Evidence map›Paper›PMID 35959207›Full record

ArticleOpen forum infectious diseases2022

Safety and Efficacy of Dupilumab for the Treatment of Hospitalized Patients With Moderate to Severe Coronavirus Disease 2019: A Phase 2a Trial.

Jennifer Sasson, Alexandra N Donlan, Jennie Z Ma, Heather M Haughey, Rachael Coleman, Uma Nayak, Amy J Mathers, Sylvain Laverdure, Robin Dewar, Patrick E H Jackson and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04920916 (Safety and Efficacy of the Treatment of Hospitalized Patients With COVID 19 Infection With an Inhibitor of IL-4 and IL-13 Signaling), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.7field-weighted citation impact, top 8% 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.

NCT04920916 phase2completednot on this map

Safety and Efficacy of the Treatment of Hospitalized Patients With COVID 19 Infection With an Inhibitor of IL-4 and IL-13 Signaling: A Phase IIa Trial

TypeinterventionalSponsorUniversity of VirginiaRan2021 to 2023Enrolled40ConditionsCOVID-19ArmsDupilumab, Placebo
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
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  6. Review
  7. Article
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  12. Hyaluronan in the pathogenesis of acute and post-acute COVID-19 infection.Matrix biology : journal of the International Society for Matrix Biology · 2023
    Review
  13. Dupilumab Use Is Associated With Protection From Coronavirus Disease 2019 Mortality: A Retrospective Analysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  14. Article
  15. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Jennifer SassonDivision of Infectious Diseases and International Health, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
Alexandra N DonlanDivision of Infectious Diseases and International Health, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
Jennie Z MaDepartment of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Heather M HaugheyDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
Rachael ColemanDivision of Infectious Diseases and International Health, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
Uma NayakCenter for Public Health Genomics and Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Amy J MathersDivision of Infectious Diseases and International Health, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
Sylvain LaverdureLaboratory of Human Retrovirology and Immunoinformatics, Frederick National Laboratory, Frederick, Maryland, USA.
Robin DewarVirus Isolation and Serology Laboratory, Frederick National Laboratory, Frederick, Maryland, USA.
Patrick E H JacksonDivision of Infectious Diseases and International Health, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
Scott K HeysellDivision of Infectious Diseases and International Health, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
Jeffrey M SturekDivision of Pulmonary and Critical Care Medicine, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
William A PetriDivision of Infectious Diseases and International Health, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, USA.
University of Virginia Health System · USUniversity of Virginia · USFrederick National Laboratory for Cancer Research · US

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
The integrated Translational Health Research Institute of Virginia (iTHRIV): Using Data to Improve HealthUL1TR003015 · NCATS · UNIVERSITY OF VIRGINIA · PI BROWN, DONALD E, JOHNSTON, KAREN C. · 2019 to 2023
$20.3M
INTERDISCIPLINARY TRAINING PROGRAM IN IMMUNOLOGYT32AI007496 · NIAID · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Michael G. Brown, Coleen A McNamara · 1995 to 2026
$10.2M
Role of Type 2 Immunity in Innate Protection from C. difficileR01AI124214 · NIAID · UNIVERSITY OF VIRGINIA · PI William A Petri · 2016 to 2026
$5.4M
Institutional Career Development CoreKL2TR003016 · NCATS · UNIVERSITY OF VIRGINIA · PI PAPIN, JASON, WORRALL, BRADFORD B · 2019 to 2023
$3.9M
Kidney Disease and InflammationT32DK072922 · NIDDK · UNIVERSITY OF VIRGINIA · PI OKUSA, MARK DOUGLAS · 2006 to 2020
$2.6M
IGNITE KUH NRSA Training CoreTL1DK132771 · NIDDK · UNIVERSITY OF VIRGINIA · PI PORTILLA, DIDIER · 2021 to 2025
$1.9M
Interdisciplinary Training in Systems & Biomolecular Data ScienceT32GM145443 · NIGMS · UNIVERSITY OF VIRGINIA · PI Kevin A Janes, Jason Papin · 2022 to 2026
$1.5M
Integrated Virginia Research Training Centers in KUH (IGNITE KUH)U2CDK129500 · NIDDK · UNIVERSITY OF VIRGINIA · PI SHARMA, RAHUL · 2021 to 2025
$1.4M
NCATS NIH HHS KL2 TR003016NCATS NIH HHS UL1 TR003015NCI NIH HHS 75N91019D00024NIAID NIH HHS R01 AI124214NIAID NIH HHS T32 AI007496NIDDK NIH HHS T32 DK072922NIDDK NIH HHS TL1 DK132771NIDDK NIH HHS U2C DK129500NIGMS NIH HHS T32 GM145443
6 · The paper itself

Abstract

Background: Based on studies implicating the type 2 cytokine interleukin 13 (IL-13) as a potential contributor to critical coronavirus disease 2019 (COVID-19), this trial was designed as an early phase 2 study to assess dupilumab, a monoclonal antibody that blocks IL-13 and interleukin 4 signaling, for treatment of inpatients with COVID-19. Methods: We conducted a phase 2a randomized, double-blind, placebo-controlled trial (NCT04920916) to assess the safety and efficacy of dupilumab plus standard of care vs placebo plus standard of care in mitigating respiratory failure and death in those hospitalized with COVID-19. Results: Forty eligible subjects were enrolled from June to November of 2021. There was no statistically significant difference in adverse events nor in the primary endpoint of ventilator-free survival at day 28 between study arms. However, for the secondary endpoint of mortality at day 60, there were 2 deaths in the dupilumab group compared with 5 deaths in the placebo group (60-day survival: 89.5% vs 76.2%; adjusted hazard ratio [HR], 0.05 [95% confidence interval {CI}, .004-.72]; Conclusions: Although the primary outcome of day 28 ventilator-free survival was not reached, adverse events were not observed and survival was higher in the dupilumab group by day 60. Clinical Trials Registration: NCT04920916.

Indexed as

COVID-19dupilumabIL-13SARS-CoV-2type 2 immunity

Identifiers

PMID35959207
PMCPMC9361171
OpenAlexW4288096714

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.