Evidence map›Paper›PMID 39731852›Full record

Trial reportEBioMedicine2025

Safety of baricitinib in vaccinated patients with severe and critical COVID-19 sub study of the randomised Bari-SolidAct trial.

Hans-Kittil Viermyr, Kristian Tonby, Erica Ponzi, Sophie Trouillet-Assant, Julien Poissy, José R Arribas, Virginie Dyon-Tafani, Maude Bouscambert-Duchamp, Lambert Assoumou, Bente Halvorsen and 39 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in EBioMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. The oxidative stress paradigm in arbovirus infections: mechanisms and therapeutic insights.Redox report : communications in free radical research · 2026
    Review
  2. Article
  3. 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

49 authors.

Hans-Kittil ViermyrResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Section for Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet, Oslo, Norway.
Kristian TonbyFaculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Infectious Diseases, Oslo University Hospital Ullevål, Oslo, Norway.
Erica PonziDepartment of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.
Sophie Trouillet-AssantCentre International de Recherche en Infectiologie (CIRI), Université Claude Bernard Lyon 1, Inserm, U1111, CNRS, UMR5308, ENS Lyon, Lyon, France; Joint Research Unit Hospices Civils de Lyon-bioMerieux S.A., Hôpital Lyon Sud, Pierre-Bénite, France.
Julien PoissyUniversité Lille, Inserm U1285, CHU Lille, Pôle de Médecine Intensive-Réanimatin, CNRS, UMR 8576, France; Université Lille, Unité de Glycobiologie Structurale et Fonctionnelle (UGSF), F-59000, Lille, France.
José R ArribasInfectious Diseases Unit, Internal Medicine Department, La Paz University Hospital, IdiPAZ, Madrid, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Madrid, Spain.
Virginie Dyon-TafaniCentre International de Recherche en Infectiologie (CIRI), Université Claude Bernard Lyon 1, Inserm, U1111, CNRS, UMR5308, ENS Lyon, Lyon, France.
Maude Bouscambert-DuchampHospices Civils de Lyon, Laboratoire de Virologie, Institut des Agents Infectieux de Lyon, Centre National de Référence des Virus Respiratoires France Sud, F-69317, Lyon, France; Université Claude Bernard Lyon 1, Virpath, CIRI, INSERM U1111, CNRS UMR5308, ENS Lyon, F-69372, Lyon, France.
Lambert AssoumouSorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique (IPLESP), Paris, France.
Bente HalvorsenResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Nuriye Basdag TekinResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Alpha DialloANRS, Maladies Infectieuses Emergentes, F-75015, Paris, France; Institut National de la Santé et de la Recherche Médicale, INSERM, F-75013, Paris, France.
Lucie De GastinesANRS, Maladies Infectieuses Emergentes, F-75015, Paris, France; Institut National de la Santé et de la Recherche Médicale, INSERM, F-75013, Paris, France.
Ludvig A MuntheDepartment of Immunology, Oslo University Hospital, Oslo, Norway; KG Jebsen Centre for B Cell Malignancies, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Precision Immunotherapy Alliance, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Sarah Louise MurphyResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Thor UelandResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Thrombosis Research Center (TREC), Division of Internal Medicine, University Hospital of North Norway, Tromsø, Norway.
Annika E MichelsenResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Fridtjof Lund-JohansenDepartment of Immunology, Oslo University Hospital, Oslo, Norway; Precision Immunotherapy Alliance, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Pål AukrustResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Joy MootienIntensive Care Unit, Antibiotic Stewardship Team, Groupe Hospitalier Région Mulhouse et Sud Alsace, Mulhouse, France.
Benjamin DervieuxInfectious Diseases Unit, Groupe Hospitalier Région Mulhouse et Sud Alsace, Mulhouse, France.
Yoann ZerbibIntensive Care Department, Amiens-Picardie University Hospital, Amiens, France.
Jean-Christophe RichardMedical Intensive Care Unit, Hospices Civils de Lyon, Croix-Rousse Hospital - Université Lyon 1, Lyon, France; CREATIS INSERM 1044 CNRS 5220, Villeurbanne, France.
Renaud PrévelCHU Bordeaux, Medical Intensive Care Unit, Bordeaux, France; Univ Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, Inserm UMR 1045, Bordeaux, France.
Denis MalvyDepartment of Infectious and Tropical Diseases, University Hospital, UMR 1219 Inserm/EMR 271 IRD, University of Bordeaux, Bordeaux, France.
Jean-François TimsitAP-HP, Bichat Hospital, Medical and Infectious Diseases ICU (MI2), F-75018, Paris, France; Université Paris-Cité, INSERM, F-75018, Paris, France; OUCTOME REA Research Network, France.
Nathan Peiffer-SmadjaUniversité Paris Cité, Inserm, IAME, Paris, 75018, France; Service de Maladies Infectieuses et Tropicales, Hôpital Bichat Claude Bernard, AP-HP, Paris, 75018, France.
Damien RouxUniversité Paris Cité, AP-HP, Hôpital Louis Mourier, DMU ESPRIT, Service de Médecine Intensive Réanimation, Colombes, France.
Lionel PirothInfectious Diseases Department, University Hospital, Dijon, France; INSERM CIC 1432, University of Burgundy, Dijon, France.
Hafid Ait-OufellaService de Médecine Intensive-Réanimation, Hôpital Saint-Antoine, AP-HP, Sorbonne Université, Paris, F-75012, France.
Cesar VieiraCentro Hospitalar Universitário de Lisboa Central, Hospital Curry Cabral, Department of Intensive Care Medicine - Lisbon, Portugal.
Olav DalgardDepartment of Infectious Diseases, Oslo University Hospital Ullevål, Oslo, Norway; Department of Infectious Diseases, Akershus University Hospital, Norway.
Lars HeggelundDepartment of Internal Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Norway; Department of Clinical Science, Bergen Integrated Diagnostic Stewardship Cluster, Faculty of Medicine, University of Bergen, Bergen, Norway.
Karl Erik MüllerDepartment of Internal Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Norway; Department of Clinical Science, Bergen Integrated Diagnostic Stewardship Cluster, Faculty of Medicine, University of Bergen, Bergen, Norway.
Jannicke Horjen MøllerDepartment of Intensive Care Medicine, Stavanger University Hospital, Stavanger, Norway.
Anders Benjamin KildalDepartment of Anesthesiology and Intensive Care, University Hospital of North Norway, Tromsø, Norway; Faculty of Health Sciences, UIT The Arctic University of Norway, Norway.
Vegard SkogenDepartment of Infectious Diseases, University Hospital of North Norway, Tromsø, Norway; Faculty of Health Sciences, UIT The Arctic University of Norway, Norway.
Saad AballiDepartment of Infectious Diseases, Østfold Hospital Kalnes, Grålum, Norway.
Jonas Daniel Sjøberg ØgaardResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Anne Ma Dyrhol-RiiseFaculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Infectious Diseases, Oslo University Hospital Ullevål, Oslo, Norway.
Anders TveitaResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Section for Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet, Oslo, Norway; Department of Internal Medicine, Bærum Hospital, Vestre Viken Hospital Trust, 1346, Gjettum, Norway.
Amin AlirezaylavasaniDepartment of Immunology, Oslo University Hospital, Oslo, Norway.
Dominique CostagliolaSorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique (IPLESP), Paris, France.
Yazdan YazdanpanahInfectious and Tropical Diseases Department, Bichat - Claude Bernard Hospital, AP-HP Nord-Université Paris Cité, Paris, France; IAME INSERM UMR 1137, Université Paris Cité, Paris, France; ANRS, Maladies Infectieuses Emergentes, F-75015, Paris, France; Institut National de la Santé et de la Recherche Médicale, INSERM, F-75013, Paris, France.
Inge Christoffer OlsenDepartment of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.
Tuva Børresdatter DahlResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Hassen KaredDepartment of Immunology, Oslo University Hospital, Oslo, Norway; KG Jebsen Centre for B Cell Malignancies, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Precision Immunotherapy Alliance, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.
Aleksander Rygh HoltenDepartment of Infectious Diseases, Oslo University Hospital Ullevål, Oslo, Norway; Department of Acute Medicine, Oslo University Hospital, Oslo, Norway.
Marius TrøseidResearch Institute of Internal Medicine, Oslo University Hospital Rikshospitalet, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Section for Clinical Immunology and Infectious Diseases, Oslo University Hospital Rikshospitalet, Oslo, Norway. Electronic address: marius.troseid@medisin.uio.no.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Bari-SolidAct randomized controlled trial compared baricitinib with placebo in patients with severe COVID-19. A post hoc analysis revealed a higher incidence of serious adverse events (SAEs) among SARS-CoV-2-vaccinated participants who had received baricitinib. This sub-study aimed to investigate whether vaccination influences the safety profile of baricitinib in patients with severe COVID-19.

