1. Effect of EARLY administration of DEXamethasone in patients with COVID-19 pneumonia without acute hypoxemic respiratory failure and risk of development of acute respiratory distress syndrome (EARLY-DEX COVID-19): study protocol for a randomized controlled trial
- Author
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Anabel Franco-Moreno, María Soledad Acedo-Gutiérrez, Nicolás Labrador-San Martín, Clara Hernández-Blanco, Celia Rodríguez-Olleros, Fátima Ibáñez-Estéllez, Ana Suárez-Simón, Mateo Balado-Rico, Ana Rocío Romero-Paternina, David Alonso-Menchén, Belén Escolano-Fernández, Esther Piniella-Ruiz, Ester Alonso-Monge, Helena Notario-Leo, Carlos Bibiano-Guillén, Gabriela Peña-Lillo, Armando Antiqueira-Pérez, Rodolfo Romero-Pareja, Noemí Cabello-Clotet, Vicente Estrada-Pérez, Jesús Troya-García, María de Carranza-López, Ismael Escobar-Rodríguez, Nacho Vallejo-Maroto, and Juan Torres-Macho
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Adult respiratory distress syndrome ,Corticosteroids ,COVID-19 pneumonia ,Dexamethasone ,Inflammatory biological markers ,Laboratory markers ,Medicine (General) ,R5-920 - Abstract
Abstract Background Corticosteroids are one of the few drugs that have shown a reduction in mortality in coronavirus disease 2019 (COVID-19). In the RECOVERY trial, the use of dexamethasone reduced 28-day mortality compared to standard care in hospitalized patients with suspected or confirmed COVID-19 requiring supplemental oxygen or invasive mechanical ventilation. Evidence has shown that 30% of COVID-19 patients with mild symptoms at presentation will progress to acute respiratory distress syndrome (ARDS), particularly patients in whom laboratory inflammatory biomarkers associated with COVID-19 disease progression are detected. We postulated that dexamethasone treatment in hospitalized patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease might lead to a decrease in the development of ARDS and thereby reduce death. Methods/design This is a multicenter, randomized, controlled, parallel, open-label trial testing dexamethasone in 252 adult patients with COVID-19 pneumonia who do not require supplementary oxygen on admission but are at risk factors for the development of ARDS. Risk for the development of ARDS is defined as levels of lactate dehydrogenase > 245 U/L, C-reactive protein > 100 mg/L, and lymphocyte count of
- Published
- 2022
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