Prolonged low-dose methylprednisolone in patients with severe COVID-19 pneumonia

  1. Francesco Salton
  2. Paola Confalonieri
  3. Pierachille Santus
  4. Sergio Harari
  5. Raffaele Scala
  6. Simone Lanini
  7. Valentina Vertui
  8. Tiberio Oggionni
  9. Antonella Caminati
  10. Vincenzo Patruno
  11. Mario Tamburrini
  12. Alessandro Scartabellati
  13. Mara Parati
  14. Massimiliano Villani
  15. Dejan Radovanovic
  16. Sara Tomassetti
  17. Claudia Ravaglia
  18. Venerino Poletti
  19. Andrea Vianello
  20. Anna Talia Gaccione
  21. Luca Guidelli
  22. Rita Raccanelli
  23. Paolo Lucernoni
  24. Donato Lacedonia
  25. Maria Pia Foschino Barbaro
  26. Stefano Centanni
  27. Michele Mondoni
  28. Matteo Davì
  29. Alberto Fantin
  30. Xueyuan Cao
  31. Lucio Torelli
  32. Antonella Zucchetto
  33. Marcella Montico
  34. Annalisa Casarin
  35. Micaela Romagnoli
  36. Stefano Gasparini
  37. Martina Bonifazi
  38. Pierlanfranco D’Agaro
  39. Alessandro Marcello
  40. Danilo Licastro
  41. Barbara Ruaro
  42. Maria Concetta Volpe
  43. Reba Umberger
  44. Umberto Meduri
  45. Marco Confalonieri
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Abstract

Background

In hospitalized patients with COVID-19 pneumonia, progression to acute respiratory failure requiring invasive mechanical ventilation (MV) is associated with significant morbidity and mortality. Severe dysregulated systemic inflammation is the putative mechanism. We hypothesize that early prolonged methylprednisolone (MP) treatment could accelerate disease resolution, decreasing the need for ICU and mortality.

Methods

We conducted a multicenter, observational study to explore the association between exposure to prolonged, low-dose, MP treatment and need for ICU referral, intubation or death within 28 days (composite primary endpoint) in patients with severe COVID-19 pneumonia admitted to Italian respiratory high-dependency units. Secondary outcomes were invasive MV-free days and changes in C-reactive protein (CRP) levels.

Results

Findings are reported as MP (n=83) vs. control (n=90). The composite primary endpoint was met by 19 vs. 40 [adjusted hazard ratio (HR) 0.41; 95% confidence interval (CI): 0.24-0.72]. Transfer to ICU and need for invasive MV was necessary in 15 vs. 27 (p=0.07) and 14 vs. 26 (p=0.10), respectively. By day 28, the MP group had fewer deaths (6 vs. 21, adjusted HR=0.29; 95% CI: 0.12-0.73) and more days off invasive MV (24.0 ± 9.0 vs. 17.5 ± 12.8; p=0.001). Study treatment was associated with rapid improvement in PaO2:FiO2 and CRP levels. The complication rate was similar for the two groups (p=0.84).

Conclusion

In patients with severe COVID-19 pneumonia, early administration of prolonged MP treatment was associated with a significantly lower hazard of death (71%) and decreased ventilator dependence. Randomized controlled studies are needed to confirm these findings.

Registration

ClinicalTrials.gov. Identifier: <ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT04323592">NCT04323592</ext-link>

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