Vanderbilt University Medical Center has a new weapon in the fight against COVID-19 — an investigational antibody treatment approved last month for emergency use in COVID-19 outpatients at high risk of developing severe disease or requiring hospital care.
The antibody, called bamlanivimab, was discovered by Canadian biotech firm AbCellera and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Developed in collaboration with Eli Lilly and Co., it is given by intravenous infusion.
Because SARS-CoV-2, the virus that causes COVID-19, is highly contagious, VUMC opened a self-contained COVID Infusion Clinic on Nov. 18, nine days after the investigational therapy was granted emergency use authorization by the Food and Drug Administration (FDA).
Since then, more than 100 outpatients at VUMC with mild to moderate symptoms of COVID-19 have received bamlanivimab, said Karen Bloch, MD, MPH, medical director of the COVID Infusion Clinic and professor of Medicine.
Laboratory-made “monoclonal” antibodies that target and neutralize SARS-CoV-2 “are really an important new modality for treating patients who are infected … and particularly those who are at highest risk for developing severe disease,” Bloch said.
“Right now, we don’t have anything to prevent infection,” she said, although the FDA is in the process of granting emergency use authorization to one or perhaps two investigational COVID-19 vaccines. “This is a secondary measure … to decrease the severity of infection,” Bloch said.
That conclusion is based on a randomized, controlled clinical trial that found 3% of high-risk COVID-19 patients required hospital or emergency room care within 28 days after receiving bamlanivimab, compared to 10% of patients who were given an inactive placebo.
Bamlanivimab is the first laboratory-made “monoclonal” antibody against COVID-19 to receive FDA approval. On Nov. 21, a cocktail of two antibodies developed by New York-based Regeneron Pharmaceuticals, which was given to President Trump this fall when he tested positive for COVID-19, received emergency use authorization.
The Tennessee Department of Health began distributing a limited supply of Regeneron’s antibody cocktail — casirivimab and imdevimab — to health care facilities around the state on Nov. 24. VUMC will begin providing it to patients later this month, Bloch said.
Another combination of antibodies discovered at VUMC and developed by the global biopharmaceutical company AstraZeneca for the treatment of COVID-19 is in phase 3 clinical trials.
Currently there are six infusion chairs in VUMC’s COVID Infusion Clinic. As demand for the service and staffing increase, the clinic is anticipated to be open seven days a week.
While there is no charge for the antibody therapy because it is investigational, patients must meet criteria determined by a multidisciplinary committee of clinicians at VUMC to ensure that the limited supply is available to those who would benefit the most.
These include patients who are 65 years old and older, those with immunosuppression, and those with comorbidities (medical conditions) that place them at increased risk for hospitalization.
The onset of COVID-19 symptoms also must have occurred within the previous seven days. “It appears the longer you’re symptomatic, the less effective this treatment is,” Bloch said.
The provision of monoclonal antibody therapy at VUMC has required “an extraordinary amount of work” by individuals representing several disciplines throughout the Medical Center, she noted.
Among them were the teams in the central adult hospital pharmacy and Vanderbilt Medical Group clinic pharmacy, said Mark Sullivan, PharmD, MBA, Associate Chief Pharmacy Officer for the Vanderbilt University Hospital & Clinics.
“The central pharmacy sterile products team has done a super job of tracking scheduled visits and providing the infusions to mitigate wait times for patients and staff,” he said.
