Rationale: Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia. Methods: In this multicenter, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with Covid-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for 3 consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of the patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need of supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival. Results: Overall, 112 of 151 (75.4%) patients in the pulse methylprednisolone arm and 111 of 150 (75.2%) in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups [15 days (95% confidence interval (CI), 13.0 to 17.0) and 16 days (95%CI, 13.8 to 18.2); hazard ratio (HR), 0.92; 95% CI 0.71-1.20; p=0.528]. No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to Intensive Care Unit with orotracheal intubation or death (20.0% versus 16.1%; HR, 1.26; 95%CI, 0.74-2.16; p=0.176), or overall mortality (10.0% versus 12.2%; HR, 0.83; 95%CI, 0.42-1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups. Conclusions: Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia. Message of the study: Pulse glucocorticoid therapy is used for severe and/or life threatening immuno-inflammatory diseases. The addition of pulse glucocorticoid therapy to the standard low dose of dexamethasone scheme was not of benefit in patients with COVID-19 pneumonia.

Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial / Salvarani, Carlo; Massari, Marco; Costantini, Massimo; Franco Merlo, Domenico; Lucia Mariani, Gabriella; Viale, Pierluigi; Nava, Stefano; Guaraldi, Giovanni; Dolci, Giovanni; Boni, Luca; Savoldi, Luisa; Bruzzi, Paolo; Turrà, Caterina; Catanoso, Mariagrazia; Maria Marata, Anna; Barbieri, Chiara; Valcavi, Annamaria; Franzoni, Francesca; Cavuto, Silvio; Mazzi, Giorgio; Corsini, Romina; Trapani, Fabio; Bartoloni, Alessandro; Barisione, Emanuela; Barbieri, Chiara; Jole Burastero, Giulia; Pan, Angelo; Inojosa, Walter; Scala, Raffaele; Burattini, Cecilia; Luppi, Fabrizio; Codeluppi, Mauro; Eldin Tarek, Kamal; Cenderello, Giovanni; Salio, Mario; Foti, Giuseppe; Dongilli, Roberto; Bajocchi, Gianluigi; Alberto Negri, Emanuele; Ciusa, Giacomo; Fornaro, Giacomo; Bassi, Ilaria; Zammarchi, Lorenzo; Aloè, Teresita; Facciolongo, Nicola. - In: EUROPEAN RESPIRATORY JOURNAL. - ISSN 0903-1936. - 60:4(2022), pp. 2200025-2200025. [10.1183/13993003.00025-2022]

Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial

Salvarani, Carlo;Guaraldi, Giovanni;Dolci, Giovanni;Ciusa, Giacomo;
2022

Abstract

Rationale: Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia. Methods: In this multicenter, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with Covid-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for 3 consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of the patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need of supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival. Results: Overall, 112 of 151 (75.4%) patients in the pulse methylprednisolone arm and 111 of 150 (75.2%) in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups [15 days (95% confidence interval (CI), 13.0 to 17.0) and 16 days (95%CI, 13.8 to 18.2); hazard ratio (HR), 0.92; 95% CI 0.71-1.20; p=0.528]. No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to Intensive Care Unit with orotracheal intubation or death (20.0% versus 16.1%; HR, 1.26; 95%CI, 0.74-2.16; p=0.176), or overall mortality (10.0% versus 12.2%; HR, 0.83; 95%CI, 0.42-1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups. Conclusions: Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia. Message of the study: Pulse glucocorticoid therapy is used for severe and/or life threatening immuno-inflammatory diseases. The addition of pulse glucocorticoid therapy to the standard low dose of dexamethasone scheme was not of benefit in patients with COVID-19 pneumonia.
2022
60
4
2200025
2200025
Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial / Salvarani, Carlo; Massari, Marco; Costantini, Massimo; Franco Merlo, Domenico; Lucia Mariani, Gabriella; Viale, Pierluigi; Nava, Stefano; Guaraldi, Giovanni; Dolci, Giovanni; Boni, Luca; Savoldi, Luisa; Bruzzi, Paolo; Turrà, Caterina; Catanoso, Mariagrazia; Maria Marata, Anna; Barbieri, Chiara; Valcavi, Annamaria; Franzoni, Francesca; Cavuto, Silvio; Mazzi, Giorgio; Corsini, Romina; Trapani, Fabio; Bartoloni, Alessandro; Barisione, Emanuela; Barbieri, Chiara; Jole Burastero, Giulia; Pan, Angelo; Inojosa, Walter; Scala, Raffaele; Burattini, Cecilia; Luppi, Fabrizio; Codeluppi, Mauro; Eldin Tarek, Kamal; Cenderello, Giovanni; Salio, Mario; Foti, Giuseppe; Dongilli, Roberto; Bajocchi, Gianluigi; Alberto Negri, Emanuele; Ciusa, Giacomo; Fornaro, Giacomo; Bassi, Ilaria; Zammarchi, Lorenzo; Aloè, Teresita; Facciolongo, Nicola. - In: EUROPEAN RESPIRATORY JOURNAL. - ISSN 0903-1936. - 60:4(2022), pp. 2200025-2200025. [10.1183/13993003.00025-2022]
Salvarani, Carlo; Massari, Marco; Costantini, Massimo; Franco Merlo, Domenico; Lucia Mariani, Gabriella; Viale, Pierluigi; Nava, Stefano; Guaraldi, Gi...espandi
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