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.

Adrenal Cortex Hormones / adverse effects Adult C-Reactive Protein COVID-19 / complications Dexamethasone / adverse effects Humans Lactate Dehydrogenases Multicenter Studies as Topic Oxygen Pneumonia / drug therapy Randomized Controlled Trials as Topic Respiratory Distress Syndrome / epidemiology Respiratory Insufficiency / epidemiology COVID-19 Drug Treatment

Adult respiratory distress syndrome COVID-19 pneumonia Corticosteroids Dexamethasone Inflammatory biological markers Laboratory markers Mortality Randomized controlled trial

Journal

Trials

ISSN: 1745-6215

Titre abrégé: Trials

Pays: England

ID NLM: 101263253

Informations de publication

Date de publication:
15 Sep 2022

Historique:

received: 21 11 2021

accepted: 08 09 2022

entrez: 15 9 2022

pubmed: 16 9 2022

medline: 20 9 2022

Statut: epublish

Résumé

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 < 0.80 × 10 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.

Sections du résumé

BACKGROUND BACKGROUND

METHODS/DESIGN METHODS

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 < 0.80 × 10

DISCUSSION CONCLUSIONS

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.

TRIAL REGISTRATION BACKGROUND

ClinicalTrials.gov NCT04836780. Registered on 8 April 2021 as EARLY-DEX COVID-19.

Identifiants

DOI: 10.1186/s13063-022-06722-x PMID: 36109825 PMC: PMC9479245

pubmed: 36109825

doi: 10.1186/s13063-022-06722-x

pii: 10.1186/s13063-022-06722-x

pmc: PMC9479245

doi:

Substances chimiques

Adrenal Cortex Hormones 0

Dexamethasone 7S5I7G3JQL

C-Reactive Protein 9007-41-4

Lactate Dehydrogenases EC 1.1.-

Oxygen S88TT14065

Banques de données

ClinicalTrials.gov

['NCT04836780']

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

784

Informations de copyright

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