Officials in the small city of Dalton took a hard look at the steep trajectory of COVID-19 cases in their community early last month and decided that their 282-bed hospital needed help.
A bold idea emerged in the town known more for its pioneers in textiles than in public health. What if monoclonal antibody treatments — used to treat COVID-19 during the early onset of symptoms, to prevent severe illness and hospitalization — could be made more widely available? Maybe even in a drive-through setting, say, in the parking lot at the convention center?
In just a few weeks, that idea became reality, shepherded through by Dalton council member Annalee Harlan, a former paramedic who owns and operates a local hospice company.
Last November, when the Food and Drug Administration authorized Regeneron Pharmaceuticals’ monoclonal antibody for use in a narrow group of people considered at high risk to develop severe cases of COVID-19, doctors across the country debated whether it was worth the time and resources. The treatment was given by IV infusion, which could last up to three hours and had to to be administered in a health-care setting. Influential groups, including the National Institutes of Health and the Infectious Diseases Society of America, also balked at endorsing the treatment until full clinical trial data was available.
Credit: Curtis Compton / Curtis.Compton@
Credit: Curtis Compton / Curtis.Compton@
But studies have shown the treatment can be effective, and regulators have loosened the criteria for qualifying to include overweight people, which alone would make most people eligible; pregnant women; and those with a wide variety of illnesses including diabetes, hypertension and kidney disease.
And in June, a new way to administer the treatment became available: a series of injections. The injections make it easier to administer the therapy everywhere from mobile units to a drive-through clinic in Dalton.
Public health experts — as well as Dalton officials — stress that the treatment isn’t a substitute for vaccines. People still need to be vaccinated to receive the strongest protection against severe disease and hospitalization, they say.
But, if a person does contract COVID-19, the treatment could help prevent serious illness and reduce hospitalization by up to 70%, a new study by Mayo Clinic released this week found.
That could mean some desperately needed relief for Dalton’s Hamilton Medical Center and other hospitals throughout Georgia struggling to keep up with an influx of COVID-19 patients driven by the delta variant.
“These are the heroes, and we owe them everything,” Harlan said of the medical staff at Hamilton Medical Center. “I am not going to just say that. I am going to help keep people out of the hospital.”
Dalton’s drive-through clinic, which has an online appointment system, is intended to act like a “Band-Aid” while the push for vaccination continues, she said. Paramedics, emergency medical technicians from the Dalton Fire Department and other health care workers, including volunteer nurses, administer the treatment.
No doctor referral for the Dalton drive-through is needed, only a positive COVID-19 test result. For those who have symptoms but don’t know if they are positive, rapid tests are available onsite. The treatment consists of four injections — all given during the same visit — either in the abdomen, back of the arm or thigh. It’s authorized for people 12 and older with mild to moderate symptoms and must be administered within 10 days of onset. The idea is to stop the virus before it becomes a problem.
Credit: Curtis Compton / Curtis.Compton@
Credit: Curtis Compton / Curtis.Compton@
Dr. Anthony Fauci, the White House’s chief medical adviser, has described monoclonal antibodies as a “much-underutilized intervention” for COVID-19 and is encouraging its use and availability.
Still, very few primary care doctors or urgent care centers in Georgia are offering it right now, and most refer patients to hospital-affiliated clinics for the treatment.
Georgia Department of Health spokesperson Nancy Nydam said the agency is exploring options to make monoclonal antibody treatment more accessible, but she didn’t offer any specifics. There are currently 136 locations in Georgia where monoclonal antibody treatment is available, according to the state health department.
Dr. Thomas Bat — CEO of North Atlanta Primary Care, a large practice with 16 clinics throughout metro Atlanta — said plans are in the works to begin administering the treatment at a couple of their clinics in the upcoming weeks.
“The need for monoclonal antibody treatment has skyrocketed over the past six weeks and, if we can take some of the load off the hospitals and deliver this, we want to do that,” Bat said.
‘A game-changer’
COVID-19 struck Greg Land hard and fast.
Within two days of testing positive for the coronavirus, Land, who was unvaccinated, had chest tightness and struggled to catch his breath.
Then a relative in Dalton told him about monoclonal antibodies — a still largely unfamiliar COVID-19 treatment. Land was on day five of symptoms.
Within 24 hours of the injections, Land said, his body chills and chest tightness started easing. And little by little, he’s improved. Now, a little over a week since the treatment, he says he’s close to 100%.
