Article ; Online: 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.
2022 Volume 23, Issue 1, Page(s) 784
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 ... ...
| 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 < 0.80 × 10 Discussion: 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: ClinicalTrials.gov NCT04836780. Registered on 8 April 2021 as EARLY-DEX COVID-19. |
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| MeSH term(s) | Adrenal Cortex Hormones/adverse effects ; Adult ; C-Reactive Protein ; COVID-19/complications ; COVID-19/drug therapy ; 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 |
| Chemical Substances | Adrenal Cortex Hormones ; Dexamethasone (7S5I7G3JQL) ; C-Reactive Protein (9007-41-4) ; Lactate Dehydrogenases (EC 1.1.-) ; Oxygen (S88TT14065) |
| Language | English |
| Publishing date | 2022-09-15 |
| Publishing country | England |
| Document type | Clinical Trial Protocol ; Journal Article |
| ZDB-ID | 2040523-6 |
| ISSN | 1745-6215 ; 1468-6694 ; 1745-6215 |
| ISSN (online) | 1745-6215 |
| ISSN | 1468-6694 ; 1745-6215 |
| DOI | 10.1186/s13063-022-06722-x |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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