On the last day of November, Bill Collins wakes up in the middle of the night, sweating profusely, his heavy pajamas clinging to his body. He’s disoriented, shivering, unsteady on his feet. His wife considers calling an ambulance.
But hours before, at Floyd Medical Center, Collins had received an infusion of a monoclonal antibody drug, a new treatment designed for COVID-19 patients at high risk for developing complications which could lead to hospitalization.
Credit: Ryan Smith for the AJC
Credit: Ryan Smith for the AJC
When Collins, the former mayor of Rome, Ga., climbed out of bed the next morning, he felt slightly better. And over the next several days, he improved, little by little— the cough, muscle aches, chills easing up.
“When you are sick as I was, you look for anything to give you hope. And for me, it was the treatment,” said Collins, who is in his mid-60s and has diabetes.
Meanwhile, his wife, Faith, who also received the treatment but had less severe symptoms, saw remarkable improvement. She was almost entirely better within three days.
Monoclonal antibodies are lab-made drugs designed to mimic natural antibodies to the virus that causes COVID-19. They are currently the only therapy authorized by the Food and Drug Administration for people who are not hospitalized. While more, larger studies of the treatment’s effectiveness are needed, early results have been encouraging. There is also a vast supply of the drugs.
So far, though, the treatment has not seen widespread use because of the challenges it creates for hospitals.
Administering monoclonal therapy is complicated, time-and-resource intensive. The antibodies are given intravenously in an hour-long infusion and take three to four hours overall to administer and monitor.
And because COVID-19 patients are highly contagious, they must be kept separate from other vulnerable patients, such as those getting infusions for chemotherapy.
That adds to the burden of hospitals, whose beds are filled with COVID-19 patients and whose health care workers are also busy delivering the first vaccines.
Another complicating factor is some people have been reluctant to leave their homes for treatment, especially if they don’t feel so bad. Yet the therapy must be given early in the course of their illness, within seven to 10 days of first developing symptoms, and a positive COVID-19 test is also required.
“When you are sick as I was, you look for anything to give you hope. And for me, it was the treatment."
- Bill Collins, who received an infusion of a monoclonal antibody drug
Despite these extra layers of complexity, hospitals across the state are turning old office space, hospital rooms or areas near an emergency room into special infusion centers so they can ramp up use of the treatment.
The major and persistent obstacle is staffing.
“We had the space and the stuff, but we didn’t’ have the staff to administer it,” acknowledged Dr. Danny Branstetter, medical director of infection prevention for Wellstar Health System.
The system has been able to provide a limited number of treatments at its hospitals but to expand access, it is working with nursing homes so their staffs can provide the treatments. Wellstar is also partnering with home health nurses to administer the infusion in patients’ homes, and it is working on a plan to team up with EMS workers to do the same beginning next month.
Piedmont Healthcare figured out ways to offer the treatment in Athens and Columbus in December and added two spaces in metro Atlanta earlier this month. Now, the hospital system is treating about 250 patients every week.
‘This is huge’
The FDA granted emergency use authorization to two drug makers — Eli Lilly and Regeneron —for their monoclonal antibody treatments in November.
Shortly afterward, Dr. Daniel Valancius, medical director of Floyd Medical Center’s hospitalist program, went to the hospital’s chief medical officer.
“We were at the peak of the height of the pandemic, and I said, ‘Let’s do more stuff,’” Valancius said.
He knew it was a big ask, but Valancius was encouraged by a growing number of small studies showing the therapy could help keep people out of the hospital and save some lives. Hospital leadership was on board.
“As someone who sees patients in the ICU, this is huge for me. If I have a mom and I am not having to Facetime her family before putting her on a vent, but she is able to be with her family, we are talking about someone in our community, and that is deeply personal for me.”
By late December, 100 people received the treatment, and some were likely saved, said Dr. Ken Jones, executive vice president and chief medical officer at Floyd Medical Center.
“I thought about the one or two people who should have died, at home opening Christmas gifts,” said Jones. “That was a real strong take home for me and Dan.
“We need positive things. Our staff is burned out, and this has been a highlight. And our team has moved mountains to make this successful.”
That has meant not only overcoming logistical challenges at times but also having health care workers work late to give the treatments.
‘Is it worth it?’
When FDA authorized the treatment, doctors across the country debated whether it was worth the time and resources.
