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

No agent has yet been proven to be effective for the treatment of patients with severe COVID-19. 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...

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Bibliographic Details
Published in:Clinical and experimental rheumatology Vol. 38; no. 3; p. 529
Main Authors: Sciascia, Savino, Aprà, Franco, Baffa, Alessandra, Baldovino, Simone, Boaro, Daniela, Boero, Roberto, Bonora, Stefano, Calcagno, Andrea, Cecchi, Irene, Cinnirella, Giacoma, Converso, Marcella, Cozzi, Martina, Crosasso, Paola, De Iaco, Fabio, Di Perri, Giovanni, Eandi, Mario, Fenoglio, Roberta, Giusti, Massimo, Imperiale, Daniele, Imperiale, Gianlorenzo, Livigni, Sergio, Manno, Emilpaolo, Massara, Carlo, Milone, Valeria, Natale, Giuseppe, Navarra, Mauro, Oddone, Valentina, Osella, Sara, Piccioni, Pavilio, Radin, Massimo, Roccatello, Dario, Rossi, Daniela
Format: Journal Article
Language:English
Published: Italy 01.05.2020
Subjects:
Aged
Antibodies, Monoclonal, Humanized - therapeutic use
Betacoronavirus
Coronavirus Infections - therapy
COVID-19
Female
Humans
Male
Middle Aged
Off-Label Use
Pandemics
Pilot Projects
Pneumonia, Viral - therapy
Prospective Studies
Receptors, Interleukin-6 - antagonists & inhibitors
SARS-CoV-2
Treatment Outcome
ISSN:0392-856X
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Summary:No agent has yet been proven to be effective for the treatment of patients with severe COVID-19. 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. 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). 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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ISSN:0392-856X