Duluth's two health care systems, Essentia Health and St. Luke's, are now weeks into offering monoclonal antibodies as a COVID-19 treatment for people with mild to moderate symptoms and at high risk of becoming hospitalized.
The U.S. Food and Drug Administration issued an emergency use authorization of the treatment in November. Shortly after, the federal government began distributing the treatment to states.
Those eligible for a monoclonal antibody infusion include people within the first 10 days of symptom onset who are at least 65 years old along with people under 65 who have comorbidities like diabetes, heart disease and asthma, said Dr. Jonathan Shultz, emergency medicine physician at St. Luke's.
"Patients who are diagnosed with COVID-19 and think they might benefit from this treatment, they should contact their primary care doctor as soon as they're diagnosed to discuss it," Shultz said. "Their doctor would be able to refer them to our clinic if they felt that was appropriate."
Monoclonal antibodies are made in a laboratory and act like natural antibodies in that they limit the amount of virus in a person's body.
"This is doing the same thing that your immune system would do to fight off the virus," Shultz said. "It's just that your immune system takes a number of days to develop its own antibodies. So we're infusing these antibodies directly, so that it immediately fights COVID."
The treatment is to prevent progression of the disease and its symptoms, while keeping people out of the hospital. Because of that, people diagnosed with COVID-19 can only receive the therapy within the first 10 days of symptom onset.
"From the day of their symptom onset, the clock starts ticking," said Dr. Amanda Noska, infectious disease physician at Essentia Health in Duluth. "COVID goes in waves. Some people only have one wave, but some people have more than one wave of illness. And we want to catch them on the first wave. The first wave is 10 days long."
While it's not yet known if the treatment helps to prevent death from COVID-19, an ongoing clinical trial called the BLAZE trial showed the risk of hospitalization decreased 7% and that people improved quicker. People in the trial who didn't receive the treatment until they were very ill did worse.
Noska said the point at which the treatment needs to be administered — while people are still feeling relatively OK — is often counterintuitive to patients.
"COVID is a little sly. It can sneak up on people and it can take literally weeks to do that," Noska said. "When they would be most liable to benefit from it, they don't feel sick enough to want it."
Not everyone eligible to receive the treatment has elected to do so, physicians from both hospitals said. It's one of the reasons, Shultz said, that the demand for the treatment isn't as high as health officials anticipated.
In fact, the opposite has been the case. Nationwide facilities have underutilized their allocations of the treatment.
Around Christmas, St. Luke’s opened an antibody infusion clinic on its Duluth campus. Since each patient spends about two hours there, providers can only see a limited number of people each day. St. Luke’s can see about 10 patients each day.
Neither health care system has had more patients electing to receive the treatment than they could accommodate. As of Friday, Essentia Health had given 227 patients the therapy systemwide.
In the instance that demand outweighs supply of the drug, health care providers have to follow guidance from the state of Minnesota requiring them to use a randomization process to ensure that the supply is distributed fairly and equitably.
Essentia also has designated spaces where COVID-19 patients can receive the infusion therapy across the system, including at the St. Mary’s Medical Center campus in Duluth. The system also anticipates a clinic will go live at its Virginia campus soon, possibly even in Deer River, too, said Stephanie Nixon, antimicrobial stewardship manager at Essentia.
“We have tried very hard not to bring patients into our existing outpatient infusion centers because we deal with a lot of cancer and oncology patients, and patients who are already immune compromised,” Nixon said.
To Nixon's knowledge, Essentia has not yet had to turn anyone away.
"We have literally turned our staffing and our processes upside down to accommodate patients who we learned had a different onset of symptoms date, or their eligibility window narrowed for reasons that we couldn't have anticipated," Nixon said. "We have pulled staff in. We have set up new appointment schedules. We have done everything that we can to get patients in."
Dr. Elisabeth Bilden is one of the physicians who works in Essentia’s new antibody infusion clinic for COVID-19 patients. As a toxicology physician with a background in emergency medicine, it’s outside her normal realm of work.
“Part of the reason I signed on to help was the relief when I heard that we have a way to help and contact patients at home,” Bilden said. “It's more reassuring that we're hopefully going to catch those patients who do get ill and try to identify that early on and bring them in if they need to.”
To learn more about who qualifies to receive the monoclonal antibodies, find the Minnesota Department of Health's webpage on the treatment at health.state.mn.us/diseases/coronavirus/hcp/bamfaq.