Evidence map›Paper›PMID 37948759›Full record

Trial reportThe Journal of infectious diseases2024

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

Tomas O Jensen, Greg A Grandits, Mamta K Jain, Thomas A Murray, Birgit Grund, Kathryn Shaw-Saliba, Michael A Matthay, Mahsa Abassi, Magdalena Ardelt, Jason V Baker and 24 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04501978 (A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04501978 phase3completednot on this map

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2020 to 2023Enrolled2,753ConditionsCovid19ArmsLY3819253, Placebo, Remdesivir, VIR-7831, BRII-196/BRII-198
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Machine learning in AIRR diagnostics: Advances and applications.Immunoinformatics (Amsterdam, Netherlands) · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors at 19 institutions in 6 countries.

Tomas O JensenCentre of Excellence for Health, Immunity, and Infections, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0003-0398-4431
Greg A GranditsDivision of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA.
Mamta K JainSouthwestern Medical Center, University of Texas, Dallas, Texas  USA.ORCID 0000-0003-2292-6544
Thomas A MurrayDivision of Biostatistics, University of Minnesota, Minneapolis, Minnesota, USA.
Birgit GrundSchool of Statistics, University of Minnesota, Minneapolis, Minnesota, USA.
Kathryn Shaw-SalibaNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Michael A MatthayDivision of Pulmonary and Critical Care Medicine, University of California SanFrancisco, San Francisco, California, USA.
Mahsa AbassiDivision of Infectious Diseases and International Medicine, University of Minnesota, Minneapolis, Minnesota, USA.ORCID 0000-0001-9601-3006
Magdalena ArdeltDivision of Pulmonary and Critical Care Medicine, University of California SanFrancisco, San Francisco, California, USA.
Jason V BakerDivision of Infectious Diseases and International Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Peter ChenWomen's Guild Lung Institute, Department of medicine and Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Robin L DewarFrederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Anna L GoodmanMedical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Timothy J HatlenLundquist Institute, Harbor-University of California Los Angeles Medical Center, Torrance, California, USA.
Helene C HighbargerFrederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Mark HolodniyDepartment of Medicine, Infectious Diseases, Stanford University, Stanford, California, USA.ORCID 0000-0002-6655-7982
Perrine LallemandFrederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Sylvain LaverdureLaboratory of Human Retrovirology and Immunoinformatics, Frederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Bradley G LeshnowerDivision of Cardiothoracic Surgery, Emory School of Medicine, Atlanta, Georgia, USA.
David LooneyDivision of Infectious Diseases and Global Public Health, University of California San Diego, San Diego, California, USA.
Charalampos D MoschopoulosSchool of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Henry MugerwaJoint Clinical Research Centre, Kampala, Uganda.
Daniel D MurrayCentre of Excellence for Health, Immunity, and Infections, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Eleftherios MylonakisDepartment of Medicine, Houston Methodist Hospital, Houston, Texas, USA.ORCID 0000-0002-4624-0777
Stephanie Nagy-AgrenSalem Veterans Affairs Medical Center, Virginia, USA.
M Tauseef RehmanFrederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Adam RupertFrederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Randy A StevensFrederick National Laboratory for Cancer Research, Frederick, Maryland, USA.
Stuart TurvilleThe Kirby Institute, University of New South Wales, Sydney, Australia.
Amy WeintrobInfectious Diseases Section, Washington DC Veterans Affairs Medical Center, Washington, District of Columbia, USA.
Katherine WickDepartment of Internal Medicine, University of California Davis, Davis, California, USA.
Jens LundgrenCentre of Excellence for Health, Immunity, and Infections, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0001-8901-7850
Emily R KoDivision of General Internal Medicine, Department of Medicine, Duke University Health System, Durham, North Carolina, USA.
ACTIV-3/TICO Study Group
University of Copenhagen · DKDuke University Health System · USUniversity of Minnesota · USFrederick National Laboratory for Cancer Research · USUniversity of California, San Francisco · USUniversity of California System · USUniversity of California, Davis · USSouthwestern Medical CenterCedars-Sinai Medical Center · USJoint Clinical Research Centre · UGUCLA Medical Center · USUNSW Sydney · AUVA Palo Alto Health Care System · USNational and Kapodistrian University of Athens · GRNational Health Service · GBNational Institutes of Health · USCarilion Clinic · USMethodist Hospital · USEmory Healthcare · US

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating CenterOT2HL156812 · NHLBI · RESEARCH TRIANGLE INSTITUTE · PI NOLEN, TRACY L, THOMAS, SONIA M · 2020 to 2024
$1270.7M
REVISED CAROL ACT IIU01HL088942 · NHLBI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI GELIJNS, ANNE CHRISTINE, MOSKOWITZ, ALAN J · 2007 to 2025
$122.6M
Extended follow-up of randomized participants in the INSIGHT START trialU01AI136780 · NIAID · UNIVERSITY OF MINNESOTA · PI GRUND, BIRGIT, REILLY, CAVAN S. · 2019 to 2024
$18.0M
NCI NIH HHSNHLBI NIH HHS OT2 HL156812NHLBI NIH HHS U01 HL088942NIAID NIH HHS U01 AI136780NIH HHS 75N91019D00024
6 · The paper itself

Abstract

backgroundNeutralizing 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.

methodsParticipants 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.

resultsAnalysis 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.

conclusionsOur 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. CLINICAL TRIALS REGISTRATION: NCT04501978.

Indexed as

COVID-19Antibodies, MonoclonalAntibodies, NeutralizingBiomarkersHumansSARS-CoV-2Antibodies, MonoclonalAntibodies, NeutralizingBiomarkersanti-nucleocapsid antibodyCOVID-19inflammatory biomarkersneutralizing monoclonal antibodyplasma nucleocapsid antigen

Identifiers

PMID37948759
PMCPMC10938202
OpenAlexW4388557171

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.