RT Journal Article
T1 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.
A1 Franco-Moreno, Anabel
A1 Acedo-Gutiérrez, María Soledad
A1 Martín, Nicolás Labrador-San
A1 Hernández-Blanco, Clara
A1 Rodríguez-Olleros, Celia
A1 Ibáñez-Estéllez, Fátima
A1 Suárez-Simón, Ana
A1 Balado-Rico, Mateo
A1 Romero-Paternina, Ana Rocío
A1 Alonso-Menchén, David
A1 Escolano-Fernández, Belén
A1 Piniella-Ruiz, Esther
A1 Alonso-Monge, Ester
A1 Notario-Leo, Helena
A1 Bibiano-Guillén, Carlos
A1 Peña-Lillo, Gabriela
A1 Antiqueira-Pérez, Armando
A1 Romero-Pareja, Rodolfo
A1 Cabello-Clotet, Noemí
A1 Estrada-Pérez, Vicente
A1 Troya-García, Jesús
A1 de Carranza-López, María
A1 Escobar-Rodríguez, Ismael
A1 Vallejo-Maroto, Nacho
A1 Torres-Macho, Juan
K1 Adult respiratory distress syndrome
K1 COVID-19 pneumonia
K1 Corticosteroids
K1 Dexamethasone
K1 Inflammatory biological markers
K1 Laboratory markers
K1 Mortality
K1 Randomized controlled trial
AB 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. 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  245 U/L, C-reactive protein > 100 mg/L, and lymphocyte count of  100 mg/L, and lymphocyte count of  If our hypothesis is correct, the results of this study will provide additional insights into the management and progression of this specific subpopulation of patients with COVID-19 pneumonia without additional oxygen requirements and at risk of progressing to severe disease. ClinicalTrials.gov NCT04836780. Registered on 8 April 2021 as EARLY-DEX COVID-19.
YR 2022
FD 2022-09-15
LK http://hdl.handle.net/10668/20355
UL http://hdl.handle.net/10668/20355
LA en
DS RISalud
RD Apr 8, 2025