Treatment guidelines by The National Institutes of Health indicated there is not enough proof to recommend its use. And the Infectious Diseases Society of America recommended against routine use because of insufficient proof that it works.
As more patients are treated, however, there’s growing evidence that the therapies can keep some high-risk patients out of the hospital.
“As someone who sees patients in the ICU, this is huge for me."
- Dr. Daniel Valancius, medical director of Floyd Medical Center’s hospitalist program
An early analysis of a phase 2 clinical trial involving Eli Lily’s bamlanivimab found hospitalization during the 28 days after the antibody therapy was 3%, compared with 10% of patients who received placebos. Regeneron’s results were similar.
Dr. Raymund Razonable, a professor of medicine and principal investigator of monoclonal antibody studies at the Mayo Clinic in Rochester, Minn., has overseen more than 3,000 monoclonal antibody infusions across Mayo’s centers nationwide.
While his research is not yet completed, he told the AJC that, anecdotally, he and his colleagues are observing reduced hospitalization rates comparable to the findings in Eli Lilly’s phase 2 clinical trials.
Several doctors interviewed for this story said they are seeing similar results.
Dr. Kathy Hudson, chief medical officer at Phoebe Putney Memorial Hospital, said there are indications that even those who get the monoclonal treatment but end up later being hospitalized tend to be hospitalized for a shorter period of time compared with those who don’t get the treatment. Those treated also don’t usually progress to the point of needing to be in the intensive care unit, she said.
“We had the discussion, is it worth going through all of this?” she said. “But when you are talking about lives saved, can you really say it is not worth it?”
Jimmy Lewis, chief executive officer of HomeTown Health, an advocacy group for rural hospitals in Georgia, said some are offering the treatment and others are referring patients to other hospitals for it. He said doctors are impressed by a growing body of research and what they are seeing themselves.
“One doctor called it the miracle of miracles,” he said. “Patients who were heading to death’s door and 12 hours after the treatment, they are showing signs of being better.”
Razonable said one challenge is getting patients treatment before their condition worsens. The treatment is no longer effective once patients require oxygen supplementation, he said.
Hudson noted each patient must be evaluated before getting the infusion to make sure they still meet the criteria for treatment. Four patients who were scheduled for treatment were too sick and required hospitalization, she said.
‘Worst of it over’
Unlike some medications for patients hospitalized with COVID-19, supplies of the monoclonal antibodies treatment are ample so far.
The federal government purchased 950,000 doses from Eli Lilly and 300,000 doses from Regeneron, but only about 25% of the supply has been used according to the U.S. Department of Health and Human Services.
Jocelyn Moment, a hospice worker, and her husband, Alvin Moment, a mechanic, both of whom are diabetics, believe the Jan. 15 antibody treatment they had at Phoebe helped their recovery. She said she took her husband to the emergency room the day earlier when his blood sugar level soared to dangerous levels. She had a cough. He had muscle aches. They both had unrelenting headaches.
“The day after the treatment, we woke up and we were able to eat a little and just felt like the treatment was working,” she said. “It was very scary but we felt after the treatment, the worst of it was over.”
What are monoclonal antibodies?
The two treatments by Eli Lilly and Regeneron, are lab-made copies of the antibodies people produce naturally when they fight off infection. The treatment is believed to work by helping shut down the virus soon after infection.
Who can get the treatment?
The treatments are given to high-risk COVID-19 patients, which includes people who are at least 65 years old and those who have medical conditions such as diabetes, kidney disease or cancer. The treatment must be given within 10 days of first symptom, and the earlier the better.
How much do they cost?
The federal government is distributing antibody supplies at no cost to patients. However, some hospitals may bill insurance companies to administer the drug.
How do I get the treatment?
A doctor referral is needed. The U.S Department of Health and Human Services launched a web-based locator treatment (you can search for it on the HHS web site).
Eli Lilly recently announced its monoclonal antibody drug prevented COVID-19 illness in clinical trials, citing an 80% reduction in infections among resident at nursing homes who were exposed to the virus but got the drug, compared to those who got a placebo. The data has not been peer-reviewed or published. Eli Lilly will now consider approaching the FDA about extending the emergency use authorization to prevent the spread of COVID-19 in long-term care facilities. Then on Tuesday, Regeneron said its monoclonal antibody also prevented COVID-19 in a clinical trial involving the first 400 volunteers from the study.