Leveraging antimicrobial stewardship programs was crucial to ensure COVID-19 hospital inpatients received monoclonal antibody therapy quickly and safely.
COVID-19 monoclonal antibodies, though less effective at neutralizing the Omicron variant, have been proven to reduce disease progression in high-risk patients. Obstacles to utilizing monoclonal antibodies include Emergency Use Authorization (EUA) requirements, and the necessity of early administration of the intravenous treatment.
One study, presented during this week’s Making a Difference in Infectious Diseases (MAD-ID) 2022 Annual Meeting, noted that although monoclonal antibodies are not fully authorized for patients hospitalized with COVID-19, patients hospitalized for other reasons may be eligible for the therapy. Thus, the investigators aimed to implement a quality improvement initiative for the safe and appropriate use of COVID-19 monoclonal antibodies in hospital patients.
A pharmacist-driven process for inpatient monoclonal antibody therapy was implemented in June 2021 at a southeast Michigan health system. Healthcare providers identified hospitalized patients, obtained consent from either the patients or their caregivers, and filed a “pharmacy to dose monoclonal antibody for COVID-19” order in the electronic medical record.
Then, antimicrobial stewardship pharmacists ensured EUA criteria were met. They assessed requirement fulfillment during the dayshift and established a standard administration time in the evening. The pharmacists clarified criteria with the providers as needed, before ordering monoclonal antibodies in accordance with local supply. The pharmacists used a standardized oral set, which included one-time, as-needed medications to manage infusion reactions. All infusions were monitored by a nurse for 1 hour for hypersensitivity reactions.
After monoclonal antibody implementation, investigators conducted a cross-sectional, retrospective study from June-December 2021. The study included a total of 38 patients, all of whom received monoclonal antibody therapy while hospitalized with COVID-19. The antimicrobial stewardship pharmacists completed paperwork required by the state of Michigan to administer monoclonal antibodies under EUA.
During the study period, there were 352 requests for monoclonal antibody therapy and 193 administrations (55%). The 45% of requests that went unfulfilled were either due to patient discharge or unfulfilled criteria. Among the patients who did receive monoclonal antibodies, the average number of high-risk criteria met per patient was 3.5. The most common of these were BMI over 25 kg/m2 (87%), cardiovascular disease (79%), and age above 65 years (58%).
The patients received monoclonal antibodies at an average of 3 days after COVID-19 symptom onset, and an average of 1 day after testing positive for COVID-19. The median length of hospital stay was 10.2 days. A total of 18.4% of patients received COVID-19 treatment after infusion, 10.5% died within 2 weeks of hospital discharge, and 7.9% were readmitted.
The investigators concluded that adapting and utilizing existing antimicrobial stewardship programs was essential in administering monoclonal antibodies to COVID-19 inpatients safely and quickly.
This study, “Implementation of COVID-19 Monoclonal Antibody Therapy for Hospitalized Patients,” was accepted as an abstract for the Making a Difference in Infectious Diseases (MAD-ID) 2022 Annual Meeting.