Evidence map›Paper›PMID 40124489›Full record

ArticleiScience2025

Tixagevimab/cilgavimab or placebo for COVID-19 in ACTIV-2: Safety, pharmacokinetics and neutralizing and anti-drug antibodies.

Rachel A Bender Ignacio, Kara W Chew, Carlee Moser, Judith S Currier, Joseph J Eron, Arzhang Cyrus Javan, Mark J Giganti, Justin Ritz, Michael Gibbs, Hervé Tchouakam Kouekam and 10 more

Abstract read
In one paragraph

Article in iScience, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

20 authors.

Rachel A Bender IgnacioDivision of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, WA, USA.
Kara W ChewDivision of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
Carlee MoserDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Judith S CurrierDivision of Infectious Diseases, Department of Medicine, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
Joseph J EronDivision of Infectious Diseases, Department of Medicine, University of Carolina School of Medicine, Chapel Hill, NC, USA.
Arzhang Cyrus JavanNational Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD, USA.
Mark J GigantiDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Justin RitzDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Michael GibbsVaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Hervé Tchouakam KouekamVaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Mark T EsserVaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.
Eric S DaarDivision of HIV Medicine, Lundquist Institute, Harbor-UCLA Medical Center, Los Angeles, CA, USA.
Manish ChoudharyDivision of Infectious Diseases, Department of Medicine, Harvard Medical School, Boston, MA, USA.
Rinki DeoDivision of Infectious Diseases, Department of Medicine, Harvard Medical School, Boston, MA, USA.
Courtney V FletcherUNMC Center for Drug Discovery, University of Nebraska Medical Center, Omaha, NE, USA.
Jonathan Z LiDivision of Infectious Diseases, Department of Medicine, Harvard Medical School, Boston, MA, USA.
Michael D HughesDepartment of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.
Davey SmithDivision of Infectious Diseases and Global Public Health, Department of Medicine, University of California San Diego, San Diego, CA, USA.
David Alain WohlDivision of Infectious Diseases, Department of Medicine, University of Carolina School of Medicine, Chapel Hill, NC, USA.
ACTIV-2/A5401 Study Team

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
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
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
Seattle Vaccine Trials UnitUM1AI069481 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Rachel Ann Bender Ignacio, Margaret Juliana McElrath · 2012 to 2026
$24.4M
UCLA AIDS Prevention and Treatment Clinical Trials UnitU01AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI CURRIER, JUDITH S. · 2007 to 2011
$13.9M
NIAID NIH HHS U01 AI069424NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069424NIAID NIH HHS UM1 AI069481
6 · The paper itself

Abstract

Monoclonal antibodies have potential as rapidly developable agents for treatment and prevention of emerging viruses. The ACTIV-2 trial randomized persons with mild-moderate COVID-19 to the monoclonal antibody combination tixagevimab/cilgavimab via intramuscular injection (600 mg IM) or infusion (300 mg IV) versus placebo. We present final safety and laboratory outcomes; primary outcomes were previously reported. The analyzed IM group included 214 participants, and the IV group, 106 participants. Adverse events were not different between treatment and placebo. The half-life of both components was >90 days for IM or 75 days for IV. New anti-drug antibodies were about 3 times more likely in active vs. placebo recipients. SARS-CoV-2 neutralizing antibodies increased 157-fold at 7 days and 127-fold at 1 month (IM-treated) but were less robust in IV participants. These data can inform future development of monoclonal antibodies against SARS-CoV-2 and other viruses, even if this intervention is of low utility for contemporary SARS-CoV-2 variants.

Indexed as

Health sciencesImmunologyMedical specialtyMedicine

Identifiers

PMID40124489
PMCPMC11927737

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.