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Clinical Outcomes of Monoclonal Antibody Therapy During a COVID-19 Outbreak in a Skilled Nursing Facility - Arizona, 2021

Dale et al., Journal of the American Geriatrics Society, doi:10.1111/jgs.17705

Feb 2022

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Bamlanivimab/etesevimab

20th treatment shown to reduce risk in May 2021

^*, now known with p = 0.00029 from 20 studies, recognized in 4 countries. Efficacy is variant dependent.

Lower risk for mortality, hospitalization, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,000+ studies for 60+ treatments. c19early.org

Retrospective 75 COVID+ patients in a skilled nursing facility in the USA, 56 treated within a median of 2 days from symptom onset with bamlanivimab, showing significantly lower mortality with treatment.

Efficacy is highly variant dependent. In Vitro research suggests a lack of efficacy for omicron Haars, Liu, Pochtovyi, Sheward, VanBlargan.

1. Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.mdpi.com, doi.org.

2. Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.biorxiv.org, doi.org.

3. Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.mdpi.com, doi.org.

4. Sheward et al., Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), bioRxiv, doi:10.1101/2021.12.19.473354.biorxiv.org, doi.org.

5. VanBlargan et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, bioRxiv, doi:10.1101/2021.12.15.472828.biorxiv.org, doi.org.

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risk of death, 89.2% lower, RR 0.11, p = 0.010, treatment 5 of 56 (8.9%), control 9 of 19 (47.4%), NNT 2.6, adjusted per study, odds ratio converted to relative risk, multivariable.

risk of progression, 86.3% lower, RR 0.14, p = 0.002, treatment 6 of 56 (10.7%), control 10 of 19 (52.6%), NNT 2.4, adjusted per study, odds ratio converted to relative risk, oxygen therapy, multivariable.

risk of progression, 53.8% lower, RR 0.46, p = 0.35, treatment 6 of 56 (10.7%), control 3 of 19 (15.8%), adjusted per study, odds ratio converted to relative risk, ER visit or hospitalization, multivariable.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Dale et al., 9 Feb 2022, retrospective, USA, peer-reviewed, 14 authors, average treatment delay 2.0 days.

This Paper Bamlaniv../e..All

Clinical outcomes of monoclonal antibody therapy during a COVID ‐19 outbreak in a skilled nursing facility—Arizona, 2021

PhD, MPH Ariella P Dale, MD, MPH Matthew J Hudson, RN Darunee Armenta, RD, LNHA Heather Friebus, PhD Katherine D Ellingson, MPH Kat Davis, MD Theresa Cullen, MPH Shane Brady, MPH Kenneth K Komatsu, MD Nimalie D Stone, MD Timothy M Uyeki, Kara Jacobs Slifka, Carlos M Pérez‐vélez, MD Amelia A Keaton

Journal of the American Geriatrics Society, doi:10.1111/jgs.17705

 Receipt of monoclonal antibody therapy significantly reduced odds of mortality and need for supplemental oxygen in skilled nursing facility residents with mild-to-moderate COVID-19.  Use of monoclonal antibody therapy in skilled nursing facilities requires close partnership with local health departments and healthcare entities Why does this paper matter? This paper describes the use of monoclonal antibody therapy in the setting of a COVID-19 outbreak at a skilled nursing facility. Additionally, this paper reaffirms that use of monoclonal antibody therapies in persons with mild-to-moderate COVID-19 prevents severe outcomes such as death.

Author contributions: All authors contributed to conception of this manuscript, and from that start point, shared in writing and revision process. Sponsors Role: No funding was received associated with this manuscript. There were no sponsors involved in the conceptualization or production of this manuscript. Accepted Article This article is protected by copyright. All rights reserved. N/A cannot be calculated due too few of observations. Accepted Article Accepted Article

References

Alam, Mahmud, Aggarwal, Clinical Impact of the Early Use of Monoclonal Antibody LY-CoV555 (Bamlanivimab) on Mortality and Hospitalization Among Elderly Nursing Home Patients: A Multicenter Retrospective Study, Cureus, doi:10.7759/cureus.14933

Bagchi, Mak, Li, Rates of COVID-19 among residents and staff members in nursing homes-United States, Morbidity and Mortality Weekly Report

Bariola, Mccreary, Wadas, Impact of monoclonal antibody treatment on hospitalization and mortality among non-hospitalized adults with SARS-CoV-2 infection

Cdc, SARS-CoV-2 Variant Classifications and Definitions

Cohen, Nirula, Mulligan, Effect of Bamlanivimab vs Placebo on Incidence of COVID-19 Among Residents and Staff of Skilled Nursing and Assisted Living Facilities: A Randomized Clinical Trial, JAMA, doi:10.1001/jama.2021.8828

Dale, Hudson, Cullen, Administration of Bamlanivimab to Skilled Nursing Facility Residents during a COVID-19 Outbreak, Journal of the American Medical Directors Association

Garg, Kim, Whitaker, Hospitalization rates and characteristics of patients hospitalized with laboratory-confirmed coronavirus disease 2019-COVID-NET, 14 States

Gottlieb, Nirula, Chen, Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial, Jama

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Williamson, Walker, Bhaskaran, Factors associated with COVID-19-related death using OpenSAFELY, Nature

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