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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.

dc.contributor.authorFranco-Moreno, Anabel
dc.contributor.authorAcedo-Gutiérrez, María Soledad
dc.contributor.authorMartín, Nicolás Labrador-San
dc.contributor.authorHernández-Blanco, Clara
dc.contributor.authorRodríguez-Olleros, Celia
dc.contributor.authorIbáñez-Estéllez, Fátima
dc.contributor.authorSuárez-Simón, Ana
dc.contributor.authorBalado-Rico, Mateo
dc.contributor.authorRomero-Paternina, Ana Rocío
dc.contributor.authorAlonso-Menchén, David
dc.contributor.authorEscolano-Fernández, Belén
dc.contributor.authorPiniella-Ruiz, Esther
dc.contributor.authorAlonso-Monge, Ester
dc.contributor.authorNotario-Leo, Helena
dc.contributor.authorBibiano-Guillén, Carlos
dc.contributor.authorPeña-Lillo, Gabriela
dc.contributor.authorAntiqueira-Pérez, Armando
dc.contributor.authorRomero-Pareja, Rodolfo
dc.contributor.authorCabello-Clotet, Noemí
dc.contributor.authorEstrada-Pérez, Vicente
dc.contributor.authorTroya-García, Jesús
dc.contributor.authorde Carranza-López, María
dc.contributor.authorEscobar-Rodríguez, Ismael
dc.contributor.authorVallejo-Maroto, Nacho
dc.contributor.authorTorres-Macho, Juan
dc.date.accessioned2023-05-03T13:34:56Z
dc.date.available2023-05-03T13:34:56Z
dc.date.issued2022-09-15
dc.description.abstractCorticosteroids 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.
dc.identifier.doi10.1186/s13063-022-06722-x
dc.identifier.essn1745-6215
dc.identifier.pmcPMC9479245
dc.identifier.pmid36109825
dc.identifier.pubmedURLhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9479245/pdf
dc.identifier.unpaywallURLhttps://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-022-06722-x
dc.identifier.urihttp://hdl.handle.net/10668/20355
dc.issue.number1
dc.journal.titleTrials
dc.journal.titleabbreviationTrials
dc.language.isoen
dc.organizationHospital Universitario Virgen del Rocío
dc.page.number784
dc.pubmedtypeClinical Trial Protocol
dc.pubmedtypeJournal Article
dc.rightsAttribution 4.0 International
dc.rights.accessRightsopen access
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectAdult respiratory distress syndrome
dc.subjectCOVID-19 pneumonia
dc.subjectCorticosteroids
dc.subjectDexamethasone
dc.subjectInflammatory biological markers
dc.subjectLaboratory markers
dc.subjectMortality
dc.subjectRandomized controlled trial
dc.subject.meshAdrenal Cortex Hormones
dc.subject.meshAdult
dc.subject.meshC-Reactive Protein
dc.subject.meshCOVID-19
dc.subject.meshDexamethasone
dc.subject.meshHumans
dc.subject.meshLactate Dehydrogenases
dc.subject.meshMulticenter Studies as Topic
dc.subject.meshOxygen
dc.subject.meshPneumonia
dc.subject.meshRandomized Controlled Trials as Topic
dc.subject.meshRespiratory Distress Syndrome
dc.subject.meshRespiratory Insufficiency
dc.subject.meshCOVID-19 Drug Treatment
dc.titleEffect 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.
dc.typeresearch article
dc.type.hasVersionVoR
dc.volume.number23
dspace.entity.typePublication

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