Original Research
Sunday, November 12, 2023
12:45 PM–02:15 PM
Abstract
Introduction:
During the COVID-19 pandemic, monoclonal antibodies (mAb) and oral antiviral agents represented two treatment options for mild-to-moderate COVID-19 in non-hospitalized patients at high risk of progression to severe infection. At Cleveland Clinic Health System (CCHS), high-risk criteria were created and antiviral therapy utilization was closely monitored.
Research Question or Hypothesis:
What is the rate of hospitalization within 28 days of treatment with mAb or oral antivirals for high-risk, non-hospitalized patients with mild-to-moderate COVID-19?
Study Design:
Retrospective, multi-center, cohort study
Methods:
Adult patients prescribed molnupiravir, nirmatrelvir/ritonavir, or a COVID-19 mAb from 1/1/2022 to 12/31/2022 were included. Duplicative prescriptions were reviewed and patients receiving multiple therapies were excluded. Only the first instance of outpatient COVID-19 treatment per patient was included. Using Stata software v16.1, descriptive statistics evaluated categorical variables as frequency with proportion and continuous variables as mean with standard deviation or median with interquartile range. Normality was determined by a significant Shapiro-Wilk’s test.
Results:
A total of 25,657 patients were included. An average patient was a 65 year old, White (87%), non-Hispanic (95%) female (58%). Some pre-existing conditions included vascular disease (11.5%), hypertension (8.5%), neoplasm (6.6%), and transplanted organ or tissue (0.72%). More patients received oral nirmatrelvir/ritonavir (70.8%) and molnupiravir (18.9%) compared to bebtelovimab (7.2%) and sotrovimab (3%). Primary outcome showed 1.9% hospitalization within 28 days of therapy (n=487 of 25,657). Nirmatrelvir/ritonavir (0.8%) had the highest hospitalization rate, followed by molnupiravir (0.5%), bebtelovimab (0.38%) and sotrovimab (0.1%). Among hospitalized patients, 104 of 487 patients (21%) required intensive care unit visit within 28 days of therapy.
Conclusion:
Hospitalization within 28 days remained low after receiving mAb or oral antivirals in high-risk non-hospitalized patients with mild-to-moderate COVID-19. Further studies are needed to determine risk factors for hospitalization especially in special patient populations.
Presenting Author
ChungYun Kim PharmD, BCIDPCleveland Clinic Health System
Authors
Tricia Bravo MD
Cleveland Clinic Health System
Cassandra Calabrese DO
Cleveland Clinic Health System
Alice Kim MD, MBA
Cleveland Clinic Health System
Stephanie McGuire MSDA
Cleveland Clinic Health System
Steven Gordon MD
Cleveland Clinic Health System
Chanda Mullen PhD
Cleveland Clinic Akron General
Andrea Pallotta PharmD, BCPS, BCIDP, AAHIVP
Cleveland Clinic