Arizonans avoid stays at hospital
Infusion of antibodies offers new treatment for fighting COVID-19
“We believe how (monoclonal antibody infusions) work is they help the immune system control the virus quickly. Instead of you having to make the antibodies, we’re just infusing them.”
Dr. Robert Orenstein
Chair of infectious diseases at the Mayo Clinic in Arizona
Her first symptoms — a scratchy throat and cough — were so mild that Jannie Cox “totally blew them off ” on Dec. 27, when they first emerged.
Three days later, the 74-year-old Tucson resident could no longer deny it: She was sick.
Her throat had become fiercely sore, she had flulike body aches, and it was clear she was either catching a cold, or worse. That same day, she tested positive for COVID-19 infection and her husband, 75-year-old David Syverson, was developing symptoms, too.
Cox, a retired health care foundation executive, knew what she wanted for herself and her husband: an intravenous infusion of a relatively new treatment therapy for outpatients with mild to moderate COVID-19 called monoclonal antibodies.
Early evidence shows it nips COVID-19 in the bud if caught in time, blocking the virus from replicating and turning into severe illness.
The treatment is becoming more widely available across Arizona and is one of several ways high risk COVID-19 patients are staying out of the hospital. Yet, more awareness is needed among members of the general public, health providers say.
Other programs to free up patient bed space during the pandemic that launched in recent months include a “COVID At Home” program operated by Phoenix-based Banner Health.
And in December, the Arizona Hospital and Healthcare Association began an at-home palliative care program with a $550,000 grant from the state health department, and $50,000 from Intel to help provide technology to patients who may not have their own.
The efforts are needed, even as hospitalizations statewide have begun to decline during the latest surge of the pandemic. Hospital leaders continue to be concerned about new variants of the coronavirus, including the more contagious U.K. variant, which they’ve said could lead to another surge of illness in March.
State data shows 3,456 patients with confirmed and suspected COVID-19 were hospitalized in Arizona hospitals as of Feb. 2. It’s lower than the peak on Jan. 11, when the number of hospitalized patients reached 5,082, but for the entire month of
January, COVID-19 hospitalizations in Arizona remained at a higher level than the July summer peak.
‘We’re just infusing them’
Two monoclonal antibody therapies were approved for emergency use authorization to treat mild to moderate new coronavirus disease in certain high-risk patients by the U.S. Food and Drug Administration in November — bamlanivimab from Eli Lilly and Co. and Regeneron, which combines the two monoclonal antibodies casirivimab and imdevimab.
Regeneron became more widely known when it was used to treat former President Donald Trump after he tested positive for COVID-19.
Both monoclonal antibody therapies have shown promise for clearing the SARS-CoV-2 virus that causes COVID-19 and reducing illness when patients receive the medication within days of their first symptoms. It is a treatment for COVID-19, not preventive, health providers stress, citing some confusion among members of the public. Monoclonal antibodies are not the same as the COVID-19 vaccine rolling out right now.
For health leaders in Arizona, infusions of monoclonal antibodies are not just a way of impeding the progression of illness in patients with COVID-19, they are a way of keeping patients out of hospital beds at a time when resources are stretched.
The federal government recently set up a monoclonal antibody infusion center at Tucson Medical Center, and Banner Health has established centers in Tucson and Phoenix.
The Mayo Clinic in Arizona first opened its monoclonal antibody infusion center on Dec. 7 in a mobile unit at its Phoenix campus treating eight patients per day, and last week moved the program to expanded space with the ability to treat more patients in an area on its Scottsdale campus that had previously been used for furniture storage. The new space allows for 30 to 50 patients per day to get infusions.
Cigna Medical Group partnered with the state, the FDA and Operation Warp Speed to launch the pilot program to provide the monoclonal antibody infusion therapy for high-risk COVID-19 patients referred by a health provider at its four urgent care facilities around the Valley.
The pilot has started at CMG’s Phoenix Central and Paseo Urgent Care sites and has initial capacity to provide two infusions a day at each location “to help free-up much needed hospital space and resources,” officials said.
