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Effect of Neutralizing Monoclonal Antibody Treatment on Early Trajectories of Virologic and Immunologic Biomarkers in Patients Hospitalized With COVID-19

  1. Author:
    Jensen, Tomas O [ORCID]
    Grandits, Greg A
    Jain, Mamta K [ORCID]
    Murray, Thomas A
    Grund, Birgit
    Shaw-Saliba, Kathryn
    Matthay, Michael A
    Abassi, Mahsa [ORCID]
    Ardelt, Magdalena
    Baker, Jason V
    Chen, Peter
    Dewar, Robin L
    Goodman, Anna L
    Hatlen, Timothy J
    Highbarger, Helene C
    Holodniy, Mark [ORCID]
    Lallemand, Perrine
    Laverdure,Sylvain
    Leshnower, Bradley G
    Looney, David
    Moschopoulos, Charalampos D
    Mugerwa, Henry
    Murray, Daniel D
    Mylonakis, Eleftherios [ORCID]
    Nagy-Agren, Stephanie
    Rehman, M Tauseef
    Rupert, Adam
    Stevens, Randy A
    Turville, Stuart
    Weintrob, Amy
    Wick, Katherine
    Lundgren, Jens [ORCID]
    Ko, Emily R

  2. Author Address

    Centre of Excellence for Health, Immunity, and Infections, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark., Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA., Southwestern Medical Center, University of Texas, Dallas, Texas 160;USA., School of Statistics, University of Minnesota, Minneapolis, Minnesota, USA., National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA., Division of Pulmonary and Critical Care Medicine, University of California SanFrancisco, San Francisco, California, USA., Division of Infectious Diseases and International Medicine, University of Minnesota, Minneapolis, Minnesota, USA., Division of Infectious Diseases, Hennepin Healthcare, Minneapolis, Minnesota, USA., Women 39;s Guild Lung Institute, Department of medicine and Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California, USA., Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA., Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom., Department of Infectious Diseases, Guy 39;s and St Thomas 39; National Health Service Foundation Trust, London, United Kingdom., Lundquist Institute, Harbor-University of California Los Angeles Medical Center, Torrance, California, USA., Department of Medicine, Infectious Diseases, Stanford University, Stanford, California, USA., Veterans Affairs Palo Alto Health Care System, Palo Alto, California, USA., Laboratory of Human Retrovirology and Immunoinformatics, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA., Division of Cardiothoracic Surgery, Emory School of Medicine, Atlanta, Georgia, USA., Division of Infectious Diseases and Global Public Health, University of California San Diego, San Diego, California, USA., School of Medicine, National and Kapodistrian University of Athens, Athens, Greece., Joint Clinical Research Centre, Kampala, Uganda., Department of Medicine, Houston Methodist Hospital, Houston, Texas, USA., Salem Veterans Affairs Medical Center, Virginia, USA., Virginia Tech Carilion School of Medicine, Virginia, USA., The Kirby Institute, University of New South Wales, Sydney, Australia., Infectious Diseases Section, Washington DC Veterans Affairs Medical Center, Washington, District of Columbia, USA., Department of Internal Medicine, University of California Davis, Davis, California, USA., Division of General Internal Medicine, Department of Medicine, Duke University Health System, Durham, North Carolina, USA.,
    1. Year: 2023
    2. Date: Nov 09
    3. Epub Date: 2023 11 09
  2. Journal: The Journal of Infectious Diseases
  4. Type of Article: Article
  5. Article Number: jiad446
  1. Abstract:

    Neutralizing monoclonal antibodies (nmAbs) failed to show clear benefit for hospitalized patients with coronavirus disease 2019 (COVID-19). Dynamics of virologic and immunologic biomarkers remain poorly understood. Participants enrolled in the Therapeutics for Inpatients with COVID-19 trials were randomized to nmAb versus placebo. Longitudinal differences between treatment and placebo groups in levels of plasma nucleocapsid antigen (N-Ag), anti-nucleocapsid antibody, C-reactive protein, interleukin-6, and d-dimer at enrollment, day 1, 3, and 5 were estimated using linear mixed models. A 7-point pulmonary ordinal scale assessed at day 5 was compared using proportional odds models. Analysis included 2149 participants enrolled between August 2020 and September 2021. Treatment resulted in 20% lower levels of plasma N-Ag compared with placebo (95% confidence interval, 12%-27%; P < .001), and a steeper rate of decline through the first 5 days (P < .001). The treatment difference did not vary between subgroups, and no difference was observed in trajectories of other biomarkers or the day 5 pulmonary ordinal scale. Our study suggests that nmAb has an antiviral effect assessed by plasma N-Ag among hospitalized patients with COVID-19, with no blunting of the endogenous anti-nucleocapsid antibody response. No effect on systemic inflammation or day 5 clinical status was observed. NCT04501978. © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

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External Sources

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  2. DOI: 10.1093/infdis/jiad446
  3. PMID: 37948759
  4. PII : 7394033

Library Notes

  1. Fiscal Year: FY2023-2024
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