scholarly journals Emergency department use of monoclonal antibody therapy in high risk COVID positive patients

2021 ◽  
Vol 10 (2) ◽  
pp. 38
Author(s):  
Andrew R. Barbera ◽  
Kayla Wilson ◽  
James D. Melton III ◽  
Fred Blind ◽  
Donna M. Bhisitkul ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
High Risk ◽  
Large Scale ◽  
Best Practice ◽  
Antibody Therapy ◽  
Monoclonal Antibody Therapy ◽  
Regional Health ◽  
Staff Members ◽  
Medical Centers

Background: There have been many perceived barriers to the implementation of the mass use of monoclonal antibody therapy following the Food and Drug Administration’s Emergency Use Authorization in November 2020. These barriers include identifying eligible patients, physical resources including trained staff members, space, and materials for the administration away from others to reduce transmission, and cost of the resources. However, Lakeland Regional Health was able to create a safe and efficient protocol to administer Bamlanivimab in the treatment of high risk COVID positive patients and initiate this proposed pathway within 24 hours of receipt of the first shipment of medication.Methods: Critical to the development and success of this protocol was a multi-disciplinary approach focused on identifying and utilizing preexisting resources to ensure safe and efficient administration of this treatment to as many eligible patients as possible. Another crucial aspect was the utilization of the emergency department providers for identifying high risk eligible patients and as a safe and effective treatment setting.Results: This article is intended to demonstrate a best practice pathway to identify and administer Bamlanivimab, or similar treatments, and will not discuss outcomes or efficacy of the medication. To date Lakeland Regional Health has successfully treated over 1,000 high risk COVID-19 positive patients within our community.Conclusions: By identifying and utilizing similar resources and pathways available at individual medical centers, it is possible to safely and efficiently treat high risk COVID positive patients with monoclonal antibody therapy on a large scale.

scholarly journals 31 Emergency Department-Based Monoclonal Antibody Therapy for Patients With Mild to Moderate COVID-19

2021 ◽  
Vol 78 (2) ◽  
pp. S15
Author(s):  
C. Lim ◽  
E. Eiting ◽  
A. O'Neill ◽  
R. Farraj ◽  
S. Koshy ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
Antibody Therapy ◽  
Monoclonal Antibody Therapy

scholarly journals Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19

2021 ◽  
Vol 12 ◽  
pp. 215013272110192
Author(s):  
Dennis M. Bierle ◽  
Ravindra Ganesh ◽  
Caroline G. Wilker ◽  
Sara N. Hanson ◽  
Darcie E. Moehnke ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
High Risk ◽  
Clinical Outcomes ◽  
Antibody Therapy ◽  
Cultural Factors ◽  
Monoclonal Antibody Therapy ◽  
Antibody Treatment ◽  
Medical Comorbidities ◽  
Monoclonal Antibody Treatment ◽  
Social And Cultural Factors

Background The clinical outcomes of patients who decline anti-spike monoclonal antibody therapies for coronavirus disease-2019 (COVID-19) is not known. Factors associated with the decision to accept or decline the offer for anti-spike monoclonal antibody therapies are not established. This study aimed to identify factors impacting the decision to consent for monoclonal antibody therapies and assess the differences in clinical outcomes of patients who accepted compared to those who declined these therapies. Methods This retrospective cohort study enrolled 2820 adult patients who were offered monoclonal antibody therapies, bamlanivimab and casirivimab-imdevimab, for COVID-19 at Mayo Clinic in the Midwest between 11/19/2020 and 12/31/2020. The primary endpoint is the decision to accept or decline monoclonal antibody treatment. Secondary endpoints were patient-level factors that could have impacted the decision to accept treatment (age, gender, race, ethnicity, primary language spoken, and medical comorbidities). The main clinical endpoint was hospitalization within 28 days of COVID-19 diagnosis. Results 59.1% (n = 1669) chose to accept monoclonal antibody therapy, and 40.9% (n = 1151) chose to decline the offer for treatment. Patients were more likely to accept treatment if they were non-Hispanic White, English speaking, identified a spouse or life partner, had a religious affiliation, and possessed more medical comorbidities. Overall, 28-day hospitalization rate was 2.6% (n = 72/2820) and was higher among those who declined (3.3%) than those who accepted monoclonal antibody therapy (2.0%; Rate Ratio = 0.62, 95% Confidence Interval, 0.39-0.98). Conclusions Despite having more comorbidities, patients who accepted monoclonal antibody treatments had a lower rate of hospitalization compared to patients who declined treatment. Several social and cultural factors were associated with the decision to decline therapy, including race, language, ethnicity, and lack of social support. These findings can inform public health efforts to reduce social disparities in the treatment of COVID-19 and increase utilization of monoclonal antibody therapies in high risk populations.

scholarly journals 526. Implementation of Use of Monoclonal Antibody Therapy in a Large Academic Center for the Outpatient Treatment of Covid-19: Impact on 30 Day Hospitalization Rates, ED Visits and Death

