Evidence map›Paper›PMID 36229048›Full record

Trial reportThe European respiratory journal2023

A randomised trial of anti-GM-CSF otilimab in severe COVID-19 pneumonia (OSCAR).

Jatin Patel, Damon Bass, Albertus Beishuizen, Xavier Bocca Ruiz, Hatem Boughanmi, Anthony Cahn, Hugo Colombo, Gerard J Criner, Katherine Davy, Javier de-Miguel-Díez and 35 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The European respiratory journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04376684 (A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
3.7field-weighted citation impact, top 5% 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.

NCT04376684 phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2020 to 2021Enrolled1,156ConditionsSevere Acute Respiratory SyndromeArmsOtilimab, Placebo 1, Placebo 2, Standard of care
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 42 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Article
  9. Increased levels of GM-CSF and CXCL10 and low CD8Immunity & ageing : I & A · 2024
    Article
  10. Article
  11. COVID-19 Pneumonia and Cytokine Storm Syndrome.Advances in experimental medicine and biology · 2024
    Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

45 authors at 20 institutions in 11 countries.

Jatin PatelGSK Medicines Research Centre, Stevenage, UK.
Damon BassGSK, Research Triangle Park, NC, USA.
Albertus BeishuizenIntensive Care Center, Medisch Spectrum Twente, Enschede, The Netherlands.
Xavier Bocca RuizServicio de Neumonologia, Clinica Monte Grande, Buenos Aires, Argentina.
Hatem BoughanmiService de Réanimation, CH Valenciennes - Hôpital Jean Bernard, Valenciennes Cedex, France.
Anthony CahnGSK Medicines Research Centre, Stevenage, UK.
Hugo ColomboClinica Privada Colombo, Córdoba, Argentina.
Gerard J CrinerDept of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University Hospital, Philadelphia, PA, USA.
Katherine DavyGSK Medicines Research Centre, Stevenage, UK.
Javier de-Miguel-DíezRespiratory Dept, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Pablo A DoreskiClinica Independencia de Munro, Buenos Aires, Argentina.
Sofia FernandesGSK Medicines Research Centre, Stevenage, UK.
Bruno FrançoisService Réanimation Polyvalente and Inserm CIC1435 & UMR1092, CHU Limoges, Limoges Cedex, France.
Anubha GuptaGSK Medicines Research Centre, Stevenage, UK.
Kate HanrottGSK Medicines Research Centre, Stevenage, UK.ORCID 0000-0002-9629-8491
Timothy HatlenHarbor-UCLA Medical Center, Torrance, CA, USA.
Dave InmanGSK Medicines Research Centre, Stevenage, UK.
John D IsaacsNewcastle University and Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Emily JarvisGSK Medicines Research Centre, Stevenage, UK.
Natalia KostinaVoronezh Regional Clinical Hospital, Voronezh, Russia.ORCID 0000-0002-5128-5005
Tatiana KropotinaBUZ Regional Clinical Hospital, Omsk, Russia.
Jean-Claude LacheradeService de Médecine Intensive Réanimation, CHD Vendée - Site De La Roche-sur-Yon, La Roche-Sur-Yon, France.
Divya LakshminarayananGSK, Collegeville, PA, USA.
Pedro Martinez-AyalaHospital Civil Fray Antonio Alcalde, Guadalajara, Mexico.
Charlene McEvoyRegions Hospital, St. Paul, MN, USA.
Ferhat MezianiDept of Intensive Care, Service de Médecine Intensive - Réanimation, Nouvel Hôpital Civil, Hôpital Universitaire de Strasbourg, Strasbourg, France.
Mehran MonchiGroupe Hospitalier Sud Ile-de-France, Melun, France.
Sumanta MukherjeeGSK, Collegeville, PA, USA.
Rosana Muñoz-BermúdezHospital del Mar-IMIM, Barcelona, Spain.
Jessica NeisenGSK Medicines Research Centre, Stevenage, UK.
Ciara O'SheaGSK, Dublin, Ireland.
Gaëtan PlantefeveService de Réanimation Polyvalente, CH Victor Dupouy, Argenteuil, France.ORCID 0000-0003-3070-7368
Lorrie SchifanoGSK, Research Triangle Park, NC, USA.
Lee E SchwabHoly Cross Health, Silver Spring, MD, USA.
Zainab ShahidLevine Cancer Institute, Atrium Health, Charlotte, NC, USA.
Michinori ShiranoOsaka City General Hospital, Osaka, Japan.
Julia E SmithGSK Medicines Research Centre, Stevenage, UK.
Eduardo SprinzHospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
Charlotte SummersDept of Medicine, University of Cambridge School of Clinical Medicine, Cambridge, UK.ORCID 0000-0002-7269-2873
Nicolas TerziMédecine Intensive Réanimation, CHU Grenoble-Alpes, Grenoble, France.ORCID 0000-0003-4036-6245
Mark A TidswellPulmonary and Critical Care, Baystate Medical Centre, Springfield, MA, USA.
Yuliya TrefilovaPerm Regional Clinical Hospital, Perm, Russia.
Russell WilliamsonGSK Medicines Research Centre, Stevenage, UK.
Duncan WyncollDept of Critical Care, Guy's and St Thomas' NHS Foundation Trust, London, UK.
Mark LaytonGSK Medicines Research Centre, Stevenage, UK.
Age UK · GBGlaxoSmithKline (United States) · USInserm · FRResearch Triangle Park Foundation · USBaystate Medical Center · USBudgetary Healthcare Institution of Omsk Region Regional Clinical Hospital · RUCentre Hospitalier de Valenciennes · FRCentre Hospitalier Victor Dupouy · FRGlaxoSmithKline (Ireland) · IEGuy's and St Thomas' NHS Foundation Trust · GBHoly Cross Hospital · USHôpital Civil, Strasbourg · FRHospital Civil de Guadalajara · MXHospital de Clínicas de Porto Alegre · BRHospital Privado · ARLevine Cancer Institute · USMedisch Spectrum Twente · NLMelun Hospital · FRNewcastle upon Tyne Hospitals NHS Foundation Trust · GBOsaka City General Hospital · JP

Funding

Department of HealthWellcome Trust
6 · The paper itself

Abstract

backgroundGranulocyte-macrophage colony-stimulating factor (GM-CSF) and dysregulated myeloid cell responses are implicated in the pathophysiology and severity of COVID-19.

methodsIn this randomised, sequential, multicentre, placebo-controlled, double-blind study, adults aged 18-79 years (Part 1) or ≥70 years (Part 2) with severe COVID-19, respiratory failure and systemic inflammation (elevated C-reactive protein/ferritin) received a single intravenous infusion of otilimab 90 mg (human anti-GM-CSF monoclonal antibody) plus standard care (NCT04376684). The primary outcome was the proportion of patients alive and free of respiratory failure at Day 28.

resultsIn Part 1 (n=806 randomised 1:1 otilimab:placebo), 71% of otilimab-treated patients were alive and free of respiratory failure at Day 28

conclusionsThere was no significant difference in the proportion of patients alive and free of respiratory failure at Day 28. However, despite the lack of clinical benefit, a reduction in inflammatory markers was observed with otilimab, in addition to an acceptable safety profile.

Indexed as

COVID-19Respiratory InsufficiencyAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodGranulocyte-Macrophage Colony-Stimulating FactorHumansTreatment OutcomeAntibodies, Monoclonal, HumanizedGranulocyte-Macrophage Colony-Stimulating FactorOtilimab

Identifiers

PMID36229048
PMCPMC9558428
OpenAlexW4304957329

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.