ArticleMayo Clinic proceedings2020
GM-CSF Neutralization With Lenzilumab in Severe COVID-19 Pneumonia: A Case-Cohort Study.
Article in Mayo Clinic proceedings, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04351152 (A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia), which is not on this map. Cited by 63 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia
Who cites it
63 citing papers in PubMed, 2 syntheses or guidelines pooled it, 87 citations in OpenAlex.
- Efficacy and safety of granulocyte-macrophage colony-stimulating factor (GM-CSF) antibodies in COVID-19 patients: a meta-analysis.Inflammopharmacology · 2023Pooled it
- Immunomodulatory therapies for SARS-CoV-2 infection: a systematic literature review to inform EULAR points to consider.Annals of the rheumatic diseases · 2021Pooled it
- Anti-Granulocyte-Macrophage Colony-Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial.American journal of respiratory and critical care medicine · 2022Trial
- Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial.The Lancet. Respiratory medicine · 2022Trial
- Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial.The Lancet. Respiratory medicine · 2022Trial
- Cytokine Profiles in Peripheral Blood Mononuclear Cells and Neutrophils following SARS-CoV-2 Vaccination: A Study from Kuwait.Medical principles and practice : international journal of the Kuwait University, Health Science Centre · 2026Article
- Airway Delivery of Encapsulated Cytokine-Secreting Cells for Local Immunomodulation in Inflammatory Lung Diseases.Research square · 2025Article
- Renal denervation achieves its antiarrhythmic effect through attenuating macrophage activation and neuroinflammation in stellate ganglia in chronic heart failure.Cardiovascular research · 2025Article
- Advances in acute respiratory distress syndrome: focusing on heterogeneity, pathophysiology, and therapeutic strategies.Signal transduction and targeted therapy · 2025Review
- Review of COVID-19 Therapeutics by Mechanism: From Discovery to Approval.Journal of Korean medical science · 2024Review
- Tissue-resident memory T cells and lung immunopathology.Immunological reviews · 2023Review
- Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial.BMC pharmacology & toxicology · 2023Article
- Host-Based Treatments for Severe COVID-19.Current issues in molecular biology · 2023Review
- Treatment with Granulocyte-Macrophage Colony-Stimulating Factor Reduces Viral Titers in the Brains of West Nile Virus-Infected Mice and Improves Survival.Journal of virology · 2023Article
- An overview on the treatments and prevention against COVID-19.Virology journal · 2023Review
- Cytokines and microRNAs in SARS-CoV-2: What do we know?Molecular therapy. Nucleic acids · 2022Review
- Review
- Recent advances in passive immunotherapies for COVID-19: The Evidence-Based approaches and clinical trials.International immunopharmacology · 2022Review
- Immune Signature of COVID-19: In-Depth Reasons and Consequences of the Cytokine Storm.International journal of molecular sciences · 2022Review
- A global picture: therapeutic perspectives for COVID-19.Immunotherapy · 2022Review
3 more citing papers are in PubMed but not listed here.
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Authors and funding
21 authors at 5 institutions in 1 country.
Funding
Abstract
objectiveTo assess the efficacy and safety of lenzilumab in patients with severe coronavirus disease 2019 (COVID-19) pneumonia.
methodsHospitalized patients with COVID-19 pneumonia and risk factors for poor outcomes were treated with lenzilumab 600 mg intravenously for three doses through an emergency single-use investigational new drug application. Patient characteristics, clinical and laboratory outcomes, and adverse events were recorded. We also identified a cohort of patients matched to the lenzilumab patients for age, sex, and disease severity. Study dates were March 13, 2020, to June 18, 2020. All patients were followed through hospital discharge or death.
resultsTwelve patients were treated with lenzilumab; 27 patients comprised the matched control cohort (untreated). Clinical improvement, defined as improvement of at least 2 points on the 8-point ordinal clinical endpoints scale, was observed in 11 of 12 (91.7%) patients treated with lenzilumab and 22 of 27 (81.5%) untreated patients. The time to clinical improvement was significantly shorter for the lenzilumab-treated group compared with the untreated cohort with a median of 5 days versus 11 days (P=.006). Similarly, the proportion of patients with acute respiratory distress syndrome (oxygen saturation/fraction of inspired oxygen<315 mm Hg) was significantly reduced over time when treated with lenzilumab compared with untreated (P<.001). Significant improvement in inflammatory markers (C-reactive protein and interleukin 6) and markers of disease severity (absolute lymphocyte count) were observed in patients who received lenzilumab, but not in untreated patients. Cytokine analysis showed a reduction in inflammatory myeloid cells 2 days after lenzilumab treatment. There were no treatment-emergent adverse events attributable to lenzilumab.
conclusionIn high-risk COVID-19 patients with severe pneumonia, granulocyte-macrophage colony-stimulating factor neutralization with lenzilumab was safe and associated with faster improvement in clinical outcomes, including oxygenation, and greater reductions in inflammatory markers compared with a matched control cohort of patients hospitalized with severe COVID-19 pneumonia. A randomized, placebo-controlled clinical trial to validate these findings is ongoing (NCT04351152).
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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.