500. A Real-World Cohort Study of Bamlanivimab Versus Bamlanivimab-Etesevimab for Non-severe COVID-19

Abstract Background Anti-spike monoclonal antibodies (mAb) including Bamlanivimab (BAM) and Bamlanivimab-Etesevimab (BAM/E) have shown reduced hospitalization rates for non-severe coronavirus disease 2019 (COVID-19) in clinical trials. Recent studies provided real-world hospitalization rates for BAM. But, similar data on those who received BAM/E are lacking. In spring 2021, Michigan experienced a surge of COVID-19 with more cases per capita than any other state. We sought to quantify the impact of BAM monotherapy versus BAM/E combination on hospitalization and mortality among a real-world high-risk cohort of outpatients with COVID-19. Methods This retrospective cohort study evaluated outpatients ≥18 years with laboratory-confirmed mild/moderate COVID-19 who received mAb in a Detroit health system based on emergency use authorization criteria. Inclusion began on December 3rd 2020 with BAM monotherapy, changed to BAM/E combination on March 27, 2021, and included patients until April 19th 2021 (Figure 1). Demographics, comorbidities, and clinical characteristics were compared between patients who received BAM verses BAM/E using Chi-square and Mann-Whitney U test. Primary outcome was 30-day COVID-19 related hospitalization. Secondary outcomes were 30-day mortality and length of stay (LOS). Inclusion began on December 3rd 2020 with BAM monotherapy, changed to BAM/E combination on March 27, 2021, and included patients until April 19th 2021. In spring 2021, Michigan experienced a surge of COVID-19 with more cases per capita than any other state resulting in a large sample of real-world patients for analysis. Results 643 patients received mAb (294 in BAM group and 349 in BAM/E group). Patients in the BAM/E cohort were younger and more obese with lower rates of diabetes, myocardial infarction, and cancer. Other characteristics were similar (Table 1). BAM/E patients had longer time from symptom onset to infusion (6 vs 4 days, p< 0.001). COVID-19 related 30-day hospitalization rates did not differ between groups (7.8 vs 7.2%, p=0.751). LOS and 30-day mortality (1% vs 0.3%, p=0.238) were also similar (Table 2). Patients in the BAM/E cohort were younger and more obese with lower rates of diabetes, myocardial infarction, and cancer. Other characteristics were similar BAM/E patients had longer time from symptom onset to infusion (6 vs 4 days, p<0.001). COVID-19 related 30-day hospitalization rates did not differ between groups. Length of stay and 30-day mortality were also similar. Conclusion Rates of hospitalization in our study were higher than in clinical trials of mAB and may reflect differences in study populations (Table 3). Compared to other real-world studies, our cohort of young, obese, and Black patients, had similar hospitalization rates of 7.5%. The lack of difference in outcomes noted among the mAB formulations in our study may be related to longer time from symptom onset to infusion in the BAM/E combination group. Our patients were older with higher rates of obesity and other comorbidities than those in clinical trials (shown in orange). Compared to other real-world studies (in blue), our cohort of younger, more obese Black patients had similar hospitalization rates of 7.5%. Disclosures All Authors: No reported disclosures

Inclusion began on December 3rd 2020 with BAM monotherapy, changed to BAM/E combination on March 27, 2021, andincluded patients until April 19th 2021. In spring 2021, Michigan experienced a surge of COVID-19 with more cases per capita than any other state resulting in a large sample of real-world patients for analysis.
Results. 643 patients received mAb (294 in BAM group and 349 in BAM/E group). Patients in the BAM/E cohort were younger and more obese with lower rates of diabetes, myocardial infarction, and cancer. Other characteristics were similar (Table  1). BAM/E patients had longer time from symptom onset to infusion (6 vs 4 days, p< 0.001). COVID-19 related 30-day hospitalization rates did not differ between groups (7.8 vs 7.2%, p=0.751). LOS and 30-day mortality (1% vs 0.3%, p=0.238) were also similar (Table 2).