More data on outcomes is needed but some early research shows the monoclonal antibodies are effective at preventing hospitalizations. The idea is that they bind to the receptors of the spiked protein of the virus and block it from reproducing.
“As the number of admissions started going up, we were trying to find some way to decrease the pressure on our hospital,” Dr. Robert Orenstein, chair of infectious diseases at the Mayo Clinic in Arizona, said of his hospital’s decision to begin monoclonal antibody infusions.
“We believe how they work is they help the immune system control the virus quickly. Instead of you having to make the antibodies, we’re just infusing them,” he said.
Mayo officials are in ongoing discussions about how to get monoclonal antibodies to more Arizonans.
“Obviously, the number of people that could benefit is far more than what we’re able to even do,” Orenstein said. “The problem is the logistics of it, and getting the information to the people, and being able to ensure that the right people get it . ... We’re looking at ways to try to expand and be of some value to the community beyond what we are currently doing.”
‘He’s doing fantastic today. It’s all behind us’
For about two to three hours on New Year’s Day, Cox and her husband each were infused with monoclonal antibodies at an infusion center set up by the federal government in partnership with Tucson Medical Center.
Cox’s COVID-19 symptoms went away the day after her infusion, she said. Her husband, who has Parkinson’s disease and rheumatoid arthritis, had more challenges and at one point was having stroke-like symptoms that ended up being related to his Parkinson’s.
But he was never hospitalized for COVID-19, and Cox says he’s doing well.
She can’t know for certain but believes the monoclonal antibodies saved her husband’s life.
“He’s not just recovered, he’s better than before,” she said. “It was very, very rough for two weeks, but he’s doing fantastic today. It’s all behind us.”
Cox, who is an avid cyclist and walker, has no way of knowing how the monoclonal antibodies changed the trajectory of her disease, either. Nonethe
“He’s not just recovered, he’s better than before. It was very, very rough for two weeks, but he’s doing fantastic today. It’s all behind us.”
Jannie Cox
Tucson resident talks about how monoclonal antibody infusions helped her husband as well as herself
less, she said she feels blessed that the couple was able to get the infusions. Cox felt better the day after receiving the infusion and said she is 100% now.
“It is impossible to know,” she said. Not everyone is eligible for the monoclonal antibodies, and various infusion centers have their own parameters about eligible patients.
TMC officials are using both the Regeneron and Eli Lilly products to treat adults and pediatric patients, 12 years of age and older who weigh at least 88 pounds, who have positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
High-risk adults must meet at least one of a list of criteria to be eligible for the TMC infusion center, including having a body mass index of 35 or greater; having chronic kidney disease, diabetes or immunosuppressive disease; undergoing immunosuppressive treatment; or is 65 or older.
Infusion centers do not accept walk-ins
The infusion itself takes about an hour, but Cox said medical providers spent a lot of time with her beforehand, going over the risks. Also, patients must remain for about an hour following the infusion to ensure patients are not having any reactions. Altogether the process from beginning to end is about three hours.
Since it opened in January, the TMC center has infused 600 patients. None has had allergic reactions to the medication and anecdotally, about 1% have been admitted to the hospital, though actual outcome data is not yet available, said Mimi Coomler, the hospital’s chief operating officer.
The highest number of patients TMC has infused with monoclonal antibodies is 57 in one day. The average is about 24 per day, Coomler said.
The hospital has been infusing patients in a space with a separate entrance in its hospital but will be moving to a center at another hospital-owned property. A federal team that had been staffing the center was scheduled to leave in early February, but Coomler said TMC officials have decided to sustain the program because of its success.
Patients must meet the criteria to get infusions. They also must have symptoms and a positive test. The hospital’s urgent care network has been a key referral source, which is also true for Banner Health’s infusion centers. TMC’s Coomler emphasized that patients who get referrals can be infused quickly.
