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Prolonged higher dose methylprednisolone vs. conventional dexamethasone in COVID-19 pneumonia: a randomised controlled trial (MEDEAS).
Salton, Francesco; Confalonieri, Paola; Centanni, Stefano; Mondoni, Michele; Petrosillo, Nicola; Bonfanti, Paolo; Lapadula, Giuseppe; Lacedonia, Donato; Voza, Antonio; Carpenè, Nicoletta; Montico, Marcella; Reccardini, Nicolò; Meduri, Gianfranco Umberto; Ruaro, Barbara; Confalonieri, Marco.
  • Salton F; Department of Pulmonology, University Hospital of Cattinara, Trieste, Italy francesco.salton@asugi.sanita.fvg.it.
  • Confalonieri P; Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.
  • Centanni S; Department of Pulmonology, University Hospital of Cattinara, Trieste, Italy.
  • Mondoni M; Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.
  • Petrosillo N; Department of Health Sciences - Università degli Studi di Milano, Respiratory Unit ASST Santi Paolo e Carlo, Milan, Italy.
  • Bonfanti P; Department of Health Sciences - Università degli Studi di Milano, Respiratory Unit ASST Santi Paolo e Carlo, Milan, Italy.
  • Lapadula G; Head, Infection Prevention and Control-Infectious Disease Service, Foundation University Hospital Campus Bio-Medico, Rome, Italy.
  • Lacedonia D; Infectious Diseases Unit, ASST Monza, San Gerardo Hospital, Monza, Italy.
  • Voza A; School of Medicine, University of Milan-Bicocca, Milan, Italy.
  • Carpenè N; Infectious Diseases Unit, ASST Monza, San Gerardo Hospital, Monza, Italy.
  • Montico M; School of Medicine, University of Milan-Bicocca, Milan, Italy.
  • Reccardini N; Department of Medical and Surgical Science, University of Foggia, Policlinico Riuniti.
  • Meduri GU; Emergency Medicine Unit, IRCCS Humanitas Research Hospital, Milan, Italy.
  • Ruaro B; Pulmonary Unit, Cardio-Thoracic and Vascular Department, University Hospital of Pisa, Italy.
  • Confalonieri M; Department of Pulmonology, University Hospital of Cattinara, Trieste, Italy.
Eur Respir J ; 2022 Nov 10.
Article in English | MEDLINE | ID: covidwho-2303005
ABSTRACT

INTRODUCTION:

Dysregulated systemic inflammation is the primary driver of mortality in severe COVID-19 pneumonia. Current guidelines favor a 7-10-day course of any glucocorticoid equivalent to dexamethasone 6 mg·day-1. A comparative RCT with a higher dose and a longer duration of intervention was lacking.

METHODS:

We conducted a multi-center, open-label RCT to investigate methylprednisolone 80 mg as a continuous daily infusion for 8 days followed by slow tapering versus dexamethasone 6 mg daily for up to 10 days in adult patients with COVID-19 pneumonia requiring oxygen or noninvasive respiratory support. PRIMARY

OUTCOME:

reduction in 28-day mortality. SECONDARY

OUTCOMES:

mechanical ventilation-free days at 28 days, need for ICU referral, length of hospitalisation, need for tracheostomy, changes in PaO2FiO2 ratio, C-reactive protein levels and WHO clinical progression scale at days 3, 7, and 14.

RESULTS:

677 randomised patients were included. Findings are reported as methylprednisolone (n=337) versus dexamethasone (n=340). By day 28, there were no significant differences in mortality (35[10.4%] versus 41[12.1%]; p=0.49), nor in the median mechanical ventilation-free days (23[14] versus 24[16]; p=0.49). ICU referral was necessary in 41[12.2%] versus 45[13.2%]; p=0.68 and tracheostomy in 8[2.4%] versus 9[2.6%]; p=0.82. Survivors in the methylprednisolone group required a longer median hospitalisation (15[11] versus 14[11] days; p=0.005) and experienced an improvement in C-reactive protein levels, but not in PaO2FiO2 ratio, at days 7 and 14. There were no differences in disease progression at the prespecified timepoints.

CONCLUSION:

Prolonged, higher dose methylprednisolone did not reduce mortality at 28 days compared to conventional dexamethasone in COVID-19 pneumonia.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article Affiliation country: 13993003.01514-2022

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Language: English Year: 2022 Document Type: Article Affiliation country: 13993003.01514-2022