Patients in the BAM/E cohort were younger and more obese with lower rates of diabetes, myocardial infarction, and cancer. Other characteristics were similar BAM/E patients had longer time from symptom onset to infusion (6 vs 4 days, p<0.001). COVID-19 related 30-day hospitalization rates did not differ between groups. Length of stay and 30-day mortality were also similar.
Conclusion. Rates of hospitalization in our study were higher than in clinical trials of mAB and may reflect differences in study populations (Table 3). Compared to other real-world studies, our cohort of young, obese, and Black patients, had similar hospitalization rates of 7.5%. The lack of difference in outcomes noted among the mAB formulations in our study may be related to longer time from symptom onset to infusion in the BAM/E combination group.
Our patients were older with higher rates of obesity and other comorbidities than those in clinical trials (shown in orange). Compared to other real-world studies (in blue), our cohort of younger, more obese Black patients had similar hospitalization rates of 7.5%.
Disclosures. Background. Long-term care facility (LTCF) residents are at increased risk of severe COVID-19, with CMS data indicating > 20% mortality. BLAZE-1 trial noted lower hospitalization rates in high-risk patients receiving monoclonal antibody (mAb) vs placebo (4.2% vs 14.6%) for mild to moderate infections, making it a treatment option for LTCF residents; however, many LTCF lack staff to prepare and administer mAb therapy. To address this need, Region VII Disaster Health Response Ecosystem (R7DHRE) coordinated via NE Medical Emergency Operations Center (NEMEOC) an ASPR pilot project to facilitate infusion of COVID-19 mAb therapeutics for LTCF residents in the state.
Methods. R7DHRE partnered with Great Plains Health, Nebraska DHHS, Nebraska Antimicrobial Stewardship Assessment and Promotion Program (ASAP) and Infection Control Assessment and Promotion Program (ICAP) to surveil cases in the state, establish distribution/administration pathways, and educate providers on mAb therapeutics. A multi-hub-and-spoke model was created to allow LTCF to work with regional hospitals or pharmacy services to administer drug in their facilities, reducing time to therapy and transmission risk associated with patient transport. A centralized request process was created using a REDCap platform and verification of patient eligibility by ASAP. This request link, informational documents, fact sheets, and custom-built order form templates were hosted on a dedicated ASAP webpage, and details were shared during weekly ICAP LTCF webinars. Outcomes data, including 14-and 28-day COVID-related hospitalizations and mortality, were collected using databases from Nebraska Health Information Initiative and Nebraska DHHS.
Results. Through this program, 513 doses were administered to LTCF residents. Average time from symptom onset to infusion was 2.6 days. COVID-related hospitalization and mortality rates were lower than previously reported for LTCF residents (Table 1).  Background. COVID-19 disproportionately results in hospitalization and death in older patients and those with underlying comorbidities. Sotrovimab is a pan-sarbecovirus monoclonal antibody that binds a highly conserved epitope of the SARS-CoV-2 receptor binding domain and has an Fc modification that increases half-life. Sotrovimab retains activity against UK, S. Africa, Brazil, India, New York and California variants in vitro.
Objectives. To evaluate the efficacy and safety of treatment with sotrovimab in high-risk, non-hospitalized patients with mild/moderate COVID-19, as part of the COMET-ICE clinical trial.
Methods. Multicenter, double-blind, phase 3 trial in non-hospitalized patients with symptomatic COVID-19 and ≥1 risk factor for disease progression were randomized 1:1 to an IV infusion of sotrovimab 500 mg or placebo. The primary efficacy endpoint was the proportion of patients with COVID-19 progression, defined as hospitalization > 24 hours or death, due to any cause, ≤29 days of randomization.
Results. The study met the pre-defined primary efficacy endpoint in a preplanned interim analysis: the risk of COVID-19 progression was significantly reduced by 85%