With the nation on the verge of its biggest COVID-19 surge in November, a promising new treatment began trickling out to keep mild infections from turning deadly.
Maryland moved quickly to offer so-called monoclonal antibodies, the same thing used to treat then-President Donald Trump’s infection in October. And the state has been working since to promote and expand access to the lab-made immune system builder — the lone therapy for those who are not hospitalized.
Now, with cases again ticking up here and in many other states, possibly driven by variants, Maryland officials are trying to get the treatment to those most at risk for severe illness.
They have coordinated with health systems to open more than two dozen infusion centers around the state for at-risk patients referred by a doctor. The centers are largely at hospitals, including the Baltimore Convention Center field hospital. The treatment also is sometimes available in other settings, including emergency rooms and assisted living facilities.
“This is the first time we’ve had an outpatient treatment, and of course we grabbed it,” said Dr. Tara Saggar, assistant vice president of primary care operations for MedStar Health who helps oversee antibody infusions in the system’s hospitals.
There are now three forms of the antibodies from two drugmakers, Eli Lilly and Regeneron. Studies since last fall’s initial emergency-use authorization by the U.S. Food and Drug Administration have provided further proof of their effectiveness if given soon after virus symptoms arise. A Regeneron study recently showed the therapy reduced hospitalizations and deaths by 70%.
Some patients say they quickly began to feel better. Will Aldridge, a 44-year-old Bel Air business consultant, said he felt more energy within 24 hours.
Aldridge had developed mostly allergy-like symptoms after being exposed to an infected family member, and a rapid test at an urgent care center confirmed he had COVID-19.
He was referred for an infusion and was able to get an appointment at MedStar Harbor Hospital the next day. Speed is important; the antibodies must be used within 10 days of developing symptoms.
“I’d heard about it. President Trump had it when he had COVID and recovered quickly, but I didn’t know it had been approved for the public,” he said. “Why wouldn’t I do it? There was no downside.”
The antibody therapy is authorized for people outside hospitals, as it proved unhelpful for sicker patients. Those in the hospital with more severe cases have a few other options such as the antiviral medication remdesivir.
Doctors and public health officials say demand has lagged around the country for the antibody therapy, likely because of confusion or lack of information about it. They say the need for the treatment remains urgent because a lot of virus is circulating still and cases are rising again.
The PolicyLab in the Children’s Hospital of Philadelphia projects increasing cases over the next month in the Northeast corridor that includes the Baltimore region after steep drops since January. This is likely due to relaxation of pandemic restrictions, more lax masking and increasing prevalence of more contagious variants.
Dr. Howard Haft, an official with the Maryland Department of Health, said the state began putting resources toward the treatment immediately, moving staff to manage and monitor centers. Officials also have set up the state’s electronic medical record sharing system, known as CRISP, to allow doctors to document positive cases and refer patients to infusion centers.
The antibodies, like the vaccines, are supplied free to facilities by the federal government for specific groups that include seniors and those with underlying health conditions such as diabetes, obesity and immune system deficiencies. That means patients who are eligible for the treatment don’t have to pay for it. The Biden administration said it recently bought 100,000 doses for $210 million — $2,100 a dose — of the latest version of the treatment from Eli Lilly, which uses two monoclonal antibodies, and could buy up to 1.2 million more doses before the end of the year.
Haft said the state still is analyzing the data to see who is getting the antibodies and where, and how often they avoid hospitalizations. Data should be available in coming weeks.
So far more than 4,800 infusions have been given at 27 sites around Maryland. A recent tally showed the state still had about 60% of its doses available.
In addition to lack of information, there are various barriers to more widespread use, doctors say. That includes needing a doctor’s referral and the need to go to an infusion center.
The narrow window for use may be the biggest issue, said Dr. Arturo Casadevall, chair of the department of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health who has been studying antibodies.
“The earlier the better,” Casadevall said. “There is a big difference between Day 5 and Day 10. But so many people say, ‘I don’t feel good, but I’ll wait and see if I feel better.’”
Down the road, the biggest problem for monoclonal antibodies is they won’t necessarily work against all variants and will need to be retooled over months to match the circulating strains, Casadevall said. The FDA already stopped sending one of the antibody treatments to California and two other states because it wasn’t effective against a prominent variant there.
Maryland has reported variants in local cases, but none are currently seen as a dominant source of infections here.
Monoclonal antibodies trigger the body’s immune response when they bind to a protein from the virus and reduce the virus’ ability to infect cells. But Casadevall said they bind to the original strain of the coronavirus and become less effective as the virus mutates and eventually becomes distinct variants.
His research has helped inform two Hopkins studies of antibodies in blood plasma that could soon lead to a new and more flexible COVID-19 treatment. He said plasma wouldn’t need to be adapted for variants because it’s taken from people who are infected with whatever strain is circulating. Plasma also would be a cheaper alternative because it doesn’t have to be produced in a lab.
For now, officials will continue to push monoclonal antibodies in an effort to keep people out of hospitals.
MedStar has three centers around the state to help make visits more convenient. The hospitals had to shuffle spaces to accommodate the infusion centers, which need to be segregated from other operations, Saggar said.
She said the infusions go into the arm and take about 15 to 20 minutes. Patients must wait about an hour afterward to ensure there is not an adverse reaction.
So far, only about 6% to 7% of MedStar’s infusion patients have ended up admitted to the hospital, which she said is good because these patients are more at risk for severe COVID-19 due to underlying health conditions or age.
The U.S. Centers for Disease Control and Prevention found early on in the pandemic that about 9% of all people diagnosed with COVID-19 and no underlying health condition required hospitalization. But those who had an illness such as diabetes or lung or heart disease had a much higher hospitalization rate, about 40%.
One patient who ended up in the hospital after his monoclonal antibody infusion is Edward Kohlhepp, a 56-year-old Harford County man who believes he contracted COVID-19 on the job as a fire lieutenant.
He thought he had pneumonia, but after a trip to urgent care found out he had COVID-19 as well and was referred for an antibody infusion. Later in the day, he was still having trouble breathing and drove himself to MedStar Franklin Square Medical Center, where they began a course of remdesivir.
Kohlhepp said he felt significantly better the next day and was back to normal several days later except for an intermittent cough. He believes at least some credit goes to the antibody therapy.
“No one said,” Kohlhepp said, “but I think if it wasn’t for that I’d probably be in worse condition.”
At Meritus Health in Hagerstown, officials say they have had an even lower rate of hospitalization after the treatment: 4%.
Dr. Maulik Joshi, hospital president and CEO, called it “an incredible therapy.”
He said patients have been coming from around Western Maryland and beyond to the infusion center. It’s increased treatments to about 27 people a day from fewer than 10 a day when the facility became among the first in the state to open in November.
He said infusion centers will be needed for the foreseeable future.
“We focus so much on testing and vaccinating, this therapy can get lost,” Joshi said. “We need to continue to raise awareness.”