Abstract
BackgroundAnti-SARS-CoV-2 monoclonal antibodies afford prompt immunity, have demonstrated reduction in severe COVID-19 in high risk ambulatory patients, and are available through Emergency Use Authorization. Challenges exist, however, to widespread utilization. MethodsThis operations study 11/23/20-4/30/21 identified patients meeting monoclonal AB EUA criteria by test results or referral. Outreach to harder-hit neighborhoods included connecting with primary care teams and testing sites. Infusion centers with staff trained in infection control, rapid response and drug preparation were utilized. The primary study outcome was treatment of qualifying patients. Secondary outcomes included infusion complications, hospitalization/death, and symptom resolution. Investigational review board approval was obtained.Results367 patients were treated: mean age of 63, 201(55%) male, 276(75%) white, 54(15%) black. All patients had a first positive direct SARS-CoV-2 test within 10 days, 232(63%) had > 1 high-risk qualification, 32(9%) were vaccinated for SARS-CoV-2. Of patients with available zipcodes, 135(38%) had a Community Need Index >3.5 and 157(45%) a Social Vulnerability Index >0.5. 190(52%) received bamlanivimab, 93(25%) casirivimab/imdevimab, 84(23%) bamlanivimab/etesevimab. Four patients experienced infusion reaction, 1 with anaphylaxis. 172(73%) of 236 patients were symptom free at day 5. 20 patients (5%) were hospitalized for COVID-19 within 30 days with a median time from symptom onset to infusion of 7 days, 11(55%) were admitted within 24 hours, 1 died. Patient Characteristics COVID-19 course Community Need Index and Social Vulnerability Index by Zipcode ConclusionOur study demonstrates that treatment with anti-SARS-CoV-2 monoclonal antibodies is feasible in a high resource setting. There were no related SARS-CoV-2 exposures and therapy was well tolerated. Trials of anti-SARS-CoV-2 monoclonal antibodies have reported lower rates of hospitalizations in treated patients than we found. This may reflect the expanded time frame for EUA therapy as compared to clinical trials, differences in real world patients or viral variants. Given potential benefit in unvaccinated patients or those at risk for poor vaccine response, the equitable utilization of anti-SARS-CoV-2 monoclonal antibody therapy in early COVID-19 should remain a focus for researchers and clinicians. Disclosures All Authors: No reported disclosures
Highlights
Higher rates of COVID-19 related hospitalization and death are reported in patients with underlying health conditions and advanced age as compared to the general population
The U.S Food and Drug Administration (FDA) has issued Emergency Use Authorization for four monoclonal antibody products requiring intravenous administration including bamlanivimab monotherapy, casirivimab/imdevimab, bamlanivimab/etesevimab and sotrovimab for the treatment of early, mild-moderate COVID-19 in high-risk outpatients as well as inpatients not hospitalized for COVID-19
Our study demonstrates that treatment with anti-SARS-CoV-2 neutralizing monoclonal antibodies is feasible in a high resource urban health care setting
Summary
Higher rates of COVID-19 related hospitalization and death are reported in patients with underlying health conditions and advanced age as compared to the general population. While polyclonal immunity generated by vaccines has demonstrated protection against severe disease, vaccine response takes time and may be inadequate in some high-risk populations.[1] Treatment with anti-SARS-CoV-2 neutralizing monoclonal antibodies affords prompt, passive humoral immunity and has been shown in randomized, controlled trials to reduce rates of hospitalization and death from COVID-19 in high-risk ambulatory patients treated early in the course of infection.[2,3] The U.S Food and Drug Administration (FDA) has issued Emergency Use Authorization for four monoclonal antibody products requiring intravenous administration including bamlanivimab monotherapy (since retracted), casirivimab/imdevimab, bamlanivimab/etesevimab (since retracted) and sotrovimab for the treatment of early, mild-moderate COVID-19 in high-risk outpatients as well as inpatients not hospitalized for COVID-19. How to effectively identify qualifying patients, arrange for infusion and administer therapy, poses challenges to the widespread, equitable utilization of these potentially lifesaving therapies
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