Evidence map›Paper›PMID 39362933›Full record

Trial reportScientific reports2024

Pharmacodynamic, prognostic, and predictive biomarkers in severe and critical COVID-19 patients treated with sirukumab.

Kim Thys, Matthew J Loza, Linghua Lynn, Katleen Callewaert, Lisa Varma, Marjolein Crabbe, Liesbeth Van Wesenbeeck, Erika Van Landuyt, Sandra De Meyer, Jeroen Aerssens and 1 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04380961 (Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease), which is not on this 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.

NCT04380961 phase2completednot on this map

Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease

TypeinterventionalSponsorJanssen Pharmaceutica N.V., BelgiumRan2020 to 2021Enrolled212ConditionsCritical Confirmed Coronavirus Disease (COVID)-19ArmsSirukumab, Placebo, Standard of Care (SOC)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

11 authors.

Kim Thys *Janssen Pharmaceutica NV, Beerse, Belgium.
Matthew J Loza *Janssen Research & Development, LLC, PA, Spring House, USA. mloza@its.jnj.com.
Linghua LynnIQVIA RDS, Solna, Sweden.
Katleen CallewaertJanssen Pharmaceutica NV, Beerse, Belgium.
Lisa VarmaJanssen Research & Development, LLC, PA, Spring House, USA.
Marjolein CrabbeJanssen Pharmaceutica NV, Beerse, Belgium.
Liesbeth Van WesenbeeckJanssen Pharmaceutica NV, Beerse, Belgium.
Erika Van LanduytJanssen Pharmaceutica NV, Beerse, Belgium.
Sandra De MeyerJanssen Pharmaceutica NV, Beerse, Belgium.
Jeroen AerssensJanssen Pharmaceutica NV, Beerse, Belgium.
Inge VerbruggeJanssen Pharmaceutica NV, Beerse, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We examined candidate biomarkers for efficacy outcomes in hospitalized COVID-19 patients who were treated with sirukumab, an IL-6 neutralizing antibody, in a randomized, double-blind, placebo-controlled, phase 2 trial. Between May 2020 and March 2021, 209 patients were randomized (sirukumab, n = 139; placebo, n = 70); 112 had critical COVID-19. Serum biomarkers were evaluated for the pharmacodynamic effect of sirukumab and for their potential prognostic and predictive effect on time to sustained clinical improvement up to Day 28, clinical improvement at Day 28, and mortality at Day 28. The absence of detectable IL-4 increase and smaller increases in CCL13 post-baseline were most significantly associated with better response to sirukumab (versus placebo) treatment for all clinical efficacy outcomes tested, especially in patients with critical COVID-19. These data suggest that patients with critical COVID-19 without detectable sirukumab-induced IL-4 levels are more likely to benefit from sirukumab treatment. ClinicalTrials.gov Identifier: NCT04380961.

Indexed as

Antibodies, Monoclonal, HumanizedBiomarkersCOVID-19COVID-19 Drug TreatmentAdultAgedAntibodies, NeutralizingDouble-Blind MethodFemaleHumansInterleukin-4Interleukin-6MaleMiddle AgedPrognosisSeverity of Illness IndexAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingBiomarkersInterleukin-4Interleukin-6sirukumabBiomarkersCOVID-19IL-4IL-6Inflammation

Identifiers

PMID39362933
PMCPMC11452205

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.