Evidence map›Paper›PMID 35995785›Full record

Trial reportNature communications2022

Antiviral and clinical activity of bamlanivimab in a randomized trial of non-hospitalized adults with COVID-19.

Kara W Chew, Carlee Moser, Eric S Daar, David A Wohl, Jonathan Z Li, Robert W Coombs, Justin Ritz, Mark Giganti, Arzhang Cyrus Javan, Yijia Li and 16 more

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04518410 (Adaptive Platform Treatment Trial for Outpatients With COVID-19), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT04518410 phase2 / phase3completednot on this map

Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2020 to 2023Enrolled4,044ConditionsCoronavirus, Covid19Armsbamlanivimab 7000mg, BRII-196+BRII-198, AZD7442 (IV), AZD7442 (IM), SNG001
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Immune Status and SARS-CoV-2 Viral Dynamics.The Journal of infectious diseases · 2023
    Trial
  8. Variant-Specific Viral Kinetics in Acute COVID-19.The Journal of infectious diseases · 2023
    Trial
  9. Long COVID After Bamlanivimab Treatment.The Journal of infectious diseases · 2023
    Trial
  10. Trial
  11. Trial
  12. Observational
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Review: The Landscape of Antiviral Therapy for COVID-19 in the Era of Widespread Population Immunity and Omicron-Lineage Viruses.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 13 institutions in 1 country.

Kara W ChewDepartment of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA. kchew@mednet.ucla.edu.ORCID http://orcid.org/0000-0003-4865-4348
Carlee MoserHarvard T.H. Chan School of Public Health, Boston, MA, USA.ORCID http://orcid.org/0000-0001-5601-9112
Eric S DaarLundquist Institute at Harbor-UCLA Medical Center, Torrance, CA, USA.
David A WohlDepartment of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.ORCID http://orcid.org/0000-0002-7764-0212
Jonathan Z LiDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0001-9914-9662
Robert W CoombsDepartment of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.ORCID http://orcid.org/0000-0003-2709-0512
Justin RitzHarvard T.H. Chan School of Public Health, Boston, MA, USA.ORCID http://orcid.org/0000-0001-6307-4849
Mark GigantiHarvard T.H. Chan School of Public Health, Boston, MA, USA.
Arzhang Cyrus JavanNational Institutes of Health, Bethesda, MD, USA.
Yijia LiDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Manish C ChoudharyDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Rinki DeoDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Carlos MalvestuttoOhio State University Wexner Medical Center, Columbus, OH, USA.
Paul KlekotkaEli Lilly and Company, San Diego, CA, USA.
Karen PriceEli Lilly and Company, San Diego, CA, USA.
Ajay NirulaEli Lilly and Company, San Diego, CA, USA.
William FischerDepartment of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.
Veenu BalaUNMC Center for Drug Discovery, University of Nebraska Medical Center, Omaha, NE, USA.
Ruy M RibeiroTheoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.ORCID http://orcid.org/0000-0002-3988-8241
Alan S PerelsonTheoretical Biology and Biophysics Group, Los Alamos National Laboratory, Los Alamos, NM, USA.ORCID http://orcid.org/0000-0002-2455-0002
Courtney V FletcherUNMC Center for Drug Discovery, University of Nebraska Medical Center, Omaha, NE, USA.ORCID http://orcid.org/0000-0002-3703-7849
Joseph J EronDepartment of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA.ORCID http://orcid.org/0000-0002-4938-0644
Judith S CurrierDepartment of Medicine, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, CA, USA.ORCID http://orcid.org/0000-0003-4279-4737
ACTIV-2/A5401 Study Team
Michael D HughesHarvard T.H. Chan School of Public Health, Boston, MA, USA.
Davey M SmithDepartment of Medicine, University of California, San Diego, La Jolla, CA, USA.ORCID http://orcid.org/0000-0003-3603-1733
Harvard University · USBrigham and Women's Hospital · USEli Lilly (United States) · USUniversity of North Carolina at Chapel Hill · USLos Alamos National Laboratory · USUniversity of California, Los Angeles · USNational Institutes of Health · USThe Ohio State University Wexner Medical Center · USTherapeutics Clinical Research · USUCLA Medical Center · USUniversity of California San Diego · USUniversity of Nebraska Medical Center · USUniversity of Washington · US

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
University of Pittsburgh Clinical Trials UnitUM1AI069494 · NIAID · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SUSAN L KOLETAR, John W Mellors · 2012 to 2026
$38.0M
Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplicationUM1AI069463 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI REES, HELEN, SANNE, IAN MATTHIAS · 2012 to 2025
$31.8M
Modeling Viral and T Lymphocyte DynamicsR01OD011095 · OD · TRIAD NATIONAL SECURITY, LLC · PI PERELSON, ALAN S · 2012 to 2024
$5.0M
Immune System Modeling/HIVR01AI028433 · NIAID · UNIVERSITY OF CALIF-LOS ALAMOS NAT LAB · PI PERELSON, ALAN S · 1990 to 2021
$3.7M
NIAID NIH HHS R01 AI028433NIAID NIH HHS U01 AI068636NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069432NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069494NIAID NIH HHS UM1 AI106701NIH HHS R01 OD011095
6 · The paper itself

Abstract

Anti-SARS-CoV-2 monoclonal antibodies are mainstay COVID-19 therapeutics. Safety, antiviral, and clinical efficacy of bamlanivimab were evaluated in the randomized controlled trial ACTIV-2/A5401. Non-hospitalized adults were randomized 1:1 within 10 days of COVID-19 symptoms to bamlanivimab or blinded-placebo in two dose-cohorts (7000 mg, n = 94; 700 mg, n = 223). No differences in bamlanivimab vs placebo were observed in the primary outcomes: proportion with undetectable nasopharyngeal SARS-CoV-2 RNA at days 3, 7, 14, 21, and 28 (risk ratio = 0.82-1.05 for 7000 mg [p(overall) = 0.88] and 0.81-1.21 for 700 mg [p(overall) = 0.49]), time to symptom improvement (median 21 vs 18.5 days [p = 0.97], 7000 mg; 24 vs 20.5 days [p = 0.08], 700 mg), or grade 3+ adverse events. However, bamlanivimab was associated with lower day 3 nasopharyngeal viral levels and faster reductions in inflammatory markers and viral decay by modeling. This study provides evidence of faster reductions in nasopharyngeal SARS-CoV-2 RNA levels but not shorter symptom durations in non-hospitalized adults with early variants of SARS-CoV-2.

Indexed as

COVID-19 Drug TreatmentAdultAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntibodies, ViralAntiviral AgentsHumansRNA, ViralSARS-CoV-2Antibodies, Monoclonal, HumanizedAntibodies, NeutralizingAntibodies, ViralAntiviral AgentsbamlanivimabRNA, Viral

Identifiers

PMID35995785
PMCPMC9395368
OpenAlexW4292979136

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.