Test positive for COVID-19 and at high risk? Monoclonal antibodies offer hope
Lindy WashburnIt’s a nightmare. You develop a fever, lose your sense of taste and smell, and then test positive for COVID-19. You worry you may become short of breath, suffer alone in a hospital room, require a ventilator to breathe. You know there is no cure.
Since November, however, hospitals have offered hope to those at high risk of severe illness from COVID-19. It’s an infusion of monoclonal antibodies — an experimental treatment that has kept more than 95% of those who received it out of the hospital.
During a still out-of-control pandemic, that helps to save health care resources such as hospital beds, oxygen and personal protective gear.
The infusion, when given early in COVID-19, appears to “cut it off right at the knees,” said Indu Lew, the chief pharmacy officer for RWJBarnabas Health in New Jersey, which has used the treatment on more than 2,000 eligible patients since Nov. 19. It’s the same treatment that former President Donald Trump received.
“I feel like it’s miraculous,” said Josephine Darcy, a 66-year-old retiree from Belle Mead, New Jersey, whose infusion was given in RWJ University Hospital Somerset's emergency room on Jan. 13. “When I tested positive, I was terrified.”
Her husband had already been diagnosed, and a doctor had phoned with her positive test results and recommended the treatment. Darcy received it just four days after she woke up with a fever, chills, and a headache — and without her sense of smell and taste.
A week later, in an interview from her home, she said her sensory loss persisted, but her symptoms had devolved into a head cold and a little achiness.
“She got the same treatment the president of the United States got, without being helicoptered to Walter Reed [National Military Medical Center],” said Dr. Douglas Ashinsky, an internal medicine physician with RWJBarnabas Health Medical Group who conducted follow-up visits with Darcy via telemedicine. “She was able to stay with her family and get better at home.”
More than 3,100 New Jersey patients have received such infusions. Two-thirds of them were treated at RWJBarnabas Health hospitals. Another 430 have been treated at Holy Name Medical Center in Teaneck, New Jersey, through research studies and a federal pilot program for underserved communities.
For these patients — obese, diabetic, on dialysis, or merely over age 65, like Darcy — an hour with an intravenous line pumping medicine into a vein in the crook of their arm appears to halt the progression of COVID-19.
It also has kept all but 3% of those who received it in New Jersey — and all but 4% nationally — out of the hospital, according to the state Health Department.
The trick is the timing.
The infusion must be given within 10 days after the initial symptoms of COVID-19 appear, and preferably much sooner.
“The best response is in the range of three to five days after onset of symptoms,” said Dr. Thomas Birch, an infectious disease specialist at Holy Name.
He estimates that 10% to 15% of the more than 5,000 people who have been reporting positive test results each day in New Jersey lately would have been eligible to receive treatment with monoclonal antibodies — at least 500 to 750 potential patients a day.
And now that hospitals have worked out safe and efficient procedures for infusing these infected patients and have enough supplies, they want to make sure potential patients and their doctors know it’s an option — and to ask for it.
Lab-grown proteins block the virus
Monoclonal antibodies are infection-fighting proteins manufactured in a laboratory using genetic information from the cells of survivors of COVID-19, grown in genetically engineered mice.
The antibodies have been designed to thwart the invading coronavirus by binding to the spike proteins on its surface, so it cannot use them to penetrate the cells and replicate. By reducing the viral load — or amount of infectious material circulating in the blood — it is thought this slows or limits the course of the disease.
Trump received the infusion at the White House on Oct. 2. Former Gov. Chris Christie received a similar treatment after he checked himself into Morristown Medical Center later that month. Rudolph Giuliani, the president’s personal lawyer, and former Housing and Urban Development Secretary Ben Carson also were treated with monoclonal antibodies before they had been authorized for broader use.
In November, the federal Food and Drug Administration granted emergency use authorization to two companies that developed the treatment, Eli Lilly and Regeneron. It was the first authorized treatment intended to keep people with COVID-19 out of the hospital.
Lilly uses a single antibody and Regeneron, a Tarrytown, New York, company, combines two antibodies in a “cocktail.”
“These are sick people — on dialysis, with renal transplants, diabetics,” and other conditions that would make them especially vulnerable to complications from COVID-19, said Dr. Christopher Freer, senior vice president in charge of the emergency departments at RWJBarnabas Health’s 11 hospitals.
Of nearly 2,100 patients treated with monoclonal antibodies at his hospitals, he said, “over 95% of them did not need to come back for a COVID hospitalization.”
As he spoke, Freer received a text from a primary care physician asking if his patient — a man in his 30s, 6-foot-2 and weighing 305 pounds — was eligible for the one-hour, outpatient infusion. With a body mass index classified as obese, he was.
Holy Name reported similar results: Fewer than 5% required hospitalization for COVID-19 after the treatment. That’s a fraction of the 14% whom Birch estimated would have been hospitalized without it.
Simple eligibility criteria
The criteria for treatment with monoclonal antibodies, set out in the FDA’s emergency use authorization, are clear-cut and easy to use.
A patient must have tested positive on a PCR test within the previous 10 days, have symptoms of COVID-19 that aren't bad enough to need oxygen, and be at least 12 years old. In addition, they must be at higher risk of severe illness or hospitalization for COVID-19 because they are:
- 65 years old or older
- 55 years old or older with heart disease, high blood pressure, or chronic respiratory disease, including asthma
- Any age with obesity, diabetes, chronic kidney disease or a weakened immune system, or requiring medication that suppresses the immune system.
“I’m very excited to have this to offer, after having lived through March and April,” said Freer, an emergency physician, of the first wave of the pandemic that washed over New Jersey hospitals.
“You’re giving a patient a better chance to have a better outcome," he said. "And our biggest fear is we’re not going to have enough beds for the people who need them.”
One patient's experience
For Josephine Darcy, the hardest thing was coming to a quick decision about whether to get the treatment. She knew that if she declined and waited, her condition might quickly deteriorate. After a call to her primary care doctor, she agreed to the treatment, and the doctor made the arrangements. Currently, patients cannot refer themselves.
“I simply walked into the emergency room and told them why I was there,” Darcy said. “It took about three hours.”
After the infusion, she watched television for an hour in the room while she was monitored for an allergic reaction. Fewer than 1% of patients have had an allergic reaction, which is easily treated, Freer said.
Then Darcy drove herself home.
“I felt fluish, and took some Advil,” she said. “That was it, other than a head cold came on.”
The hospital gives patients a pulse oximeter, a device to measure the level of oxygen in their blood, when they are discharged. Then a doctor follows up with two telemedicine visits.
“The person will tell you instantaneously when you speak to them, ‘I feel good. The fever is gone,’” said Ashinsky, who has checked in with about 500 post-transfusion patients. If their pulse oximeter reading drops below a certain level, he tells them to call him; they may need to go to the emergency room.
But that happens infrequently.
“We’ve come a long way in a short time,” said Holy Name’s Birch of medical advances that have made this treatment possible. “We have a really good quality therapy. We want people to be referred by their doctors.
“Then we will get them in as soon as possible, because time is of the essence.”
Through Operation Warp Speed, the federal government has agreed to purchase nearly 2 million doses of monoclonal antibody treatment. They are distributed to the state’s hospitals free of charge, though individual hospitals may charge “administration fees.”
Lindy Washburn is a senior health care reporter for NorthJersey.com. To keep up-to-date about how changes in the medical world affect the health of you and your family, please subscribe or activate your digital account today.
Email: washburn@northjersey.com
Twitter: @lindywa