Mayo launches therapy to prevent COVID-19 hospitalizations

Jay Clark thought he was suffering from nothing more than sinus and chest congestion. But just to be sure, he took a COVID-19 test.

So when the result came back positive, Clark couldn't believe it. Four days later, the 67-year-old Rochester resident became one of the first COVID-19 patients in Minnesota to receive a new treatment that could prevent those with the virus from being hospitalized.

"I notice a little tightness in my chest," Clark said the night before receiving the infused medication at Mayo Clinic last week. "I'm not short of air, but I don't think I want to go run a marathon right now."

Mayo hustled this month to create dedicated space within a medical building in Rochester to administer the therapy, which federal regulators approved Nov. 9 for emergency use. But the drug is in short supply and brings logistical challenges that other health care providers still are trying to work through.

Similar to a drug given this fall to President Donald Trump, the treatment is not intended for use in all COVID-19 patients, nor can it prevent infection, said Dr. Andrew Badley, chairman of the COVID Research Task Force at the Rochester-based clinic. So, slowing the spread of the coronavirus remains key.

"Now and for the foreseeable future, it is critical that all of society maintains social distancing, frequent hand-washing, avoidance of large gatherings and universal masking," Badley said.

Health systems are stretched thin by the surge of COVID-19 patients and the loss of workers sidelined after being exposed to the virus. Even so, they hope in the next week or so to get programs running for the treatment, according to the Minnesota Department of Health.

Providing the care requires strategies to safely administer it while maximizing the scarce supply, said Dr. Andrew Olson, medical director for COVID-19 Hospital Medicine at M Health Fairview. Doctors want to make sure patients who benefit most get the treatment, he said, but they don't want the access to reinforce disparities between patients in different racial, ethnic and socioeconomic groups.

"I have deep empathy for the people who saw this and said: I want this medication right now," Olson said. "Adding capacity like this is challenging. We will rise to that challenge, but it's hard."

In October, the federal government announced the purchase of 300,000 doses of bamlanivimab, a therapy meant for patients with mild COVID-19 who haven't been hospitalized and don't require oxygen therapy. It's authorized for those 65 and older, or with certain health conditions, who are at high risk for progressing to severe COVID-19 and/or needing hospitalization.

Manufactured by Indiana-based Eli Lilly, the treatment consists of laboratory-made antibodies that are infused in patients and designed to block the pandemic virus from attaching to and entering human cells.

Ethical guidelines

To be effective, the drug must be administered within 10 days of symptom onset. Demand is expected to far exceed supply, at least initially, so the state Health Department has issued ethical guidance on administering the treatment, such as whether to give it to terminally ill patients with life expectancy under six months.

Because the treatment is time-sensitive, the guidance says health care facilities providing it should do so seven days per week. If demand at a facility is three times the supply, providers should consider randomly assigning the treatment to one-third of patients, the state guidance says.

If that's not possible, then "first come, first served is adequate for the time being," according to the guidance document. It notes, however, that such an approach "often puts certain populations at a disadvantage, including the uninsured [and] those without a primary care provider."

The federal government expects to distribute doses in weekly shipments through year's end. Minnesota was allocated 2,400 doses the first week of the program and 1,400 doses for the second week; they're being distributed on a regional basis.

The state Health Department planned on distributing 2,762 doses of the medication by last Friday, including treatments that Mayo Clinic started administering last week.

Mayo has a large infusion center in Rochester, but Clark last week was directed to a different center recently created for COVID-19 patients. Many patients who need infusion therapies have cancers and other conditions that put them at high risk for serious illness with COVID-19, so doctors are very focused on separating them from patients with active coronavirus infections.

"Our usual infusion center is a mile away," said Dr. Raymund Razonable, an infectious disease expert at Mayo who supervised Clark's treatment. "This one is just on its own."

Study results suggest the treatment can cut by two days the time it takes for symptoms to resolve, Razonable said, and can reduce the risk of hospitalization from 10 to 3%.

'First guinea pig'

Upon arrival, Clark was instructed not to touch anything on his way to the treatment area. He declined a ride in a wheelchair, but clinic workers held open doors as he walked to a room with a reclining chair and IV machine.

Health care workers hooked the IV to a vessel on top of Clark's right hand. The refrigerated solution was cold as it entered his body.

"You feel the cold on your hand and you feel it starting going up your arm," he said. "It gets about halfway between your wrist and your elbow."

After spending an hour receiving the treatment, Clark was monitored for another hour to make sure there were no side effects. He said there were no problems the next day, either.

"The COVID just drains your energy," Clark said, adding that he's sleeping much longer at night because of the virus. He's pretty sure he caught it during "happy hours" at a neighborhood tavern, since several of his friends who attended also tested positive.

Of the treatment at Mayo, Clark said: "I'm all for being the first guinea pig, let me tell you. … I don't know how I got to be No. 1."

While Clark was the first patient treated in Rochester, Mayo first administered the medication last week to patients at another location in southern Minnesota. The clinic now is in the process of launching other sites across the region.

It's going well, clinic officials say, although they've been surprised to learn some patients are reluctant — either about how the treatment will interact with other medications, or because they think they're not yet sick enough.

"The treatment is not metabolized in the usual manner, by the kidneys or liver, and thus, is not expected to interfere with other medications," the clinic said Friday in a statement. "The criteria for patients to be offered this treatment is that they have a serious chronic/underlying condition that is much more likely to result in severe COVID symptoms and even hospitalizations, even if they are 'holding their own' so far."