Pilot prospective open, single-arm multicentre study on off-label use of tocilizumab in patients with severe COVID-19
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.
| Medienart: |
Artikel |
|---|
| Erscheinungsjahr: |
2020 |
|---|---|
| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:38 |
|---|---|
| Enthalten in: |
Clinical and experimental rheumatology - 38(2020), 3 vom: 15. Mai, Seite 529-532 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Sciascia, Savino [VerfasserIn] |
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| Themen: |
Antibodies, Monoclonal, Humanized |
|---|
| Anmerkungen: |
Date Completed 29.05.2020 Date Revised 18.12.2020 published: Print-Electronic Citation Status MEDLINE |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM309426529 |
|---|
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| 041 | |a eng | ||
| 100 | 1 | |a Sciascia, Savino |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Pilot prospective open, single-arm multicentre study on off-label use of tocilizumab in patients with severe COVID-19 |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
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| 500 | |a Date Completed 29.05.2020 | ||
| 500 | |a Date Revised 18.12.2020 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVES: No agent has yet been proven to be effective for the treatment of patients with severe COVID-19 | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Boaro, Daniela |e verfasserin |4 aut | |
| 700 | 1 | |a Boero, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Bonora, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Calcagno, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Cecchi, Irene |e verfasserin |4 aut | |
| 700 | 1 | |a Cinnirella, Giacoma |e verfasserin |4 aut | |
| 700 | 1 | |a Converso, Marcella |e verfasserin |4 aut | |
| 700 | 1 | |a Cozzi, Martina |e verfasserin |4 aut | |
| 700 | 1 | |a Crosasso, Paola |e verfasserin |4 aut | |
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| 700 | 1 | |a Imperiale, Daniele |e verfasserin |4 aut | |
| 700 | 1 | |a Imperiale, Gianlorenzo |e verfasserin |4 aut | |
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| 700 | 1 | |a Manno, Emilpaolo |e verfasserin |4 aut | |
| 700 | 1 | |a Massara, Carlo |e verfasserin |4 aut | |
| 700 | 1 | |a Milone, Valeria |e verfasserin |4 aut | |
| 700 | 1 | |a Natale, Giuseppe |e verfasserin |4 aut | |
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| 700 | 1 | |a Rossi, Daniela |e verfasserin |4 aut | |
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