methodsBiobanked samples from 146 participants (55 vaccinated vs. 91 unvaccinated) were analysed longitudinally for inflammation markers, humoral responses, tissue viral loads, and plasma viral antigens on days 1, 3, and 8. High-dimensional analyses, including RNA sequencing and flow cytometry, were performed on available samples. Mediation analyses were used to assess relationships between SAEs, baseline-adjusted biomarkers, and treatment-vaccination status.

findingsVaccinated participants were older, more frequently hospitalized, had more comorbidities, and exhibited higher nasopharyngeal viral loads. Baricitinib treatment did not affect antibody responses or viral clearance, but reduced markers of T-cell and monocyte activation compared to placebo (sCD25, sCD14, sCD163, sTIM-3). Age, baseline levels of plasma viral antigen, and several inflammatory markers, as well as IL-2, IL-6, Neopterin, CXCL16, sCD14, and suPAR on day 8 were associated with the occurrence of SAEs. However, mediation analyses of markers linked to SAEs, baricitinib treatment, or vaccination status did not reveal statistically significant interactions between vaccination status and SAEs.

interpretationThis sub-study did not identify any virus- or host-related biomarkers significantly associated with the interaction between SARS-CoV-2 vaccination status and the safety of baricitinib. However, caution should be exercised due to the moderate sample size.

fundingEU Horizon 2020 (grant number 101015736).

Indexed as

AzetidinesCOVID-19COVID-19 Drug TreatmentCOVID-19 VaccinesPyrazolesSARS-CoV-2SulfonamidesAdultAgedBiomarkersFemaleHumansMaleMiddle AgedPurinesVaccinationAzetidinesbaricitinibBiomarkersCOVID-19 VaccinesPurinesPyrazolesSulfonamidesBaricitinibCOVID-19ImmunomodulationInflammationJAK/STAT-inhibitorSARS-CoV-2 vaccinationSerious adverse events

Identifiers

PMID39731852
PMCPMC11743795

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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.