“We absolutely have availabilities same day, next day, because the criteria includes up to 10 days from diagnosis, there is a time sensitivity. We don’t want patients to time out,” she said.
Banner Health has a capacity for seeing 75 patients per day statewide at monoclonal antibody infusion centers located at Banner University Medical Center Phoenix, Banner Baywood Medical Center and Banner University Medical Center South in Tucson. All three locations are open seven days per week, said Dr. Jason Brown, chief medical officer for Banner Pharmacy Services.
It’s important that patients do not show up at the infusion centers without an appointment, Brown emphasized. Firstly, there are criteria about who is allowed to get the infusions. Secondly, there are logistics and rules about having contagious COVID-19 patients in the facilities, which is why patients need to have appointments.
Banner Health’s urgent care centers are handling referrals to the infusion centers for now, and patients may also talk to their doctor about getting a referral, Brown said.
Banner Health is using both the Eli Lilly and Regeneron products. The health system’s pharmacy and therapeutics committee did their own clinical efficacy and safety reviews and does not feel that one product is superior to the other, Brown said.
‘The earlier the better. That is the biggest challenge’
Banner Health has an information page about monoclonal antibody treatment on its website, and Brown stressed the therapy is for people who are not already hospitalized. It’s for newly symptomatic people who are at high risk of progressing to more severe COVID-19 and winding up in the hospital.
To be eligible at a Banner site, patients must test positive for COVID-19 and be less than 10 days from onset of symptoms, plus meet one of a set of criteria: be over 65 years old; be over 55 years old with comorbidities such as cardiovascular disease, high blood pressure or COPD/other chronic respiratory disease; or over 18 years old with comorbidities such as diabetes, immunosuppressive disease, chronic kidney disease or obesity.
Because of limited space and staffing in its infusion center, the Mayo Clinic in Arizona has been selecting patients for monoclonal antibodies based on a nightly review of the electronic medical records of those who tested positive for COVID-19 at their clinics, and choosing patients for the available infusions each day using a ranking system based on risk. Among those on the review panel were infectious disease physicians, a nurse, and an ethicist.
“If you are immunocompromised you are obviously at a higher risk than somebody who is 65 but doesn’t have any other risk factors,” Orenstein said. “We had a scoring system that helped to stratify risk. And we only give it to people who are symptomatic.”
Now that the Mayo Clinic has a larger infusion space, they are hoping to get a larger supply of medication and open up the monoclonal antibodies to anyone who meets the criteria set out in federal emergency use authorization for the therapies, including being 65 and older or having certain chronic health conditions, Orenstein said.
Although the emergency use authorization says the monoclonal antibodies should be given within 10 days of the onset of symptoms, Mayo officials have been saying seven days.
“The earlier the better,” Orenstein said. “That’s really the biggest challenge. Most people really don’t feel all that bad until they get to about day six or seven and they are getting close to the point where it is already too late to get benefit from the antibodies.”
COVID at Home: Patients up to age 70
In addition to monoclonal antibody treatments, Banner Health recently created a COVID at Home telehealth program, which allows shorter hospital stays for some new coronavirus patients between the ages of 18 and 70 who are hospitalized with COVID-19 but have not been in the intensive care unit.
The program is available at acute care Banner Health facilities that are caring for COVID-19 patients, including small rural hospitals. Nearly all the patients in the program so far have been in Arizona.
COVID at Home began in August after a lot of discussion with clinicians from various areas of the health system about the best way to free up hospital beds, said Dr. Michael Simons, medical director for telehealth at Banner Health. They decided to target COVID-19 patients who were already hospitalized at the end of their hospital stay and work on getting them home earlier than normal protocol would allow.
“We knew that every patient we got out one day early was an extra hospital day worth of capacity that we would open up,” he said. “When we initially rolled out this program we developed a long list of inclusion and exclusion criteria, which were really meant to make sure that we had a pretty clean denominator of low risk patients and that they were reasonably well-controlled to be appropriately sent home.”
