{"doi":"10.1183/13993003.01870-2021","title":"A randomised trial of anti-GM-CSF otilimab in severe COVID-19 pneumonia (OSCAR)","abstract":"BACKGROUND: Granulocyte-macrophage colony-stimulating factor (GM-CSF) and dysregulated myeloid cell responses are implicated in the pathophysiology and severity of COVID-19. METHODS: In 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. RESULTS: 67% who received placebo; the model-adjusted difference of 5.3% was not statistically significant (95% CI -0.8-11.4%, p=0.09). A nominally significant model-adjusted difference of 19.1% (95% CI 5.2-33.1%, p=0.009) was observed in the predefined 70-79 years subgroup, but this was not confirmed in Part 2 (n=350 randomised) where the model-adjusted difference was 0.9% (95% CI -9.3-11.2%, p=0.86). Compared with placebo, otilimab resulted in lower serum concentrations of key inflammatory markers, including the putative pharmacodynamic biomarker CC chemokine ligand 17, indicative of GM-CSF pathway blockade. Adverse events were comparable between groups and consistent with severe COVID-19. CONCLUSIONS: There 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.","journal":"European Respiratory Journal","year":2022,"id":241347,"datarank":1.336748484817846,"base_score":3.7612001156935624,"endowment":3.7612001156935624,"self_citation_contribution":0.5641800173540344,"citation_network_contribution":0.7725684674638115,"self_endowment_contribution":0.5641800173540344,"citer_contribution":0.7725684674638115,"corpus_percentile":null,"corpus_rank":null,"citation_count":42,"citer_count":39,"citers_with_citation_signal":32,"citers_with_endowment":32,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT04376684"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":623535,"name":"Damon Bass","orcid":"0000-0003-2480-5674","position":1,"is_corresponding":false},{"id":870176,"name":"Albertus Beishuizen","orcid":"0000-0002-0564-250X","position":2,"is_corresponding":false},{"id":870694,"name":"Xavier Bocca Ruiz","orcid":null,"position":3,"is_corresponding":false},{"id":870695,"name":"Hatem Boughanmi","orcid":null,"position":4,"is_corresponding":false},{"id":800157,"name":"Anthony Cahn","orcid":"0000-0002-7239-0461","position":5,"is_corresponding":false},{"id":633655,"name":"Hugo Colombo","orcid":null,"position":6,"is_corresponding":false},{"id":250084,"name":"Gerard J. Criner","orcid":"0000-0003-1267-3483","position":7,"is_corresponding":false},{"id":870696,"name":"Katherine Davy","orcid":null,"position":8,"is_corresponding":false},{"id":870177,"name":"Javier de Miguel‐Díez","orcid":"0000-0003-4543-573X","position":9,"is_corresponding":false},{"id":870697,"name":"Pablo Alexis Doreski","orcid":null,"position":10,"is_corresponding":false},{"id":870698,"name":"Sofia Fernandes","orcid":null,"position":11,"is_corresponding":false},{"id":850914,"name":"Bruno François","orcid":"0000-0002-2531-1652","position":12,"is_corresponding":false},{"id":640384,"name":"Anubha Gupta","orcid":"0000-0002-7752-1926","position":13,"is_corresponding":false},{"id":870178,"name":"Kate Hanrott","orcid":"0000-0002-9629-8491","position":14,"is_corresponding":false},{"id":846596,"name":"Timothy Hatlen","orcid":"0000-0003-3755-4309","position":15,"is_corresponding":false},{"id":870699,"name":"Dave Inman","orcid":null,"position":16,"is_corresponding":false},{"id":870179,"name":"John D. Isaacs","orcid":"0000-0002-6103-7056","position":17,"is_corresponding":false},{"id":870180,"name":"Emily Jarvis","orcid":"0000-0001-7187-6382","position":18,"is_corresponding":false},{"id":870181,"name":"N. E. Kostina","orcid":"0000-0002-5128-5005","position":19,"is_corresponding":false},{"id":870700,"name":"Tatiana Kropotina","orcid":null,"position":20,"is_corresponding":false},{"id":870701,"name":"Jean-Claude Lachérade","orcid":null,"position":21,"is_corresponding":false},{"id":870702,"name":"Divya Lakshminarayanan","orcid":null,"position":22,"is_corresponding":false},{"id":870182,"name":"Pedro Martínez-Ayala","orcid":"0000-0002-0505-6340","position":23,"is_corresponding":false},{"id":526913,"name":"Charlene McEvoy","orcid":"0000-0002-2813-9106","position":24,"is_corresponding":false},{"id":850934,"name":"Ferhat Meziani","orcid":"0000-0002-1005-9095","position":25,"is_corresponding":false},{"id":870703,"name":"Mehran Monchi","orcid":null,"position":26,"is_corresponding":false},{"id":826575,"name":"Sumanta Mukherjee","orcid":"0000-0001-7812-1257","position":27,"is_corresponding":false},{"id":870183,"name":"Rosana Muñoz-Bermúdez","orcid":"0000-0002-9210-3976","position":28,"is_corresponding":false},{"id":870704,"name":"Jessica Neisen","orcid":null,"position":29,"is_corresponding":false},{"id":870184,"name":"Ciara O’Shea","orcid":"0000-0003-4806-0507","position":30,"is_corresponding":false},{"id":850938,"name":"Gaëtan Plantefève","orcid":"0000-0003-3070-7368","position":31,"is_corresponding":false},{"id":870705,"name":"Lorrie Schifano","orcid":null,"position":32,"is_corresponding":false},{"id":870706,"name":"Lee Schwab","orcid":null,"position":33,"is_corresponding":false},{"id":870185,"name":"Zainab Shahid","orcid":"0000-0002-6664-8243","position":34,"is_corresponding":false},{"id":870186,"name":"Michinori Shirano","orcid":"0009-0007-6421-7478","position":35,"is_corresponding":false},{"id":870187,"name":"Julia E. Smith","orcid":"0000-0002-9634-9471","position":36,"is_corresponding":false},{"id":870188,"name":"Eduardo Sprinz","orcid":"0000-0003-4343-8304","position":37,"is_corresponding":false},{"id":81245,"name":"Charlotte Summers","orcid":"0000-0002-7269-2873","position":38,"is_corresponding":false},{"id":870189,"name":"Nicolas Terzi","orcid":"0000-0003-4036-6245","position":39,"is_corresponding":false},{"id":870190,"name":"Mark Tidswell","orcid":"0000-0001-6333-6810","position":40,"is_corresponding":false},{"id":870707,"name":"Yuliya Trefilova","orcid":null,"position":41,"is_corresponding":false},{"id":271273,"name":"R. Williamson","orcid":"0000-0001-9732-0964","position":42,"is_corresponding":false},{"id":870191,"name":"Duncan Wyncoll","orcid":"0000-0003-4685-5154","position":43,"is_corresponding":false},{"id":870192,"name":"Mark Layton","orcid":"0000-0002-1219-1321","position":44,"is_corresponding":false},{"id":870175,"name":"Jatin Patel","orcid":"0000-0003-3864-8753","position":0,"is_corresponding":true}],"reference_count":38,"raw_metadata":null,"created_at":"2026-07-19T00:22:56.227656Z","pmid":"36229048","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}