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

Autor: Martina Bonifazi, Donato Lacedonia, Anna Talia Gaccione, Luca Guidelli, Barbara Ruaro, Venerino Poletti, Claudia Ravaglia, Marco Confalonieri, Lucio Torelli, Paola Confalonieri, Massimiliano Villani, Alessandro Marcello, Sergio Harari, Francesco Salton, Maria Concetta Volpe, Matteo Davì, G. Umberto Meduri, Mario Tamburrini, Andrea Vianello, Annalisa Casarin, Danilo Licastro, Reba Umberger, Pierachille Santus, Raffaele Scala, Stefano Gasparini, Tiberio Oggionni, Antonella Zucchetto, Stefano Centanni, Maria Pia Foschino Barbaro, Rita Raccanelli, Mara Parati, Marcella Montico, Alberto Fantin, Pierlanfranco D'Agaro, Valentina Vertui, Xueyuan Cao, Dejan Radovanovic, Antonella Caminati, Vincenzo Patruno, Paolo Lucernoni, Alessandro Scartabellati, S. Tomassetti, Micaela Romagnoli, Simone Lanini, Michele Mondoni
Přispěvatelé: Salton, Francesco, Confalonieri, Paola, Umberto Meduri, G, Santus, Pierachille, Harari, Sergio, Scala, Raffaele, Lanini, Simone, Vertui, Valentina, Oggionni, Tiberio, Caminati, Antonella, Patruno, Vincenzo, Tamburrini, Mario, Scartabellati, Alessandro, Parati, Mara, Villani, Massimiliano, Radovanovic, Dejan, Tomassetti, Sara, Ravaglia, Claudia, Poletti, Venerino, Vianello, Andrea, Talia Gaccione, Anna, Guidelli, Luca, Raccanelli, Rita, Lucernoni, Paolo, Lacedonia, Donato, Pia Foschino Barbaro, Maria, Centanni, Stefano, Mondoni, Michele, Davì, Matteo, Fantin, Alberto, Cao, Xueyuan, Torelli, Lucio, Zucchetto, Antonella, Montico, Marcella, Casarin, Annalisa, Romagnoli, Micaela, Gasparini, Stefano, Bonifazi, Martina, D'Agaro, Pierlanfranco, Marcello, Alessandro, Licastro, Danilo, Ruaro, Barbara, Volpe, MARIA CONCETTA, Umberger, Reba, Confalonieri, Marco
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Open Forum Infectious Diseases
Popis: Background In hospitalized patients with coronavirus disease 2019 (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 intensive care unit (ICU) admission 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 end point) 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 end point was met by 19 vs 40 (adjusted hazard ratio [aHR], 0.41; 95% CI, 0.24–0.72). Transfer to ICU and invasive MV were necessary in 15 vs 27 (P = .07) and 14 vs 26 (P = .10), respectively. By day 28, the MP group had fewer deaths (6 vs 21; aHR, 0.29; 95% CI, 0.12–0.73) and more days off invasive MV (24.0 ± 9.0 vs 17.5 ± 12.8; P = .001). Study treatment was associated with rapid improvement in PaO2:FiO2 and CRP levels. The complication rate was similar for the 2 groups (P = .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. Treatment was safe and did not impact viral clearance. A large randomized controlled trial (RECOVERY trial) has been performed that validates these findings. Clinical trial registration. ClinicalTrials.gov NCT04323592.
This multicenter observational study gave the first evidence that prolonged, low-dose methylprednisolone treatment is associated with a significantly lower hazard of death, reduced ICU burden and decreased ventilator dependence without affecting viral clearance in patients with severe COVID-19 pneumonia/ARDS.
Databáze: OpenAIRE
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