Patients in the program are sent home with a pulse oximeter that they must use four times per day and at scripted intervals they must record both their heart rate and the oxygen levels in their blood into a software program that’s downloaded on the patient’s smart device, Simons explained. Before the patient leaves the hospital, medical staff make sure the software has been properly installed.
A group of nurses monitors the patients’ entries, troubleshoots, and reaches out when there are issues such as a low oxygen saturation or high heart rate. Part of the technology includes the ability to do daily virtual visits with a physician.
“Our intent in trying to craft this program was to replicate as much of the hospital stay as we thought we could and was necessary for these patients that we were sending out one to two days earlier than they would otherwise go home,” Simons said.
At the end of each day, patients must fill out a checklist asking about common symptoms such as nausea, vomiting or pain that could indicate a blood clot. Patients may call a centralized number if they do have any of those symptoms and a medical provider will help them
with how to proceed.
The program is still relatively small. Thirty-one patients have gone through it. Now two to three are getting added per day, Simons said.
What program leaders did not want was to send people home and have them decompensate and need to be readmitted because they were sent home too early. So far, that hasn’t happened. As of Jan. 12, no one from the program had been readmitted to the hospital.
“We are now tending to get patients out at least one day early and in some cases, two days early and that was our initial target,” he said. “We wanted to be very cautious that we weren’t impugning their safety by sending them home and we were really trying to limit this to the patients that can be safely discharged and monitored commensurate with their needs.”
COVID-19 palliative care program could be helping more patients
The Arizona Hospital and Healthcare Association’s recently launched palliative care is a another way of preventing COVID-19 patients from being admitted to the hospital by supporting them at home with telehealth, and helping them coordinate their care.
The program is also for preventing COVID-19 patients who have been hospitalized from being readmitted, and targets people in underserved communities, organizers said.
Palliative care is often confused with hospice, but it’s not the same thing. People who need palliative care need support and help coordinating their health care, and making a plan for their care, whether they are acutely ill or chronically ill.
Sometimes it is end-of-life care, but most of the time it’s not, said Sandy Severson, senior vice president of care improvement at the Arizona Hospital and Healthcare Association, who spearheaded the COVID-19 palliative program.
The program finds patients solely by referral from a physician, nurse practitioner, long term care facility or other health provider. Instead of sending patients to a hospital, the program seeks to treat people where they are. The program went live Dec. 18 and so far is being used mainly by rural Arizonans, Severson said.
“A typical patient is someone who is just experiencing COVID now and is having shortness of breath and has been in to see their primary care doc repeatedly but they need supportive care, that extra layer of care . ... People want to be at home. They don’t want to go to the hospital.”
The program sets goals of care, establishes the resources the patient needs moving forward, and part of the protocol is including family members, Severson explained.
“Some of these might be young people, some might be aging people and not have a lot of resources,” Severson said of the patients. “We really talk about what their goals are and whether they need medication management changes or just emotional support, clergy, faith-based support, to make sure everyone knows what the plan is.”
Another part of the program is helping patients plan for future care, whether that means ensuring they have a health care power of attorney lined up, or that they state their wishes about going on a ventilator or being resuscitated if they stop breathing or their heart stops beating.
If someone has already said they don’t want to be on a ventilator, or don’t want to be resuscitated, the support that patient needs typically would not require an acute care hospital, Severson said.
In other words, there’s no point sending a patient to a hospital if there’s nothing the hospital can do for them. That’s where the palliative care program can help, by ensuring those patients safely get the support they need at their long-term care facility, or wherever they are living, rather than going to the hospital.
Severson is hoping to spread the word about the palliative care option. The program has four providers on contract who can consult with 30 to 40 patients per day but is not anywhere near that capacity now, Severson said.
Some of the patients who are in the program have been hospitalized for COVID-19 and are coping with the aftermath of health effects, including heart and lung issues. Several have the anxiety of not knowing whether they will recover, Severson said.
“These are people many times who are on oxygen who have complex issues but the intent is to keep them at home and not go back to the hospital,” Severson said.