Outcome Comparison of High-Risk Native American Patients Who Did or Did Not Receive Monoclonal Antibody Treatment for COVID-19 | Infectious Diseases | JAMA Network Open | JAMA Network
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Table 1.  Demographic Comparison of Patients Who Did or Did Not Receive Monoclonal Antibody Treatment for COVID-19
Demographic Comparison of Patients Who Did or Did Not Receive Monoclonal Antibody Treatment for COVID-19
Table 2.  Comparison of 30-Day Outcomes Among Patients Who Did or Did Not Receive Monoclonal Antibody Treatment for COVID-19
Comparison of 30-Day Outcomes Among Patients Who Did or Did Not Receive Monoclonal Antibody Treatment for COVID-19
1.
Gottlieb  RL, Nirula  A, Chen  P,  et al.  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. 2021;325(7):632-644. doi:10.1001/jama.2021.0202 PubMedGoogle ScholarCrossref
2.
Weinreich  DM, Sivapalasingam  S, Norton  T,  et al; Trial Investigators.  REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-19.   N Engl J Med. 2021;384(3):238-251. doi:10.1056/NEJMoa2035002 PubMedGoogle ScholarCrossref
3.
US Food and Drug Administration. Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. November 9, 2020. Updated May 14, 2021. Accessed January 29, 2021. https://www.fda.gov/media/145802/download
4.
US Food and Drug Administration. Fact sheet for health care providers: emergency use authorization (EUA) of REGEN-COV (casirivimab and imdevimab). November 21, 2020. Updated July 30, 2021. Accessed January 29, 2021. https://www.fda.gov/media/145611/download
5.
Cheek  JE, Holman  RC, Redd  JT, Haberling  D, Hennessy  TW.  Infectious disease mortality among American Indians and Alaska Natives, 1999-2009.   Am J Public Health. 2014;104(suppl 3):S446-S452. doi:10.2105/AJPH.2013.301721 PubMedGoogle ScholarCrossref
6.
Arrazola  J, Masiello  MM, Joshi  S,  et al.  COVID-19 mortality among American Indian and Alaska Native persons—14 states, January-June 2020.   MMWR Morb Mortal Wkly Rep. 2020;69(49):1853-1856. doi:10.15585/mmwr.mm6949a3 PubMedGoogle ScholarCrossref
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    Research Letter
    Infectious Diseases
    September 21, 2021

    Outcome Comparison of High-Risk Native American Patients Who Did or Did Not Receive Monoclonal Antibody Treatment for COVID-19

    Author Affiliations
    • 1Whiteriver Indian Hospital, Indian Health Service, Whiteriver, Arizona
    JAMA Netw Open. 2021;4(9):e2125866. doi:10.1001/jamanetworkopen.2021.25866
    Introduction

    Treatments for COVID-19 remain urgent and necessary despite increasing vaccine distribution. Studies suggest that monoclonal antibody (mAb) therapies prevent progression in early disease.1,2 In late 2020, the US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for 2 mAb therapies, bamlanivimab and a combination of casirivimab and imdevimab, to treat COVID-19.3,4 However, previous mAb studies1,2 with a total of 852 participants (577 in one study1 and 275 in the other2) did not report a reduction in patient mortality, and only 5 participants across both trials (0.6%) were Native American. We present a retrospective quality improvement study on an early mAb treatment program for high-risk Native American patients at the Whiteriver Service Unit (WRSU), a rural acute care facility that serves as the primary hospital and public health department on the Fort Apache Indian Reservation in eastern Arizona.

    Methods

    For this quality improvement study, all WRSU patients who had a positive COVID-19 test result during the observation period (between December 1, 2020, and February 3, 2021) were screened for mAb treatment eligibility per the EUA. All eligible patients provided oral informed consent. Patients were treated with bamlanivimab or a combination of casirivimab and imdevimab according to manufacturer and FDA guidelines3,4 and monitored for 30 days. Post hoc exploratory analyses compared mAb-treated patients with patients with COVID-19 who met the EUA high-risk criteria but were not treated for various reasons. See the eMethods in the Supplement for additional details. The Tribal Health Board and White Mountain Apache Tribal Council approved the study procedures and their publication. The study followed the Standards for Quality Improvement Reporting Excellence (SQUIRE) reporting guideline.

    Results

    During the observation period, 983 WRSU patients received a positive COVID-19 test result. The median patient age was 32 years (interquartile range [IQR], 17-51 years) and 534 patients (54.3%) were female. Of the 983 patients, 481 (48.9%) met EUA high-risk criteria for treatment and 201 high-risk patients (41.8%) received mAb treatment. The median time from COVID-19 test collection to mAb treatment was 23 hours (IQR, 3-45 hours), and 182 of 201 patients (90.5%) received treatment within 72 hours. The median time from symptom onset to treatment was 2 days (IQR, 1-3 days), and 113 of 149 symptomatic patients (75.8%) were treated within 3 days (Table 1). The mAb-treated patients had a median body mass index (calculated as weight in kilograms divided by height in meters squared) of 35.8 (IQR, 30-40) and a mean (SD) age of 50 (19) years, and 114 (56.7%) met 2 or more high-risk criteria. The mAb-treated patients were older and had more risk factors for severe disease than nonrecipients (Table 1). The 280 high-risk nonrecipients had a mean (SD) age of 43 (19) years, and 125 (44.6%) met 2 or more high-risk criteria. Compared with nonrecipients, the mAb-treated patients had a lower proportion of acute medical visits (59 [29.4%] vs 136 [48.6%]), hospitalizations (35 [17.4%] vs 120 [42.9%]), transfers to outside facilities (4 [2%] vs 26 [9.3%]), intensive care unit admissions (0 vs 12 [4.3%]), and deaths (0 vs 8 [2.9%]) (Table 2). Of the 8 deaths during the observation period, these patients all met the EUA high-risk criteria but did not receive mAb treatment.

