tetano
Editor, Senior Moderator
Eur Respir J
. 2022 Mar 31;2200025.
doi: 10.1183/13993003.00025-2022. Online ahead of print.
Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial
Carlo Salvarani[SUP] 1 2 3 [/SUP], Marco Massari[SUP] 4 3 [/SUP], Massimo Costantini[SUP] 5 [/SUP], Domenico Franco Merlo[SUP] 6 [/SUP], Gabriella Lucia Mariani[SUP] 6 [/SUP], Pierluigi Viale[SUP] 7 [/SUP], Stefano Nava[SUP] 8 [/SUP], Giovanni Guaraldi[SUP] 9 [/SUP], Giovanni Dolci[SUP] 9 [/SUP], Luca Boni[SUP] 10 [/SUP], Luisa Savoldi[SUP] 6 [/SUP], Paolo Bruzzi[SUP] 10 [/SUP], Caterina Turrà[SUP] 11 [/SUP], Mariagrazia Catanoso[SUP] 12 [/SUP], Anna Maria Marata[SUP] 13 [/SUP], Chiara Barbieri[SUP] 14 [/SUP], Annamaria Valcavi[SUP] 11 [/SUP], Francesca Franzoni[SUP] 6 [/SUP], Silvio Cavuto[SUP] 6 [/SUP], Giorgio Mazzi[SUP] 15 [/SUP], Romina Corsini[SUP] 4 [/SUP], Fabio Trapani[SUP] 7 [/SUP], Alessandro Bartoloni[SUP] 16 17 [/SUP], Emanuela Barisione[SUP] 18 [/SUP], Chiara Barbieri[SUP] 19 [/SUP], Giulia Jole Burastero[SUP] 9 [/SUP], Angelo Pan[SUP] 9 [/SUP], Walter Inojosa[SUP] 20 [/SUP], Raffaele Scala[SUP] 21 [/SUP], Cecilia Burattini[SUP] 22 [/SUP], Fabrizio Luppi[SUP] 23 [/SUP], Mauro Codeluppi[SUP] 24 [/SUP], Kamal Eldin Tarek[SUP] 25 [/SUP], Giovanni Cenderello[SUP] 26 [/SUP], Mario Salio[SUP] 27 [/SUP], Giuseppe Foti[SUP] 28 [/SUP], Roberto Dongilli[SUP] 29 [/SUP], Gianluigi Bajocchi[SUP] 12 [/SUP], Emanuele Alberto Negri[SUP] 30 [/SUP], Giacomo Ciusa[SUP] 4 9 [/SUP], Giacomo Fornaro[SUP] 7 [/SUP], Ilaria Bassi[SUP] 8 [/SUP], Lorenzo Zammarchi[SUP] 16 17 [/SUP], Teresita Aloè[SUP] 18 [/SUP], Nicola Facciolongo[SUP] 8 [/SUP]
Affiliations
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 Mar 31;2200025.
doi: 10.1183/13993003.00025-2022. Online ahead of print.
Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial
Carlo Salvarani[SUP] 1 2 3 [/SUP], Marco Massari[SUP] 4 3 [/SUP], Massimo Costantini[SUP] 5 [/SUP], Domenico Franco Merlo[SUP] 6 [/SUP], Gabriella Lucia Mariani[SUP] 6 [/SUP], Pierluigi Viale[SUP] 7 [/SUP], Stefano Nava[SUP] 8 [/SUP], Giovanni Guaraldi[SUP] 9 [/SUP], Giovanni Dolci[SUP] 9 [/SUP], Luca Boni[SUP] 10 [/SUP], Luisa Savoldi[SUP] 6 [/SUP], Paolo Bruzzi[SUP] 10 [/SUP], Caterina Turrà[SUP] 11 [/SUP], Mariagrazia Catanoso[SUP] 12 [/SUP], Anna Maria Marata[SUP] 13 [/SUP], Chiara Barbieri[SUP] 14 [/SUP], Annamaria Valcavi[SUP] 11 [/SUP], Francesca Franzoni[SUP] 6 [/SUP], Silvio Cavuto[SUP] 6 [/SUP], Giorgio Mazzi[SUP] 15 [/SUP], Romina Corsini[SUP] 4 [/SUP], Fabio Trapani[SUP] 7 [/SUP], Alessandro Bartoloni[SUP] 16 17 [/SUP], Emanuela Barisione[SUP] 18 [/SUP], Chiara Barbieri[SUP] 19 [/SUP], Giulia Jole Burastero[SUP] 9 [/SUP], Angelo Pan[SUP] 9 [/SUP], Walter Inojosa[SUP] 20 [/SUP], Raffaele Scala[SUP] 21 [/SUP], Cecilia Burattini[SUP] 22 [/SUP], Fabrizio Luppi[SUP] 23 [/SUP], Mauro Codeluppi[SUP] 24 [/SUP], Kamal Eldin Tarek[SUP] 25 [/SUP], Giovanni Cenderello[SUP] 26 [/SUP], Mario Salio[SUP] 27 [/SUP], Giuseppe Foti[SUP] 28 [/SUP], Roberto Dongilli[SUP] 29 [/SUP], Gianluigi Bajocchi[SUP] 12 [/SUP], Emanuele Alberto Negri[SUP] 30 [/SUP], Giacomo Ciusa[SUP] 4 9 [/SUP], Giacomo Fornaro[SUP] 7 [/SUP], Ilaria Bassi[SUP] 8 [/SUP], Lorenzo Zammarchi[SUP] 16 17 [/SUP], Teresita Aloè[SUP] 18 [/SUP], Nicola Facciolongo[SUP] 8 [/SUP]
Affiliations
- PMID: 35361632
- DOI: 10.1183/13993003.00025-2022
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.