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S364-S364
Author(s):  
Azra Bhimani ◽  
Vinay Srinivasan ◽  
Stacey Weinstein ◽  
Nathan Clemons ◽  
Quanna Batiste ◽  
...  
Keyword(s):  
Emergency Department ◽  
Monoclonal Antibody ◽  
Treatment Failure ◽  
Real World ◽  
Hospital Admissions ◽  
Antibody Therapy ◽  
Outpatient Setting ◽  
Hospitalized Patients ◽  
Monoclonal Antibody Therapy ◽  
Ed Visits

Abstract Background Monoclonal Antibody Therapy (MAbs) has been shown to reduce rates of ED visits and hospitalizations in patients at risk for severe Covid-19 infection in clinical trials. Since November, three Mabs received emergency use authorization: Bamlanivimab (Bam), Bamlanivimab/Etesevimab (Bam/Ete) and Casirivimab/Imdevimab (Casi/imdevi). We describe here the real-world effectiveness of implementing early MAb therapy in the outpatient setting for individuals with Covid-19 at high risk of progression. Methods We examined the records of 808 UCLA Health patients with a confirmed positive SARS-CoV2 PCR test who were either referred for outpatient Mab therapy or received Mab treatment in the emergency department (ED) between December 10, 2020, and May 3, 2021. The primary outcome of our analysis was the combined 30-day incidence of emergency department visits, hospitalizations, or death following the date of referral. SARS-CoV2 isolates of hospitalized patients who had received Mabs were sequenced to determine the presence of variants. Results Of 808 patients, 383 were referred for treatment but did not receive treatment, 109 received Mabs in the ED and 316 patients were treated in an outpatient setting. Composite 30-day mortality, ED visits and hospital admissions were significantly reduced in the combination therapy group (Bam/Ete or Cas/Imd) compared with monotherapy (Bam alone) or no treatment groups (aHR 0.16, 95% CI .038, .67). Significant factors associated with the composite outcome included: history of lung disease (HR 4.46, 95% CI 2.89-6.90), cardiovascular disease (HR 1.87, 95% CI 1.12-3.12), kidney disease (HR 2.04, 95% CI 1.27-3.25), and immunocompromised state (HR 3.24, 95% CI 1.02-10.26) as well as high social vulnerability index (HR 1.87, 95% CI 1.13-3.10). Over one-third of hospitalized patients who had received Mabs were confirmed to have the California variant (B.1.427/29) (Figure 1). Figure 1. Covid-19 MAB Treatment Failure Lineages Conclusion Our data show that in a real-world setting, combination monoclonal antibody therapy, not monotherapy, significantly reduced ED visits and hospital admissions, likely due to the presence of the California variants. High socioeconomic vulnerability and certain medical conditions increased risk of treatment failure. Disclosures Omai Garner, PhD, D(ABMM), Beckman Coulter (Scientific Research Study Investigator)

scholarly journals Initial Guidance on Use of Monoclonal Antibody Therapy for Treatment of COVID-19 in Children and Adolescents

2021 ◽  
Author(s):  
Joshua Wolf ◽  
Mark J Abzug ◽  
Rachel L Wattier ◽  
Paul K Sue ◽  
Surabhi B Vora ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
High Risk ◽  
Infectious Diseases ◽  
Children And Adolescents ◽  
Severe Disease ◽  
Antibody Therapy ◽  
Pediatric Intensive Care ◽  
Risk Groups ◽  
Monoclonal Antibody Therapy ◽  
Routine Administration

Abstract Background In November 2020, the US Food and Drug Administration (FDA) provided Emergency Use Authorizations (EUA) for two novel virus-neutralizing monoclonal antibody therapies, bamlanivimab, and REGN-COV2 (casirivimab plus imdevimab), for the treatment of mild to moderate COVID-19 in adolescents and adults in specified high-risk groups. This has challenged clinicians to determine the best approach to use of these products. Methods A panel of experts in pediatric infectious diseases, pediatric infectious diseases pharmacy, pediatric intensive care medicine, and pediatric hematology from 29 geographically diverse North American institutions was convened. Through a series of teleconferences and web-based surveys, a guidance statement was developed and refined based on review of the best available evidence and expert opinion. Results The course of COVID-19 in children and adolescents is typically mild and there is no high-quality evidence supporting any high risk groups. There is no evidence for safety and efficacy of monoclonal antibody therapy for treatment of COVID-19 in children or adolescents, limited evidence of modest benefit in adults, and evidence for potential harm associated with infusion reactions or anaphylaxis. Conclusions Based on evidence available as of December 20, 2020, the panel suggests against routine administration of monoclonal antibody therapy (bamlanivimab, or casirivimab and imdevimab), for treatment of COVID-19 in children or adolescents, including those designated by the FDA as at high risk of progression to hospitalization or severe disease. Clinicians and health systems choosing to use these agents on an individualized basis should consider risk factors supported by pediatric-specific evidence, and ensure implementation of a system for safe and timely administration that does not exacerbate existing healthcare disparities.

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