies are laboratory-made proteins that mimic proteins produced by the immune system to fight off harmful viruses and other foreign threats. As with the COVID-19 vaccine, the drugs stimulate the body to mount a stronger immune response and destroy the coronavirus before it causes damage. Early data suggests the drugs may reduce hospitalizations in people at high risk for severe complications by 70%; late-stage clinical trials are ongoing.
Unlike the convalescent plasma taken from recovered COVID-19 patients, which contains all of the different antibodies a donor has developed, monoclonal antibody therapies only contain the specific antibody (or, in the case of the Regeneron cocktail, two antibodies) targeted at a protein on the SARS-CoV-2 virus. Treatments must be given within 10 days of symptom onset, and patients who are already hospitalized with the virus or who require oxygen are not authorized for treatment.
At MAHEC, patients age 55 and older with cardiovascular disease, hypertension or chronic obstructive pulmonary disease are eligible for antibody therapy with a doctor’s referral. Younger patients with a body mass index over 35, chronic kidney disease, diabetes or an immunosuppressive disease may also qualify, as can those over the age of 65 without preexisting conditions. The therapy takes about an hour to administer, Bernstein says. Patients are then monitored for any adverse reactions for up to an hour after the infusion.
Thanks to a deal struck by the federal government, doses are free, although some patients may be charged for the drug’s administration. In November, Medicare waived all copayments for administration costs. Blue Cross Blue Shield of North Carolina, the state’s largest private provider, has also waived all member cost-sharing for COVID-19 treatments through Wednesday, March 31.
Despite the drug’s early success, supplies remain extremely limited. The federal government controls the distribution of 950,000 doses of Eli Lilly’s bamlanivimab and 300,000 doses of Regeneron’s casirivimab/imdevimab; state health departments are sent allocations from the federal supply every two weeks for distribution to local providers. The U.S. Department of Health and Human Services has also developed a program to directly send monoclonal antibody doses to long-term care facilities, dialysis centers and federally qualified health centers.
Pardee is one of the busiest hospitals in the UNC Health system for treating patients with the Eli Lilly and Regeneron monoclonal antibody infusions, said Chris Parsons, medical director of the Pardee Center for Infectious Diseases, although he did not specify how many infusions have been administered at the facility. The hospital is working closely with the Henderson County Department of Public Health, the Henderson County Emergency Medical Services team, long-term care facilities and community providers to identify potential candidates for the drugs, he wrote in an emailed statement.
AdventHealth Hendersonville also offers both infusions, says Chief Medical Officer Teresa Herbert. The hospital accepts referrals from any practice, long-term care facility or urgent care, though staff can only treat four patients a day due to limited supply and space constraints. Negative pressure rooms — facilities that constantly pump potentially contaminated air away from other patients — are required to give the infusions, she says, and these rooms are often in short supply.
All monoclonal antibody therapies received by Mission Health were sent to MAHEC to support the infusion tent program, noted Mission spokesperson Nancy Lindell in a statement. As of Jan. 28, MAHEC had completed 24 infusions since the program’s official launch on Jan. 19.
Blue Ridge Pharmacy, a long-term care pharmacy provider, is also receiving federal allocations of the antibody infusions for use at regional nursing homes and long-term care facilities, says Dave Phillips, the pharmacy’s director of clinical services. Citing patient privacy concerns, he would not share the names of those facilities or how many infusions had been sent to area nursing homes, but he says Blue Ridge has seen a surge in interest over the last few weeks.
“No medication comes without risks, but there’s promising data coming out as we continue studying and learning more about these monoclonal antibodies and their impacts on COVID,” Phillips says.
Flat Rock resident Debi Brown began to feel sick on Jan. 2. By the next morning, the 61-year-old felt as if she had been “run over by a truck.”
Brown drove to nearby Pardee Hospital for a COVID-19 test. As she waited, she began talking to a physician’s assistant about her husband, Larry, who is 72 years old and has a history of heart failure, high blood pressure and asthma. His age and health history placed him at high risk for serious COVID-19 symptoms, Brown says — but they also made him eligible for an antibody treatment.
The next morning, following a positive rapid test for COVID-19, Larry got his monoclonal antibody infusion. Within 48 hours, he was feeling completely normal. Brown, however, says she “went through the wringer.” Despite having several heart conditions herself, she was told her age disqualified her from getting the same therapy. She later developed pneumonia, and nearly a month after her diagnosis, she’s still experiencing shortness of breath, a deep cough and a diminished sense of smell.
Before her bout with the coronavirus, Brown says she didn’t know that monoclonal antibodies were available in the area. But she believes her husband’s infusion was likely the difference between a mild illness and a life-threatening hospitalization.
“This stuff is amazing, and people need to know about it,” Brown says. “They need to ask for it, if they can. It works, and it can help stop this disease before more people end up dying left and right.”