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Pilot prospective open, single-arm multicentre study on off-label use of tocilizumab in patients with severe COVID-19

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32

 

  1. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  2. ASL Città di Torino, Italy.
  3. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  4. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  5. ASL Città di Torino, Italy.
  6. ASL Città di Torino, Italy.
  7. ASL Città di Torino, Italy.
  8. ASL Città di Torino, Italy.
  9. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  10. ASL Città di Torino, Italy.
  11. ASL Città di Torino, Italy.
  12. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  13. ASL Città di Torino, Italy.
  14. ASL Città di Torino, Italy.
  15. ASL Città di Torino, Italy.
  16. ASL Città di Torino, Italy.
  17. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  18. ASL Città di Torino, Italy.
  19. ASL Città di Torino, Italy.
  20. ASL Città di Torino, Italy.
  21. ASL Città di Torino, Italy.
  22. ASL Città di Torino, Italy.
  23. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  24. ASL Città di Torino, Italy.
  25. ASL Città di Torino, Italy.
  26. ASL Città di Torino, Italy.
  27. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  28. ASL Città di Torino, Italy.
  29. ASL Città di Torino, Italy.
  30. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.
  31. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy. dario.roccatello@unito.it
  32. CMID, Centre of Research of Immunopathology and Rare Diseases, Coordinating Centre of the Network for Rare Diseases of Piemonte and Valle d'Aosta, ASL Città di Torino, Department of Clinical and Biological Sciences, University of Torino, and ASL Città di Torino, Italy.

CER13497
2020 Vol.38, N°3
PI 0529, PF 0532
Brief Papers

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PMID: 32359035 [PubMed]

Received: 26/04/2020
Accepted : 01/05/2020
In Press: 01/05/2020
Published: 26/05/2020

Abstract

OBJECTIVES:
No agent has yet been proven to be effective for the treatment of patients with severe COVID-19.
METHODS:
We conducted a pilot prospective open, single-arm multicentre study on off-label use of tocilizumab (TCZ) involving 63 hospitalised adult patients (56 males, age 62.6±12.5) with severe COVID-19. Clinical and laboratory parameters were prospectively collected at baseline, day 1, 2, 7 and 14. No moderate-to-severe adverse events attributable to TCZ were recorded.
RESULTS:
We observed a significant improvement in the levels of ferritin, C-reactive protein, D-dimer. The ratio of the partial pressure of oxygen (Pa02) to the fraction of inspired oxygen (Fi02) improved (mean±SD Pa02/Fi02 at admission: 152±53; at day 7: 283.73±115.9, at day 14: 302.2±126, p<0.05). The overall mortality was 11%; D-dimer level at baseline, but not IL-6 levels were predictors of mortality. TCZ administration within 6 days from admission in the hospital was associated with an increased likelihood of survival (HR 2.2 95%CI 1.3–6.7, p<0.05).
CONCLUSIONS:
In hospitalised adult patients with severe COVID-19, TCZ could be a safe option. An improvement in respiratory and laboratory parameters was observed. Future controlled trials in patients with severe illness are urgently needed to confirm the definite benefit with IL-6 target therapy.

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