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In a new study, researchers from Intermountain Healthcare have found that treating high-risk COVID-19 patients with a monoclonal antibody treatment reduced severe illness and hospitalizations by more than 50 percent and saved many patients from dying due to complications from the virus.
The key to effectively reducing severe illness, hospitalizations, and deaths, is that the treatment must be administered within seven days of symptom onset of COVID.
Given the documented success of the treatment, and in light of the major COVID Delta variant surge in the United States, researchers say more resources are needed to fund and expand treatment for high-risk patients.
“In a real-world application, we found that these monoclonal antibodies are as effective as clinical trial results suggested,” said the study’s lead author, Brandon Webb, MD, infectious diseases physician at Intermountain Healthcare. “Based on our findings, we recommend putting resources towards monoclonal treatment programs because they help patients avoid poor outcomes, and because they are a powerful tool to prevent overflowing hospitals.”
Monoclonal antibodies are a drug treatment created to mimic the body’s natural immune response to COVID-19, designed to stick to the virus’ “spike” protein and neutralize it.
Getting vaccinated against COVID-19 remains the most effective way to prevent severe disease and death. However, for patients who do contract COVID-19, especially those at high risk for complications, monoclonal antibodies are a vital tool, researchers say.
“It’s critical that patients be tested early in their symptoms because these treatments only work within the first seven days of symptoms onset, so access to testing is key,” Dr. Webb stressed.
The Intermountain Healthcare study, published in Open Forum Infectious Diseases, examined 594 high-risk, ambulatory patients at Intermountain hospitals who received either bamlanivimab (made by Eli Lilly) or casirivimab/imdevimab (made by Regeneron) infusions within seven days of the onset of symptoms in December 2020 and January 2021.
The Intermountain researchers compared the patient’s health outcomes to patients from two different control groups, one drawn from the electronic health records of similar high-risk patients who were ill from July to November 2020 (when treatments were not available), and another group of patients from December 2020 and January 2021 who did not receive treatment.
When compared to 5,536 patients who did not receive a monoclonal antibody infusion, those who did were 31 percent less likely to need either emergency care or hospital admission and 57 percent less likely to require hospitalization alone, according to the study.
In fact, their mortality rate in the monoclonal treatment group was also 0.2 percent (one death) compared to 1.0 percent of the historical control group (71 deaths) and 1.0 percent of the post-implementation control group (57 deaths), researchers found.
Researchers also found that complications from monoclonal aintibody treatments were very rare, on par with those of any kind of infusion treatment.
“We suspected that these monoclonal antibody treatments would be safe for patients based on results from clinical trials, but we were excited to find that these treatments can be very safely delivered to a variety of patients in a real-world setting,” said Dr. Webb.
The study was conducted when the Alpha Variant, also known as the UK Variant, was the dominant COVID-19 strain found in the U.S. Additional research has found that bamlanivimab is not effective against the Delta variant, now the dominant strain in the U.S., so all monoclonal treatments given at this time are with casirivimab/imdevimab, said Dr. Webb.
As effective as these monoclonal antibody infusions are, widespread implementation is limited by challenging logistics, such as finding locations that can do infusion treatments of actively sick patients without putting other infusion patients, like those with cancer, at risk – and limited clinical resources.
In order to most effectively deploy monoclonal antibody treatments, a consortium of Utah health leaders, including those from Intermountain Healthcare and the Utah Department of Health, have created an Eligibility Criteria and a Utah COVID-19 Risk Score Calculator to determine who should receive a transfusion.
To be considered for monoclonal antibody treatment, patients must be over 18 years old, have a positive COVID-19 test, be symptomatic, and be no more than seven days from the onset of symptoms.
These candidates don’t require new supplemental oxygen, and aren’t sick enough to need hospitalization.
The Utah COVID-19 Risk Score Calculator, which was validated on 20,000 patients to determine it accurately predicted who would become very sick with COVID-19, then identifies who is most at risk for severe complications, and including factors like age, gender and existing comorbidities.
Patients who test positive for COVID-19 and score high on the risk calculator are identified by Intermountain and contacted by care navigators to schedule treatment at one of 24 Intermountain infusion sites across the state. Patients may also be referred for treatment by their healthcare provider, or identified for treatment in the emergency department.
The locations of these sites mean that no patient along the I-15 corridor in Utah is more than a one-hour drive from a treatment center. For most patients, from the time they undergo COVID-19 testing to when they receive their monoclonal infusion takes about 60 hours.
The Intermountain monoclonal antibody program and Utah state allocation process was recently highlighted for efforts to enhance patient access and healthcare equity by the Department of Health and Human Services on their CombatCOVID.org website.
Other members of the research team include: Whitney Buckel, Todd Vento, Allison M. Butler, Nancy Grisel, Samuel M Brown, Ithan D. Peltan, Emily S. Spivak, Mark Shah, and Theadora Sakata, Anthony Wallin, Eddie Stenehjem, Greg Poulsen, and Joseph Bledsoe.