Anti-Granulocyte–Macrophage Colony–Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial

  1. Criner, Gerard J.
  2. Lang, Frederick ORCID logo
  3. Gottlieb, Robert ORCID logo
  4. Mathews, Kusum S.
  5. Wang, Tisha S.
  6. Rice, Todd W.
  7. Madduri, Deepu
  8. Bellam, Shashi
  9. Jeanfreau, Robert
  10. Case, Amy H.
  11. Glassberg, Marilyn K.
  12. Lyon, George Marshall
  13. Ahmad, Kareem
  14. Mendelson, Robert
  15. DiMaio, J. Michael
  16. Tran, MaryAnn P.
  17. Spak, Cedric W.
  18. Abbasi, Jamil A.
  19. Davis, Steven G.
  20. Ghamande, Shekhar
  21. Shen, Steven
  22. Sherman, Lisa
  23. Lowry, Simon

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1000 Titel
  • Anti-Granulocyte–Macrophage Colony–Stimulating Factor Monoclonal Antibody Gimsilumab for COVID-19 Pneumonia: A Randomized, Double-Blind, Placebo-controlled Trial
1000 Autor/in
  1. Criner, Gerard J. |
  2. Lang, Frederick |
  3. Gottlieb, Robert |
  4. Mathews, Kusum S. |
  5. Wang, Tisha S. |
  6. Rice, Todd W. |
  7. Madduri, Deepu |
  8. Bellam, Shashi |
  9. Jeanfreau, Robert |
  10. Case, Amy H. |
  11. Glassberg, Marilyn K. |
  12. Lyon, George Marshall |
  13. Ahmad, Kareem |
  14. Mendelson, Robert |
  15. DiMaio, J. Michael |
  16. Tran, MaryAnn P. |
  17. Spak, Cedric W. |
  18. Abbasi, Jamil A. |
  19. Davis, Steven G. |
  20. Ghamande, Shekhar |
  21. Shen, Steven |
  22. Sherman, Lisa |
  23. Lowry, Simon |
1000 Erscheinungsjahr 2022
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2022-06-01
1000 Erschienen in
1000 Quellenangabe
  • 205(11):1290-1299
1000 Copyrightjahr
  • 2022
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1164/rccm.202108-1859OC |
1000 Ergänzendes Material
  • https://www.atsjournals.org/doi/suppl/10.1164/rccm.202108-1859OC |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • RATIONALE: GM-CSF (granulocyte-macrophage colony-stimulating factor) has emerged as a promising target against the hyperactive host immune response associated with coronavirus disease (COVID-19). OBJECTIVES: We sought to investigate the efficacy and safety of gimsilumab, an anti-GM-CSF monoclonal antibody, for the treatment of hospitalized patients with elevated inflammatory markers and hypoxemia secondary to COVID-19. METHODS: We conducted a 24-week randomized, double-blind, placebo-controlled trial, BREATHE (Better Respiratory Education and Treatment Help Empower), at 21 locations in the United States. Patients were randomized 1:1 to receive two doses of intravenous gimsilumab or placebo 1 week apart. The primary endpoint was all-cause mortality rate at Day 43. Key secondary outcomes were ventilator-free survival rate, ventilator-free days, and time to hospital discharge. Enrollment was halted early for futility based on an interim analysis. MEASUREMENTS AND MAIN RESULTS: Of the planned 270 patients, 225 were randomized and dosed; 44.9% of patients were Hispanic or Latino. The gimsilumab and placebo groups experienced an all-cause mortality rate at Day 43 of 28.3% and 23.2%, respectively (adjusted difference = 5% vs. placebo; 95% confidence interval [26 to 17]; P = 0.377). Overall mortality rates at 24 weeks were similar across the treatment arms. The key secondary endpoints demonstrated no significant differences between groups. Despite the high background use of corticosteroids and anticoagulants, adverse events were generally balanced between treatment groups. CONCLUSIONS: Gimsilumab did not improve mortality or other key clinical outcomes in patients with COVID-19 pneumonia and evidence of systemic inflammation. The utility of anti-GM-CSF therapy for COVID-19 remains unclear. CLINICAL TRIAL registered with www.clinicaltrials.gov (NCT 04351243)
1000 Sacherschließung
gnd 1206347392 COVID-19
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
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1000 Erstellt am 2022-10-12T16:12:25.237+0200
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1000 Zuletzt bearbeitet Fri Oct 20 13:10:57 CEST 2023
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