    Discussion

    The lower proportion of hospitalizations among mAb-treated patients observed at WRSU is consistent with previous mAb studies,1,2 albeit to a greater degree. To our knowledge, this study is the first to report mAb use for Native American individuals and is among the few studies to report a significantly lower proportion of deaths among patients receiving mAbs. The magnitude of our findings is attributable in part to a higher baseline hospitalization rate. Abiding by EUA criteria meant that eligible WRSU patients, treated and untreated, were at higher risk for severe COVID-19 (eg, higher BMI and more risk factors) compared with prior studies.1,2 Furthermore, Native American individuals experience greater infectious disease mortality, including from COVID-19, which likely increased WRSU hospitalization rates.5,6 The success of the WRSU mAb program is also likely attributable to rapid treatment. The WRSU decreased the time to treatment by integrating contact tracing, clinical outreach, in-house molecular testing, and a unified public health and hospital system that streamlined information exchange. This approach may not be generalizable but is a model for other centralized health systems.

    We recognize several limitations of this study. Retrospective comparisons can result in some misclassification. In particular, some patients in this study were excluded from mAb treatment solely based on symptom severity, per the EUA.3,4 These patients may have progressed to hospitalization even with mAb treatment; however, it is also possible that earlier mAb intervention may have prevented this progression. Given the magnitude of our findings, we believe they are unlikely to be entirely the result of misclassification. Therefore, we assert that the success of the WRSU mAb program suggests that these treatments can be used to great effect in rural, relatively resource-limited settings.

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    Article Information

    Accepted for Publication: July 19, 2021.

    Published: September 21, 2021. doi:10.1001/jamanetworkopen.2021.25866

    Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Close RM et al. JAMA Network Open.

    Corresponding Author: Ryan M. Close, MD, MPH, Whiteriver Indian Hospital, Indian Health Service, 200 W Hospital Dr, PO Box 860, Whiteriver, AZ 85941 (ryan.close@ihs.gov).

    Author Contributions: Dr Close had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr Close and Mr Jones contributed equally to the work.

    Concept and design: Close, Jones, McAuley.

    Acquisition, analysis, or interpretation of data: All authors.

    Drafting of the manuscript: Close, Jones, Jentoft.

    Critical revision of the manuscript for important intellectual content: All authors.

    Statistical analysis: Close, Jones.

    Administrative, technical, or material support: All authors.

    Supervision: Close, McAuley.

    Conflict of Interest Disclosures: None reported.

    Additional Contributions: We thank LCDR Trevor Thompson, PharmD, BCPS, Whiteriver Service Unit, for support in data collection and aggregation. LCDR Thompson did not receive any compensation.

    References
    1.
    Gottlieb  RL, Nirula  A, Chen  P,  et al.  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. 2021;325(7):632-644. doi:10.1001/jama.2021.0202 PubMedGoogle ScholarCrossref
    2.
    Weinreich  DM, Sivapalasingam  S, Norton  T,  et al; Trial Investigators.  REGN-COV2, a neutralizing antibody cocktail, in outpatients with COVID-19.   N Engl J Med. 2021;384(3):238-251. doi:10.1056/NEJMoa2035002 PubMedGoogle ScholarCrossref
    3.
    US Food and Drug Administration. Fact sheet for health care providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. November 9, 2020. Updated May 14, 2021. Accessed January 29, 2021. https://www.fda.gov/media/145802/download
    4.
    US Food and Drug Administration. Fact sheet for health care providers: emergency use authorization (EUA) of REGEN-COV (casirivimab and imdevimab). November 21, 2020. Updated July 30, 2021. Accessed January 29, 2021. https://www.fda.gov/media/145611/download
    5.
    Cheek  JE, Holman  RC, Redd  JT, Haberling  D, Hennessy  TW.  Infectious disease mortality among American Indians and Alaska Natives, 1999-2009.   Am J Public Health. 2014;104(suppl 3):S446-S452. doi:10.2105/AJPH.2013.301721 PubMedGoogle ScholarCrossref
    6.
    Arrazola  J, Masiello  MM, Joshi  S,  et al.  COVID-19 mortality among American Indian and Alaska Native persons—14 states, January-June 2020.   MMWR Morb Mortal Wkly Rep. 2020;69(49):1853-1856. doi:10.15585/mmwr.mm6949a3 PubMedGoogle ScholarCrossref
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