Implementation of a COVID-19 Monoclonal Antibody Program

The COVID-19 pandemic necessitated the development of therapeutic approaches to combat the SAR-CoV-2 virus. In late 2020, monoclonal antibody therapies were among the first COVID-19 therapeutics to receive emergency use authorization from the U.S. Food and Drug Administration. In January 2021, a panel of pediatric experts released a consensus statement recommending against routine use of COVID-19 monoclonal antibody therapies in children and adolescents due to limited efficacy or safety data and in support of individualized risk assessments when considering use of these therapies.

“When the first monoclonal antibody treatment was developed, it was not clear how this new therapy, which was still considered investigational, would impact pediatric patients with COVID-19, and it was a scarce resource. So, we felt it was important to set up a program to offer outpatient treatment for children who had the highest risk of developing severe disease,” says Joshua Watson, MD, pediatric infectious disease specialist at Nationwide Children’s Hospital.

“Procurement of the drug was difficult, and we were often told how many doses the hospital would receive only a week in advance. This required us to be very nimble, and the program was a success because of the commitment and effort of the provider team and many other key personnel, including those in nursing and pharmacy,” adds Jill Blind, PharmD, CCRP, pharmacy manager of Investigational Drug Service & Controlled Substances at Nationwide Children’s.

Drs. Watson and Blind worked closely with a multidisciplinary team to establish a COVID-19 monoclonal antibody referral process that worked fluidly as doses became available and new therapies were developed. They recently published a report in the Journal of the Pediatric Infectious Diseases Society describing the process and clinical outcomes of patients who received a SARS-CoV-2 neutralizing monoclonal antibody infusion at the hospital.

Their standardized COVID-19 monoclonal antibody referral and approval process incorporated a tiered allocation system based on patients’ underlying medical conditions.

Between Nov. 27, 2020 and Jan. 26, 2022, 182 patients received a COVID-19 monoclonal antibody infusion at Nationwide Children’s. the patients were between 10 months and 21 years of age. Overall, 7 patients (4%) experienced suspected adverse reactions during the infusion, and 15 (8%) patients required a COVID-19 related visit (primary care provider, emergency department, or hospitalization) within 30 days of the monoclonal antibody infusion.

“Although the current SARS-CoV-2 variants are showing resistance to the available monoclonal antibodies, other outpatient therapies have been developed for COVID-19. Thus, this program continues to provide a valuable framework within our hospital and for other hospitals that may want to establish such a program,” says Dr. Watson.

This feature was published in the Spring/Summer 2023 issue. Download the full issue.