Clinical treatments for COVID-19 have been elusive since the start of the pandemic and for nine months there were few medical options to help newly infected patients from spiraling into respiratory failure, immune system overload and other potentially fatal situations.
But doctors at hospitals in New Jersey, and nationwide, are now embracing a drug therapy that is helping to keep some of the most at-risk patients from getting sick enough to be hospitalized or die of COVID-19. New research shows this treatment — which binds proteins called monoclonal antibodies to the coronavirus in ways that prevent the virus from entering human cells, where it reproduces — is largely effective when given soon after people develop initial symptoms.
“There are not many silver linings (with COVID-19) as an emergency doctor. This is a silver lining,” Dr. Chris Freer, a senior vice president with RWJBarnabas Health, said of the treatments, the first of which were granted emergency use authorization by the federal government in November.
“We had no (COVID) weapons until (this) in the emergency department,” said Freer, who oversees emergency-room operations at the system’s 11 hospitals, all of which have adopted the monoclonal antibody protocol. “It clicked and we just ran with it and now every one of our sites has a plan, has a process” for the treatment, he said.
Since early November, RWJBarnabas Health hospitals have treated nearly 6,200 individuals on an outpatient basis using monoclonal antibodies, Freer said, possibly more than any other single hospital system nationwide. Of these individuals, 96% avoided hospitalization and only one had died as of March, he said.
Vaccines plus treatments
“We’re seeing success with it,” Freer said. While vaccines will continue to drive down the number of COVID-19 cases, the virus will be with us for some time, he said, underscoring the need for treatments like monoclonal antibodies. “We’re not going to be done with (this disease immediately.) I think it will have a place in the future,” he added.
When the pandemic began in March 2020, emergency rooms in New Jersey were flooded with infected individuals, some with surprisingly low levels of blood oxygen. Those struggling to breathe were admitted and, by April, two-thirds of these patients — an unusually high percentage compared to non-pandemic times — were in intensive care, with many on ventilators, according to data from the New Jersey Hospital Association. Over the past year, hospitals here have treated more than 66,000 people who subsequently were discharged.
In April 2020, more than one in four COVID-19 patients admitted to New Jersey hospitals did not survive, NJHA found. Pharmaceutical interventions for those hospitalized remain limited — federal guidelines recommend just two drugs, the anti-viral remdesivir and dexamethasone, a steroid — but clinicians have found success in changing how patients get oxygen support, shifting from ventilator use to other, less invasive options. This evolution, along with other changes in clinical and operational protocols, has helped shift the survival rate from less than 74% to nearly 86% at hospitals here, NJHA notes.
“As one of the nation’s first COVID-19 hot spots, New Jersey hospitals and their clinical teams played a key role in advancing the knowledge surrounding these emerging treatments,” said Sandy Cayo, an advanced-practice nurse who is vice president of clinical performance and transformation at NJHA. “That work contributed to improved outcomes for COVID patients in New Jersey.”
But during the pandemic’s initial wave, hospitals also struggled to assist the thousands of patients who came to the ER with mild to moderate COVID-19 symptoms — coughing, weakness, lack of taste or smell — that did not require them to be admitted, especially given the shortage of beds. In New Jersey and nationwide, patients like this were essentially told to go home, ride it out with the help of over-the-counter medications, and come back if they felt worse, Freer and others recalled.
Availability of monoclonal antibodies
Monoclonal antibodies changed that practice. “What we saw in March and April 2020 was that we would appropriately discharge people that came back three or four days later,” Freer said. Many of these individuals met the criteria for the monoclonal antibody treatment now available, he said, in that they were over age 65 or had risk factors like COPD (chronic obstructive pulmonary disease), diabetes or renal disease. “All those things fit right into what we learned from March of 2020 and now we fast forward and we’re giving emergency providers an offensive weapon to attack and potentially give the patients a better outcome.”
According to the New Jersey Hospital Association, monoclonal antibody treatment is now available at some 60 of New Jersey’s 72-acute care hospitals, including smaller systems like Virtua Health in the south and the massive Hackensack Meridian Health, which stretches from Bergen to Ocean counties.
Monoclonal antibody therapies have been developed for other diseases, including Ebola. The treatment depends on lab-created proteins that mimic aspects of the human immune system, according to Dr. Gregory Breen, a pulmonary specialist with Inspira Health, which has treated some 255 COVID-19 patients with monoclonal antibodies. These proteins have a unique ability to bind to the spikes on the exterior of the coronavirus in a way that prevents it from getting inside human cells to replicate, he said.
“This is a preventative treatment, trying to catch the patient before the disease gets uncontrolled,” Breen said. “If we get them early, before all the symptoms develop, that’s where you have the biggest bang for the buck.”
Without treatment, Breen said that up to 15% of these patients would likely be hospitalized at some point in their disease. With the monoclonal antibody treatment, he said Inspira has lowered the hospitalization rate to almost 5%. “Our experience has been wonderful,” Breen said.
The treatment itself involves an hour-long intravenous infusion with a two-drug cocktail, plus an hour or more of observation to monitor for any reactions, clinicians said. There is no additional out-of-pocket cost to patients. The current federal authorization limits use of the protocol to those of an age or health status that put them more at risk for severe illness; the person must have only mild to moderate COVID-19 symptoms and the treatment must be administered within 10 days of those symptoms emerging.
“If you’re sick enough to be admitted (to the hospital) this is not a treatment for you. It could possibly make you worse,” Freer of RWJ Barnabas Health said.
The Federal Drug Administration recently revised its emergency authorization to require that one of the drugs created for this purpose only be used in conjunction with another — not just alone, as it was initially — since the combination is far more effective, according to NJHA’s Cayo. “That’s the evolving nature of confronting a novel virus; clinicians are constantly seeking to improve care, and researchers are continuously monitoring the results and the science so that we can move forward with evidence-based treatments,“ she said in an email.
Do enough people know about it?
Despite the promising outcomes, health care leaders worry that not enough people know the treatment is available, or that people will wait too long — hoping the illness goes away on its own — before seeking help. People who experience early symptoms of COVID-19 infection should promptly contact their doctor to see if they qualify for monoclonal antibodies, they said.
COVID-19 “is explosive like nothing I’ve ever seen in my 20-plus year career. It is a devilish disease,” Breen said, underscoring the need to act quickly.
That concern has prompted state health officials, including Department of Health commissioner Judy Persichilli and former state epidemiologist Dr. Eddy Bresnitz, who is advising the state’s COVID-19 response, to highlight the potential of monoclonal antibodies at times during the administration’s regular pandemic briefings. The health department has also promoted the option on Twitter and posted guidance on its website for health care providers and patients.
“There is more and more evidence accumulating that these treatments can keep people out of the hospital. That will help both the people and the hospitals,” said Dr. Margaret Fisher, a pediatric infectious disease specialist with Monmouth Medical Center, an RWJBarnabas hospital, who also serves on the department’s COVID-19 advisory committee. Hospital capacity has been a concern for health and policy leaders throughout the pandemic.
While the monoclonal antibody treatment involves a one-time infusion, clinicians said patients are sent home with ongoing support. Both RWJBarnabas Health and Inspira Health have developed wraparound programs that involve regular monitoring of blood-sugar and oxygen levels — processes that can now be done at home, thanks to new technology — and follow-up visits by telemedicine.
According to the anecdotal feedback to RWJBarnabas clinicians, patients throughout the state find the treatment “amazing,” Freer said.