“You know when it’s not going well, and I knew I was heading in the wrong direction,” said Land, a 50-year-old engineer who lives just across the Georgia state border in Tennessee. “The treatment was a game-changer. I have no doubt, if I didn’t get the treatment, I would have ended up in the hospital.”
Dr. Kathy Hudson, chief medical officer at Phoebe Putney Memorial Hospital in Albany, said patients there have had similar experiences.
“We have seen tremendous benefits,” Hudson said. “It is not a cure, but these antibodies can help kick start the immune system. We have so many COVID-19 patients right now. I hate to think how many we would have without this treatment.”
Credit: Curtis Compton / Curtis.Compton@
Credit: Curtis Compton / Curtis.Compton@
Dr. Andrew Reisman, a family doctor in Gainesville and past president of the Medical Association of Georgia, said he’s seen mixed results from the treatments. He recently referred a middle-aged woman who was unvaccinated. But, despite the treatment, she ended up hospitalized. A vaccinated woman in her 80s, who had a breakthrough case and has multiple chronic health conditions, appears to have responded well. She was briefly hospitalized.
“I saw her today, and she seems to be doing quite well. I feel pretty good about the fact she got it,” he said.
Monoclonal antibodies are produced in a laboratory and designed to recognize a specific component of this virus — the spike protein on its outer shell. In the body of a COVID-19 patient, they give the immune system a leg up until it can mount its own response. But again, doctors are quick to say these lab-grown antibodies are no substitute for COVID-19 vaccinations.
One key drawback of monoclonal antibodies is that they can lose their effectiveness against new variants. Researchers are working to develop new monoclonal antibodies resistant to variants.
For health care facilities, another obstacle is that the therapy is time- and resource-intensive. Whether given intravenously or via injection, the process can take as many as two or three hours. After administering the shots, the patient must be monitored for an hour to watch for any signs of an allergic reaction.
Also, because COVID-19 patients are highly contagious, they must be kept separate from other vulnerable patients.
Despite these extra layers of complexity, hospitals across the state have turned old office space and areas near emergency rooms into special infusion centers or dedicated spaces for the injections.
Credit: Curtis Compton / Curtis.Compton@
Credit: Curtis Compton / Curtis.Compton@
Piedmont Healthcare offers the treatment at six hospital locations in Georgia, including two in metro Atlanta and one in Athens and Columbus.
Scott McAuley, executive director of pharmacy of Piedmont Healthcare, said at the pandemic’s peak in the winter, the staff was treating about 250 every week. They are now down to about two-thirds of that level with about 175 patients a week.
At Phoebe, the hospital system is installing a modular building for antibody infusions across the street from the main Emergency Room department. The idea is to be able to directly send patients coming into the ER for immediate antibody treatment.
Benny Dunn and his wife, Dianne, both received monoclonal antibody treatment in Dalton recently for breakthrough COVID-19 cases. The couple, both in their 70s, were fully vaccinated in early February. Dianne Dunn who has several underlying health conditions, experienced symptoms first and had monoclonal antibody treatment at a hospital. Benny Dunn felt symptoms a couple of days later. He was treated at Dalton’s drive-through clinic.
“I had a low-grade fever and headache and congestion,” said Dunn, who is the city’s interim public works director. “And, within 24 hours later, the pressure was gone.”
He said his wife is also on the mend.
“I see the vaccine and monoclonal antibody treatment as a one-two punch,” said Dunn. “I think, if we hadn’t gotten vaccinated and if we hadn’t gotten the treatment, we would not have done so well.”
What you need to know about monoclonal antibody treatment
Monoclonal antibody treatment, which has emergency use authorization, is for non-hospitalized COVID-19 patients 12 and up with mild to moderate symptoms.
The treatment must be given within 10 days of first symptoms — the earlier the better.
A doctor’s referral is usually required.
Patients are evaluated before getting the treatment to make sure they still meet the requirements and are not too sick.
While the federal government is covering the costs of the doses of medication, medical centers can charge insurance companies, as well as Medicaid and Medicare, the costs of administering the treatment.
There are currently 136 locations in Georgia where monoclonal antibody treatment is available. Go to the HHS Protect Public Data Hub website to find a location.
In another development in July, the FDA expanded its emergency authorization of the Regeneron treatment so it could be used to try to prevent COVID-19 in a small number of high-risk people. This includes people with certain health conditions who are not vaccinated and who have been exposed to the virus and people who live in nursing homes.
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